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Peter J Goadsby - One of the best experts on this subject based on the ideXlab platform.

  • two year efficacy and safety of erenumab in participants with Episodic Migraine and 2 4 prior preventive treatment failures results from the liberty study
    Journal of Neurology Neurosurgery and Psychiatry, 2021
    Co-Authors: Michel D Ferrari, Peter J Goadsby, Uwe Reuter, Shihua Wen, Gabriel Paiva Da Silva Lima, Subhayan Mondal, Nadia Tenenbaum, Shaloo Pandhi
    Abstract:

    Objective To evaluate individual and group long-term efficacy and safety of erenumab in individuals with Episodic Migraine (EM) for whom 2–4 prior preventatives had failed. Methods Participants completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study could continue into an open-label extension phase (OLEP) receiving erenumab 140 mg monthly for up to 3 years. Main outcomes assessed at week 112 were: ≥50%, ≥75% and 100% reduction in monthly Migraine days (MMD) as group responder rate and individual responder rates, MMD change from baseline, safety and tolerability. Results Overall 240/246 (97.6%) entered the OLEP (118 continuing erenumab, 122 switching from placebo). In total 181/240 (75.4%) reached 112 weeks, 24.6% discontinued, mainly due to lack of efficacy (44.0%), participant decision (37.0%) and adverse events (AEs; 12.0%). The ≥50% responder rate was 57.2% (99/173) at 112 weeks. Of ≥50% responders at the end of the DBTP, 36/52 (69.2%) remained responders at ≥50% and 22/52 (42.3%) at >80% of visits. Of the non-responders at the end of the DBTP, 60/185 (32.4%) converted to ≥50% responders in at least half the visits and 24/185 (13.0%) converted to ≥50% responders in >80% of visits. Change from baseline at 112 weeks in mean (SD) MMD was −4.2 (5.0) days. Common AEs (≥10%) were nasopharyngitis, influenza and back pain. Conclusions Efficacy was sustained over 112 weeks in individuals with difficult-to-treat EM for whom 2–4 prior Migraine preventives had failed. Erenumab treatment was safe and well tolerated, in-line with previous studies. Trial registration number NCT03096834

  • role of monoclonal antibodies against calcitonin gene related peptide cgrp in Episodic Migraine prevention where do we stand today
    Neurology India, 2021
    Co-Authors: Karthik Nagaraj, Nicolas Vandenbussche, Peter J Goadsby
    Abstract:

    Background: Medications targeting the calcitonin gene-related peptide (CGRP) pathway are exciting and novel therapeutic options in the treatment of Migraine. Objective: In this article, we have reviewed the role of these CGRP monoclonal antibodies in patients with Episodic Migraine. Materials and Methods: We did an extensive literature search for all phase 2 and 3 studies involving CGRP monoclonal antibodies in Episodic Migraine. Results: Erenumab, fremanezumab, galcanezumab, and eptinezumab have all undergone phase 3 trials and have been found to be effective for Episodic and chronic Migraine. They have the advantage of being targeted therapies for Migraine with very favorable adverse effect profiles comparable to placebo. Importantly, they are effective in subgroups of patients who have failed previous preventive therapies. Conclusion: Increasing use of these medications will certainly revolutionize the treatment and outlook for patients with Migraine all over the world.

  • one year sustained efficacy of erenumab in Episodic Migraine results of the strive study
    Neurology, 2020
    Co-Authors: Peter J Goadsby, Uwe Reuter, Yngve Hallstrom, Gregor Broessner, Jo H Bonner, Feng Zhang, Ian Wright, Denise E Chou, Jan Klatt, Hernan Picard
    Abstract:

    Objective To assess efficacy and tolerability of 1-year erenumab treatment in patients with Episodic Migraine. Methods Patients were randomized (n = 955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo or erenumab 70 or 140 mg. At week 24, 845 patients were rerandomized (1:1) to erenumab 70 or 140 mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly Migraine days (MMD), achieving ≥50%, ≥75%, and 100% reduction in MMD, and safety/tolerability were assessed. Results Mean MMD at DBTP baseline was 8.3. At week 52, mean changes (SE) from pre-DBTP baseline/week 24 (pre-ATP baseline) in MMD were −4.2 (0.2)/−1.1 (0.2) (70 mg) and −4.6 (0.2)/−1.8 (0.2) (140 mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70 mg (ATP), change in MMD from week 24 to 52 was −0.1 (0.3), and for those increasing from 70 (DBTP) to 140 mg (ATP), −1.8 (0.3). At week 52, 61.0%, 38.5%, and 19.8% of patients on erenumab 70 mg, and 64.9%, 40.8%, and 21.2% on erenumab 140 mg, achieved ≥50%, ≥75%, and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in ATP was similar to DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose. Conclusion Over 52 weeks, erenumab provided sustained efficacy in Episodic Migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding. Clinicaltrials.gov identifier NCT02456740. Classification of evidence Class II evidence that 52 weeks of treatment with erenumab 70 and 140 mg subcutaneously monthly results in sustained reductions in monthly Migraine days and similar dose tolerability for patients with Episodic Migraine.

  • guidelines of the international headache society for controlled trials of preventive treatment of Migraine attacks in Episodic Migraine in adults
    Cephalalgia, 2020
    Co-Authors: Hanschristoph Diener, Richard B. Lipton, Werner J Becker, David W Dodick, Messoud Ashina, Cristina Tassorelli, Stephan D Silberstein, Michel D Ferrari, Peter J Goadsby
    Abstract:

    Clinical trials are a key component of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Migraine. Advances in drugs, devices, and biologicals, as well as novel trial designs, have prompted several updates over the nearly 30 years since, including most recently the Guidelines for controlled trials of preventive treatment of chronic Migraine (2018), the Guidelines for controlled trials of acute treatment of Migraine attacks in adults (2019), and Guidelines for controlled trials of preventive treatment of Migraine in children and adolescents (2019). The present update incorporates findings from new research and is intended to optimize the design of controlled trials of preventive pharmacological treatment of Episodic Migraine in adults. A guideline for clinical trials with devices will be published separately.

  • efficacy of galcanezumab in patients with Episodic Migraine and a history of preventive treatment failure results from two global randomized clinical trials
    European Journal of Neurology, 2020
    Co-Authors: Dustin D Ruff, Sheena K Aurora, Janet H Ford, Antje Tockhornheidenreich, Virginia L Stauffer, Sriram Govindan, Gisela M Terwindt, Peter J Goadsby
    Abstract:

    BACKGROUND AND PURPOSE The efficacy of galcanezumab, a monoclonal antibody for Migraine prevention, has been demonstrated in two pivotal trials in patients with Episodic Migraine. METHODS EVOLVE-1 and EVOLVE-2 were identical phase 3, randomized, double-blind, placebo-controlled studies in patients with Episodic Migraine. Mean Migraine headache days per month at baseline was 9. Patients were randomized 2:1:1 to monthly injections of placebo, galcanezumab 120 mg/240 mg during the 6-month double-blind treatment period. Key efficacy outcomes were assessed in subgroups amongst patients for whom, previously, for efficacy and/or safety/tolerability reasons (i) one or more (≥1) preventives failed, (ii) two or more (≥2) preventives failed and (iii) preventives were never used, or used but not failed (no prior failure). RESULTS In an integrated analysis of EVOLVE studies, galcanezumab 120 mg/240 mg versus placebo led to larger overall mean (SE) reductions in monthly Migraine headache days across 6 months in patients with prior preventive failures (P < 0.001): ≥1 failure: 120 mg: -4.0 (0.4); 240 mg: -4.2 (0.5); placebo: -1.3 (0.4); ≥2 failures: 120 mg: -3.1 (0.7); 240 mg: -3.8 (0.8); placebo: -0.5 (0.6). Similar results were observed amongst patients with no prior failure, but the placebo response was larger: 120 mg: -4.7 (0.2); 240 mg: -4.5 (0.2); placebo: -3.0 (0.2) (P < 0.001 versus placebo). Significant improvements were observed with galcanezumab versus placebo for ≥50% and ≥75% reduction in monthly Migraine headache days. CONCLUSION In patients with Episodic Migraine treated with galcanezumab, those with ≥1 or ≥2 prior preventive failures had significantly larger improvements, versus placebo, in efficacy outcomes. Similar results were observed in patients with no prior failure, with a larger placebo response.

Alan M Rapoport - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and safety of dfn 11 sumatriptan injection 3 mg in adults with Episodic Migraine a multicenter randomized double blind placebo controlled study
    Journal of Headache and Pain, 2018
    Co-Authors: Stephen Landy, Sagar Munjal, Elimor Brandschieber, Alan M Rapoport
    Abstract:

    In a previous randomized, double-blind, proof-of-concept study in rapidly escalating Migraine, a 3 mg dose of subcutaneous sumatriptan (DFN-11) was associated with fewer and shorter triptan sensations than a 6 mg dose. The primary objective of the study was to assess the efficacy and safety of acute treatment with DFN-11 compared with placebo in Episodic Migraine. This was a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of DFN-11 in the acute treatment of adults with Episodic Migraine (study RESTOR). The primary endpoint was the proportion of subjects taking DFN-11 who were pain free at 2 h postdose in the double-blind period compared with placebo. Secondary endpoints included earlier postdose timepoints, assessments of pain relief and subjects’ freedom from their most bothersome symptom (MBS) (among nausea, photophobia, and phonophobia). Safety and tolerability were assessed. A total of 392 subjects was screened, 268 (68.4%) were randomized, and 234 (87.3% of those randomized) completed the double-blind treatment period. The proportion of subjects who were pain free at 2 h postdose was significantly greater in the DFN-11 group than in the placebo group (51.0% vs 30.8%, P  =  0.0023). Compared with placebo, significantly higher proportions of subjects treated with DFN-11 were also pain free at 30, 60, and 90 min postdose (P  ≤  0.0195). DFN-11 was significantly superior to placebo for pain relief at 60 min, 90 min, and 2 h postdose (P ≤ 0.0179). At 2 h postdose, DFN-11 was also significantly superior to placebo for freedom from photophobia (P  =  0.0056) and phonophobia (P  =  0.0167). Overall, 33.3% (37/111) who received DFN-11 and 13.4% (16/119) who received placebo experienced at least 1 treatment-emergent adverse event (TEAE), the most common of which were injection site swelling (7.2% vs 0.8%) and pain (7.2% vs 5.9%). Chest discomfort was about half as common in the DFN-11 treatment group as it was in the placebo group (0.9% vs 1.7%). This study met its primary endpoint, pain freedom at 2 h postdose, with DFN-11 significantly better than placebo, and the incidence of TEAEs and triptan sensations with DFN-11 was low. The 3 mg dose of sumatriptan in DFN-11 appears to be an effective alternative to a 6 mg SC dose of sumatriptan, with good safety and tolerability. ( clinicaltrials.gov : NCT02569853; registered 07 October 2015).

  • Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with Episodic Migraine: a multicenter, randomized, double-blind, placebo-controlled study
    BMC, 2018
    Co-Authors: Stephen Landy, Sagar Munjal, Elimor Brand-schieber, Alan M Rapoport
    Abstract:

    Abstract Background In a previous randomized, double-blind, proof-of-concept study in rapidly escalating Migraine, a 3 mg dose of subcutaneous sumatriptan (DFN-11) was associated with fewer and shorter triptan sensations than a 6 mg dose. The primary objective of the study was to assess the efficacy and safety of acute treatment with DFN-11 compared with placebo in Episodic Migraine. Methods This was a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of DFN-11 in the acute treatment of adults with Episodic Migraine (study RESTOR). The primary endpoint was the proportion of subjects taking DFN-11 who were pain free at 2 h postdose in the double-blind period compared with placebo. Secondary endpoints included earlier postdose timepoints, assessments of pain relief and subjects’ freedom from their most bothersome symptom (MBS) (among nausea, photophobia, and phonophobia). Safety and tolerability were assessed. Results A total of 392 subjects was screened, 268 (68.4%) were randomized, and 234 (87.3% of those randomized) completed the double-blind treatment period. The proportion of subjects who were pain free at 2 h postdose was significantly greater in the DFN-11 group than in the placebo group (51.0% vs 30.8%, P  =  0.0023). Compared with placebo, significantly higher proportions of subjects treated with DFN-11 were also pain free at 30, 60, and 90 min postdose (P  ≤  0.0195). DFN-11 was significantly superior to placebo for pain relief at 60 min, 90 min, and 2 h postdose (P ≤ 0.0179). At 2 h postdose, DFN-11 was also significantly superior to placebo for freedom from photophobia (P  =  0.0056) and phonophobia (P  =  0.0167). Overall, 33.3% (37/111) who received DFN-11 and 13.4% (16/119) who received placebo experienced at least 1 treatment-emergent adverse event (TEAE), the most common of which were injection site swelling (7.2% vs 0.8%) and pain (7.2% vs 5.9%). Chest discomfort was about half as common in the DFN-11 treatment group as it was in the placebo group (0.9% vs 1.7%). Conclusions This study met its primary endpoint, pain freedom at 2 h postdose, with DFN-11 significantly better than placebo, and the incidence of TEAEs and triptan sensations with DFN-11 was low. The 3 mg dose of sumatriptan in DFN-11 appears to be an effective alternative to a 6 mg SC dose of sumatriptan, with good safety and tolerability. (clinicaltrials.gov: NCT02569853; registered 07 October 2015)

  • a multicenter open label long term safety and tolerability study of dfn 02 an intranasal spray of sumatriptan 10 mg plus permeation enhancer ddm for the acute treatment of Episodic Migraine
    Journal of Headache and Pain, 2017
    Co-Authors: Sagar Munjal, Elimor Brandschieber, Kent Allenby, Egilius L H Spierings, Roger K Cady, Alan M Rapoport
    Abstract:

    DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeation-enhancing excipient comprised of 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM). This composition of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation and exhibit pharmacokinetics comparable to subcutaneously administered sumatriptan. Rapid rate of absorption is suggested to be important for optimal efficacy. The objective of this study was to evaluate the safety and tolerability of DFN-02 (10 mg) in the acute treatment of Episodic Migraine with and without aura over a 6-month period based on the incidence of treatment-emergent adverse events and the evaluation of results of clinical laboratory tests, vital signs, physical examination, and electrocardiograms. This was a multi-center, open-label, repeat-dose safety study in adults with Episodic Migraine with and without aura. Subjects diagnosed with Migraine with or without aura according to the criteria set forth in the International Classification of Headache Disorders, 2nd edition, who experienced 2 to 6 attacks per month with fewer than 15 headache days per month and at least 48 headache-free hours between attacks, used DFN-02 to treat their Migraine attacks acutely over the course of 6 months. A total of 173 subjects was enrolled, 167 (96.5%) subjects used at least 1 dose of study medication and were evaluable for safety, and 134 (77.5%) subjects completed the 6-month study. A total of 2211 Migraine attacks was reported, and 3292 doses of DFN-02 were administered; mean per subject monthly use of DFN-02 was 3.6 doses. Adverse events were those expected for triptans, as well as for nasally administered compounds. No new safety signals emerged. Dysgeusia and application site pain were the most commonly reported treatment-emergent adverse events over 6 months (21% and 30.5%, respectively). Most of the treatment-emergent adverse events were mild. There were 5 serious adverse events, all considered unrelated to the study medication; the early discontinuation rate was 22.5% over the 6-month treatment period. DFN-02 was shown to be well tolerated when used over 6 months to treat Episodic Migraine acutely.

  • safety tolerability and efficacy of tev 48125 for preventive treatment of high frequency Episodic Migraine a multicentre randomised double blind placebo controlled phase 2b study
    Lancet Neurology, 2015
    Co-Authors: Marcelo E. Bigal, Rami Burstein, Alan M Rapoport, David W Dodick, Stephen D Silberstein, Ronghua Yang, Pippa S Loupe, Lawrence C Newman, Richard B. Lipton
    Abstract:

    Summary Background Calcitonin gene-related peptide (CGRP) is a validated target for the treatment of Episodic Migraine. Here we assess the safety, tolerability, and efficacy of TEV-48125, a monoclonal anti-CGRP antibody, in the preventive treatment of high-frequency Episodic Migraine. Methods In this multicentre, randomised, double-blind, placebo-controlled, phase 2b study, we enrolled men and women (aged 18–65 years) from 62 sites in the USA who had Migraine headaches 8–14 days per month. Using a randomisation list generated by a central computerised system and an interactive web response system, we randomly assigned patients (1:1:1; stratified by sex and use of concomitant preventive drugs) after a 28 day run-in period to three 28 day treatment cycles of subcutaneous 225 mg TEV-48125, 675 mg TEV-48125, or placebo. Investigators, patients, and the funder were blinded to treatment allocation. Patients reported headache information daily using an electronic diary. Primary endpoints were change from baseline in Migraine days during the third treatment cycle (weeks 9–12) and safety and tolerability. The secondary endpoint was change relative to baseline in headache-days during weeks 9–12. Efficacy endpoints were analysed for the intention-to-treat population. Safety and tolerability were analysed using descriptive statistics. This trial is registered at ClinicalTrials.gov, number NCT02025556. Findings Between Jan 8, 2014, and Oct 15, 2014, we enrolled 297 participants: 104 were randomly assigned to receive placebo, 95 to receive 225 mg TEV-48125, and 96 to receive 675 mg TEV-48125. The least square mean (LSM) change in number of Migraine-days from baseline to weeks 9–12 was −3·46 days (SD 5·40) in the placebo group, −6·27 days (5·38) in the 225 mg dose group, and −6·09 days (5·22) in the 675 mg dose group. The LSM difference in the reduction of Migraine-days between the placebo and 225 mg dose groups was −2·81 days (95% CI −4·07 to −1·55; p Interpretation TEV-48125, at doses of 225 mg and 675 mg given once every 28 days for 12 weeks, was safe, well tolerated, and effective as a preventive treatment of high-frequency Episodic Migraine, thus supporting advancement of the clinical development programme to phase 3 clinical trials. Funding Teva Pharmaceuticals.

  • assessment of Migraine disability using the Migraine disability assessment midas questionnaire a comparison of chronic Migraine with Episodic Migraine
    Headache, 2003
    Co-Authors: Marcelo E. Bigal, Richard B. Lipton, Alan M Rapoport, Stewart J Tepper, Fred D Sheftell
    Abstract:

    Background.—Chronic Migraine is the most common type of chronic daily headache seen in headache tertiary care centers. Most patients with chronic Migraine report their ability to function and feeling of well-being as severely impaired. Objective.—To measure the headache-related disability of patients with chronic Migraine using the Migraine Disability Assessment (MIDAS) Questionnaire, comparing it with that obtained in a control group of patients with Episodic Migraine. Methods.—The clinical records of 703 patients with chronic daily headache treated in a headache specialty clinic were reviewed to identify 182 with chronic Migraine who were evaluated using the MIDAS at their initial visit. Our control group consisted of 86 patients with Episodic Migraine. Results.—Of the 182 patients with chronic Migraine, 127 (69.8%) were overusing acute-care medication. Patients were predominantly women (72.5%), with a mean age of 38.3 years. The group with Episodic Migraine consisted of 59 women (68.6%), with a mean age of 36.1 years. No statistically significant demographic differences were observed between the two groups. The group with chronic Migraine had more total headache days over 3 months (66.7 versus 15.5, P<.001), missed more days of work or school (5.3 versus 2.3, P  =  .0007), had more reduced effectiveness days at work or school (11.9 versus 4.6, P  =  .0001), missed more days of housework (16.5 versus 3.3, P<.0001), and missed more days of family, social, or leisure activities (7.0 versus 5.5, P  =  .03). The group with chronic Migraine was more likely to be in MIDAS grade IV (64.3% versus 43.2%, P  =  .001), reflecting the great likelihood of severe disability in this group. The average total MIDAS score was 34.9 in the group with chronic Migraine versus 19.3 in the group with Episodic Migraine (P<.001). Conclusion.—In subspecialty centers, patients with chronic Migraine demonstrate remarkable impairment of their daily activities and are severely burdened by their headache syndrome, reflected by their high MIDAS scores. The chronicity and pervasiveness of Migraine thus is associated with increased functional impairment as well as increase in headache frequency.

David W Dodick - One of the best experts on this subject based on the ideXlab platform.

  • reversion from chronic Migraine to Episodic Migraine following treatment with erenumab results of a post hoc analysis of a randomized 12 week double blind study and a 52 week open label extension
    Cephalalgia, 2021
    Co-Authors: R Lipton, David W Dodick, Stephen D Silberstein, Uwe Reuter, Feng Zhang, Stewart J Tepper, Messoud Ashina, David Kudrow, Gregory A Rippon, Sunfa Cheng
    Abstract:

    ObjectiveTo determine reversion rates from chronic Migraine to Episodic Migraine during long-term erenumab treatment.MethodsA daily headache diary was completed during the 12-week, double-blind tre...

  • guidelines of the international headache society for controlled trials of preventive treatment of Migraine attacks in Episodic Migraine in adults
    Cephalalgia, 2020
    Co-Authors: Hanschristoph Diener, Richard B. Lipton, Werner J Becker, David W Dodick, Messoud Ashina, Cristina Tassorelli, Stephan D Silberstein, Michel D Ferrari, Peter J Goadsby
    Abstract:

    Clinical trials are a key component of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Migraine. Advances in drugs, devices, and biologicals, as well as novel trial designs, have prompted several updates over the nearly 30 years since, including most recently the Guidelines for controlled trials of preventive treatment of chronic Migraine (2018), the Guidelines for controlled trials of acute treatment of Migraine attacks in adults (2019), and Guidelines for controlled trials of preventive treatment of Migraine in children and adolescents (2019). The present update incorporates findings from new research and is intended to optimize the design of controlled trials of preventive pharmacological treatment of Episodic Migraine in adults. A guideline for clinical trials with devices will be published separately.

  • rapid onset of effect of galcanezumab for the prevention of Episodic Migraine analysis of the evolve studies
    Headache, 2020
    Co-Authors: Holland C Detke, David W Dodick, Brian A Millen, Qi Zhang, Karen Samaan, Jessica Ailani, Sheena K Aurora
    Abstract:

    OBJECTIVE To evaluate onset of effect of galcanezumab in patients with Episodic Migraine. BACKGROUND Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of Migraine. DESIGN/METHODS Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with Episodic Migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly Migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs. RESULTS For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P < .001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P < .001) and each subsequent week compared with placebo-treated patients (P ≤ .004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P < .001], and for EVOLVE-2, 59.4% vs 38.0% [P < .001]). CONCLUSION Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of Episodic Migraine.

  • onset of efficacy and duration of response of galcanezumab for the prevention of Episodic Migraine a post hoc analysis
    Journal of Neurology Neurosurgery and Psychiatry, 2019
    Co-Authors: Peter J Goadsby, David W Dodick, Qi Zhang, Vladimir Skljarevski, Tina M Oakes, Margaret B Ferguson, James M Martinez, Sheena K Aurora
    Abstract:

    Background and objective As new Migraine prevention treatments are developed, the onset of a preventive effect, how long it is maintained and whether patients initially non-responsive develop clinically meaningful responses with continued treatment can be assessed. Methods Analyses were conducted post-hoc of a double-blind, placebo-controlled, phase II-a study in patients with Episodic Migraine receiving galcanezumab 150 mg or placebo biweekly for 12 weeks (Lancet Neurol 13:885, 2014). The number of Migraine headache days per week, and onset of efficacy measured as the first week galacanezumab separated from placebo were determined. Patients with ≥50%, ≥75% and 100% reduction in Migraine headache days from baseline at months 1, 2 and 3 were calculated and defined as sustained responses. Non-responders ( Results Patients were randomised to galcanezumab (n=107) or placebo (n=110). A significant (p=0.018) change of −0.89±0.11 (galcanezumab) vs −0.53±0.11 (placebo) Migraine headache days indicated onset at week 1. Forty-seven per cent of galcanezumab and 25% of placebo patients responding at month 1 maintained response through months 2 and 3. Of non-responders at month 1, 27% on galcanezumab and 20% on placebo responded on months 2 and 3, and 50% of galcanezumab non-responders in months 1 and 2 responded on month 3, vs 24% on placebo. Conclusions The onset of efficacy of galcanezumab is within 1 week in a majority of patients, and patients receiving galcanezumab are twice more likely to maintain responses than placebo patients. Early non-responders may respond by month 2 or month 3. Trial registration number NCT01625988.

  • evaluation of galcanezumab for the prevention of Episodic Migraine the evolve 1 randomized clinical trial
    JAMA Neurology, 2018
    Co-Authors: Virginia L Stauffer, David W Dodick, Qi Zhang, Jessica Ailani, Jeffrey N Carter, Robert R Conley
    Abstract:

    Importance Migraine is a disabling neurological disease characterized by severe headache attacks. Treatment options reduce Migraine frequency for many patients, but adverse effects lead to discontinuation in many patients. Objective To demonstrate that galcanezumab is superior to placebo in the prevention of Episodic Migraine with or without aura. Design, Setting, and Participants The EVOLVE-1 (Evaluation of LY2951742 in the Prevention of Episodic Migraine 1) trial was a double-blind, randomized, placebo-controlled (January 11, 2016, to March 22, 2017) trial comparing galcanezumab (120 mg and 240 mg) vs placebo. Patients received treatments once monthly for 6 months (subcutaneous injection via prefilled syringe) and were followed up for 5 months after their last injection. It was a multicenter, clinic-based study involving 90 sites in North America. Participants in the study were adults (aged 18 to 65 years) with at least a 1-year history of Migraine, 4 to 14 Migraine headache days per month and a mean of at least 2 Migraine attacks per month within the past 3 months, and were diagnosed prior to age 50 years. During the study, no other preventive medications were allowed. A total of 1671 patients were assessed; 809 did not meet study entry or baseline criteria, and 858 were included in the intent-to-treat population. Interventions Patients were randomized (2:1:1) to monthly placebo, galcanezumab, 120 mg, and galcanezumab, 240 mg. Main Outcomes and Measures The primary outcome was overall mean change from baseline in the number of monthly Migraine headache days during the treatment period. Secondary measures included at least 50%, at least 75%, and 100% reduction in monthly Migraine headache days, Migraine headache days with acute medication use, and scores from the Migraine-Specific Quality of Life questionnaire, Patient Global Impression of Severity, and Migraine Disability Assessment. Treatment-emergent adverse events and serious adverse events were reported. Results Of the 1671 patients assessed, 858 (mean age, 40.7 years; 718 women [83.7%]) met study entry criteria and received at least 1 dose of investigational product. The primary objective was met for both galcanezumab doses; treatment with galcanezumab significantly reduced monthly Migraine headache days (bothP  Conclusions and Relevance Galcanezumab 120-mg and 240-mg monthly injections provided clinical benefits and improved functioning. The incidence rate of adverse events was low, demonstrating the favorable tolerability profile of galcanezumab. Trial Registration ClinicalTrials.gov Identifier:NCT02614183

Richard B. Lipton - One of the best experts on this subject based on the ideXlab platform.

  • guidelines of the international headache society for controlled trials of preventive treatment of Migraine attacks in Episodic Migraine in adults
    Cephalalgia, 2020
    Co-Authors: Hanschristoph Diener, Richard B. Lipton, Werner J Becker, David W Dodick, Messoud Ashina, Cristina Tassorelli, Stephan D Silberstein, Michel D Ferrari, Peter J Goadsby
    Abstract:

    Clinical trials are a key component of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Migraine. Advances in drugs, devices, and biologicals, as well as novel trial designs, have prompted several updates over the nearly 30 years since, including most recently the Guidelines for controlled trials of preventive treatment of chronic Migraine (2018), the Guidelines for controlled trials of acute treatment of Migraine attacks in adults (2019), and Guidelines for controlled trials of preventive treatment of Migraine in children and adolescents (2019). The present update incorporates findings from new research and is intended to optimize the design of controlled trials of preventive pharmacological treatment of Episodic Migraine in adults. A guideline for clinical trials with devices will be published separately.

  • cardiovascular events conditions and procedures among people with Episodic Migraine in the us population results from the american Migraine prevalence and prevention ampp study
    Headache, 2017
    Co-Authors: Dawn C Buse, Michael L Reed, Kristina M Fanning, Tobias Kurth, Richard B. Lipton
    Abstract:

    Background Though Migraine, particularly Migraine with aura, is a cardiovascular (CV) risk factor, the scope and distribution of cardiovascular disease in representative samples of people with Migraine are not known. This is important because many widely used acute Migraine treatments, including triptans, ergot alkaloids, and nonsteroidal anti-inflammatory drugs, carry precautions, warnings, or contraindications for use in persons with CV disease. Objectives To assess the scope and distribution of cardiovascular events, conditions, and procedures in persons with Episodic Migraine in a representative sample of the US population, using data from the American Migraine Prevalence and Prevention (AMPP) Study. Methods Eligible subjects completed the 2009 AMPP survey, met ICHD-3beta criteria for Migraine, and had a headache frequency of less than 15 days per month (Episodic Migraine). A survey on cardiovascular events (ie, myocardial infarction), conditions (ie, angina), and procedures (ie, carotid endarterectomy) was adopted from the Women's Health Study and the Physician's Health Studies. Cardiovascular events and conditions were defined by participant reports of having both experienced and received a physician diagnosis for a particular event or condition. The distribution of CV events, conditions, and procedures was summarized for the entire Migraine sample and in groups defined by gender and age (22–39, 40-59, and ≥60). To assess the numbers of persons with Episodic Migraine in the US, we applied age and gender stratified estimates of Migraine prevalence to the 2015 Census data. To estimate the number of cardiovascular events, conditions, and procedures in the US Migraine population, we applied age and gender stratified event rates to the number of persons with Episodic Migraine in each stratum. Results The 2009 AMPP Study survey was returned by 11,792 study participants out of 16,983 (64.9% response rate), including 6723 individuals who met study criteria for Episodic Migraine (5227 women and 1496 men). Among 22-39 year olds with Episodic Migraine, 3.4% reported having received a physician diagnosis of CV events or conditions and 1.1% reported undergoing CV related procedures. Among 40-59 year olds, 10.2% reported having received a physician diagnosis of CV events or conditions and 3.5% reported CV related procedures. For those age 60 or older, 22.3% reported CV events or conditions and 8.8% reported CV procedures. Prevalence of events, conditions, and procedures was higher in men than women and also in older age groups. However, the absolute number of CV events, procedures, and conditions was greater for women than men due to the higher population prevalence of Episodic Migraine in women. We projected that 2.0 million women and 665,000 men in the US had Episodic Migraine and a history of one or more CV event, condition, or procedure. By age group, it is estimated that 579,000 among those aged 22-39, 1.37 million of those aged 40-59, and 696,000 of those 60 and older with Episodic Migraine have ever had at least one CV event, procedure, or condition. Conclusion Based on these analyses, we estimate that there are roughly 2.6 million people with Episodic Migraine aged 22 and older in the US with one or more prior CV event, condition, or procedure. For this group, cardiovascular contraindications to many Migraine-specific acute Migraine therapies may make treatment challenging.

  • safety tolerability and efficacy of tev 48125 for preventive treatment of high frequency Episodic Migraine a multicentre randomised double blind placebo controlled phase 2b study
    Lancet Neurology, 2015
    Co-Authors: Marcelo E. Bigal, Rami Burstein, Alan M Rapoport, David W Dodick, Stephen D Silberstein, Ronghua Yang, Pippa S Loupe, Lawrence C Newman, Richard B. Lipton
    Abstract:

    Summary Background Calcitonin gene-related peptide (CGRP) is a validated target for the treatment of Episodic Migraine. Here we assess the safety, tolerability, and efficacy of TEV-48125, a monoclonal anti-CGRP antibody, in the preventive treatment of high-frequency Episodic Migraine. Methods In this multicentre, randomised, double-blind, placebo-controlled, phase 2b study, we enrolled men and women (aged 18–65 years) from 62 sites in the USA who had Migraine headaches 8–14 days per month. Using a randomisation list generated by a central computerised system and an interactive web response system, we randomly assigned patients (1:1:1; stratified by sex and use of concomitant preventive drugs) after a 28 day run-in period to three 28 day treatment cycles of subcutaneous 225 mg TEV-48125, 675 mg TEV-48125, or placebo. Investigators, patients, and the funder were blinded to treatment allocation. Patients reported headache information daily using an electronic diary. Primary endpoints were change from baseline in Migraine days during the third treatment cycle (weeks 9–12) and safety and tolerability. The secondary endpoint was change relative to baseline in headache-days during weeks 9–12. Efficacy endpoints were analysed for the intention-to-treat population. Safety and tolerability were analysed using descriptive statistics. This trial is registered at ClinicalTrials.gov, number NCT02025556. Findings Between Jan 8, 2014, and Oct 15, 2014, we enrolled 297 participants: 104 were randomly assigned to receive placebo, 95 to receive 225 mg TEV-48125, and 96 to receive 675 mg TEV-48125. The least square mean (LSM) change in number of Migraine-days from baseline to weeks 9–12 was −3·46 days (SD 5·40) in the placebo group, −6·27 days (5·38) in the 225 mg dose group, and −6·09 days (5·22) in the 675 mg dose group. The LSM difference in the reduction of Migraine-days between the placebo and 225 mg dose groups was −2·81 days (95% CI −4·07 to −1·55; p Interpretation TEV-48125, at doses of 225 mg and 675 mg given once every 28 days for 12 weeks, was safe, well tolerated, and effective as a preventive treatment of high-frequency Episodic Migraine, thus supporting advancement of the clinical development programme to phase 3 clinical trials. Funding Teva Pharmaceuticals.

  • ineffective acute treatment of Episodic Migraine is associated with new onset chronic Migraine
    Neurology, 2015
    Co-Authors: Richard B. Lipton, Daniel Serrano, Michael L Reed, Kristina M Fanning, Roger K Cady, Dawn C Buse
    Abstract:

    Objective: To test the hypothesis that ineffective acute treatment of Episodic Migraine (EM) is associated with an increased risk for the subsequent onset of chronic Migraine (CM). Methods: In the American Migraine Prevalence and Prevention Study, respondents with EM in 2006 who completed the Migraine Treatment Optimization Questionnaire (mTOQ-4) and provided outcome data in 2007 were eligible for analyses. The mTOQ-4 is a validated questionnaire that assesses treatment efficacy based on 4 aspects of response to acute treatment. Total mTOQ-4 scores were used to define categories of acute treatment response: very poor, poor, moderate, and maximum treatment efficacy. Logistic regression models were used to examine the dichotomous outcome of transition from EM in 2006 to CM in 2007 as a function of mTOQ-4 category, adjusting for covariates. Results: Among 5,681 eligible study respondents with EM in 2006, 3.1% progressed to CM in 2007. Only 1.9% of the group with maximum treatment efficacy developed CM. Rates of new-onset CM increased in the moderate treatment efficacy (2.7%), poor treatment efficacy (4.4%), and very poor treatment efficacy (6.8%) groups. In the fully adjusted model, the very poor treatment efficacy group had a more than 2-fold increased risk of new-onset CM (odds ratio = 2.55, 95% confidence interval 1.42–4.61) compared to the maximum treatment efficacy group. Conclusion: Inadequate acute treatment efficacy was associated with an increased risk of new-onset CM over the course of 1 year. Improving acute treatment outcomes might prevent new-onset CM, although reverse causality cannot be excluded.

  • examination of unmet treatment needs among persons with Episodic Migraine results of the american Migraine prevalence and prevention ampp study
    Headache, 2013
    Co-Authors: Dawn C Buse, Daniel Serrano, Richard B. Lipton, Starr Holland, Michael L Reed
    Abstract:

    Background Despite the expanding therapeutic armamentarium, many people with Episodic Migraine (EM) have unmet acute treatment needs. Objective To determine the relative frequency of prespecified types of “unmet treatment needs” in persons with EM in a US population-based sample. Methods Eligible participants completed the 2009 American Migraine Prevalence and Prevention Study survey and met International Classification of Headache Disorders-2nd edition (ICHD-2) criteria for Migraine with an average headache day frequency of <15 days per month (EM). We identified 5 domains of unmet treatment needs: (1) dissatisfaction with current acute treatment using 3 summary items from the Patient Perception of Migraine Questionnaire-revised edition (PPMQ-R); (2) moderate or severe headache-related disability defined by a Migraine Disability Assessment Scale score of ≥11; (3) excessive use of opioids or barbiturates defined as use on ≥4 days/month or by meeting Diagnostic and Statistical Manual for Mental Disorders-4th edition criteria for dependence; (4) recurrent use of the emergency department or urgent care clinic for headache defined by ≥2 visits in the preceding year for headache; and (5) history of cardiovascular events indicating a possible contraindication to triptan use. For each respondent, we identified their unmet treatment needs in each category and classified them as having no unmet needs or 1 or more unmet needs. Results Of 5591 respondents with EM, 2274 (40.7%) had 1 or more unmet needs; 1467 (26.2%) had exactly 1 unmet need, and 807 (14.4%) had 2 or more unmet needs. Among those with at least 1 unmet need, 1069 (47.0%) had moderate or severe headache-related disability, 851 (37.4%) were dissatisfied with their acute treatment regimen, 728 (32.0%) had excessive opioid or barbiturate use and/or probable dependence, 595 (26.2%) had a history of cardiovascular events, and 129 (5.7%) reported ≥2 visits in the preceding year to the emergency department/urgent care clinic for headache. Persons with more headache days, depression, or generalized anxiety were more likely to have unmet treatment needs. Conclusion In a population sample of individuals with EM, more than 40% have at least 1 unmet need in the area of acute treatment. The leading reasons for unmet needs, which include headache-related disability and dissatisfaction with current acute treatment, suggest opportunities for improving outcomes for persons with EM.

Suzanne M Bertisch - One of the best experts on this subject based on the ideXlab platform.

  • napping behavior in adults with Episodic Migraine a six week prospective cohort study
    Sleep, 2021
    Co-Authors: Elizabeth Mostofsky, Suzanne M Bertisch, Angeliki Vgontzas, Michael Rueschman, Murray A Mittleman, Kobina Hagan
    Abstract:

    STUDY OBJECTIVES Patients with Migraine commonly endorse napping as a strategy for headache pain relief, but also experience high rates of sleep disturbance. To elucidate the relationship between napping behavior and Migraine, we evaluated the association between napping and headache frequency, severity, and intensity among adults with Episodic Migraine. We also examined the association between daily napping and that night's sleep. METHODS In this six-week prospective cohort study, 97 adults with Episodic Migraine completed twice-daily headache and sleep electronic diaries and wore a wrist actigraph. We modeled the associations between napping (yes/no) and headaches with conditional logistic regression and daily napping and nighttime sleep with linear regression. RESULTS Over 4,353 study days, participants reported 1,059 headache days and 389 days with naps. More than 80% of participants napped during the study, with mean nap duration of 76.7±62.4 minutes. Naps were more likely to occur on day 2 of headache 35/242 (14.5%) than on non-headache days 279/3294 (8.5%, OR 2.2 [95%CI 1.4,3.4]). Mean nap onset time (14:40h ± 3.3h) was later than headache onset (12:48h ± 5.3h). In adjusted models, napping was associated with an additional 1.1 (95%CI -1.4, 3.6) headache days/month. Naps were not associated with worse self-reported or objective sleep that night. CONCLUSIONS Our findings suggest that naps may be an uncommonly used behavioral strategy for prolonged Migraine attacks and do not contribute to nightly sleep disturbance. Future studies are needed to examine the acute analgesic effects of daytime napping in patients with Migraine.

  • baseline sleep quality stress and depressive symptoms and subsequent headache occurrence in a six week prospective cohort study of patients with Episodic Migraine
    Headache, 2021
    Co-Authors: Angeliki Vgontzas, Elizabeth Mostofsky, Murray A Mittleman, Suzanne M Bertisch
    Abstract:

    OBJECTIVES/BACKGROUND Despite the high prevalence of sleep disturbance, stress, and depressive symptoms among patients with Episodic Migraine, there has been limited prospective research examining how these comorbid symptoms relate to future headache risk. METHODS We conducted an a priori secondary analysis of a prospective cohort study of 98 adults with Episodic Migraine recruited through Harvard-affiliated medical centers and local college student clinics in Boston, MA. At baseline, participants completed validated questionnaires on sleep quality, stress, and depressive symptoms. Over the next 6 weeks, they recorded headaches on twice-daily diaries. We conducted time-to-event analyses to evaluate whether these baseline symptoms were associated with headache recurrence. RESULTS At baseline, 45/98 (46%) participants had poor sleep quality, 51/98 (52%) reported moderate/high stress levels, and 18/98 (18%) had high depressive symptom scores. Over 4,406 person-days, we observed 823 discrete headaches. In multivariable models, the hazard ratios for headache recurrence were: 1.22 (95% CI 1.02, 1.46) for people with baseline poor sleep, 1.12 (95% CI 0.93, 1.35) for those with baseline moderate/high stress compared to lower levels, and 1.31 (95% CI 1.05, 1.65) for the combination of poor sleep and moderate/high stress compared to the combination of good sleep and low stress. There was no association between depression scores and headache risk. CONCLUSION Among patients with Episodic Migraine, poor sleep was associated with a higher rate of headache recurrence over the next 6 weeks, especially among those with coexisting moderate/high stress.

  • prospective cohort study of routine exercise and headache outcomes among adults with Episodic Migraine
    Headache, 2021
    Co-Authors: Kobina Hagan, Elizabeth Mostofsky, Suzanne M Bertisch, Angeliki Vgontzas, Catherine Buettner, Murray A Mittleman
    Abstract:

    Objective To evaluate the association of routine exercise with headache frequency, intensity, and duration among adults with Episodic Migraine (EM). Background A comprehensive management plan for EM must aim at reducing disability and cost of care; to do so requires optimizing acute and preventive medications, and behavior changes. Prophylactic medication use is associated with adverse events and contraindications with comorbidities. Aerobic exercise is reported to decrease Migraine frequency. However, no study has evaluated a potential synergistic relation between regular exercise and preventive medication use among patients with EM. Design and methods This was a secondary analysis of data from a prospective cohort study of adults with EMs. In that study, adults with EM (using International Classification of Headache Disorders-3 criteria confirmed by study physicians) were recruited from three academic medical centers in Boston, MA. At baseline, participants provided information on exercise, clinical and demographic characteristics, and lifestyle behaviors. We prospectively collected daily information on headaches and health behavior over at least 6 weeks using electronic questionnaires from 94 participants. We assessed the association between baseline self-reported moderate-vigorous exercise at least three times per week, at baseline, and prospectively recorded headache frequency, intensity, and duration. We further assessed whether these associations differed by the prevalent use of prophylactic Migraine medication. Results Data from 94 of 98 eligible participants were used in the analysis as 4 participants had missing data on routine exercise frequency or intensity at baseline. On average, patients who reported moderate-vigorous exercise at least three times per week at enrollment had 1.5 fewer headache days per month (-1.5 headache days/month; 95% confidence interval [CI] -3.1 to 0.1) compared to less exercise; this was not statistically significant (p = 0.066). The association between exercise and headache days per month varied by baseline use of Migraine prophylaxis (p-value of interaction = 0.009). Among those who reported regular use of Migraine prophylaxis, a report of moderate-vigorous exercise at least three times per week was associated with 5.1 fewer headache days (-5.1: 95% CI -8.2 to -2.0; p = 0.001) compared to those who reported lower levels of exercise. However, among those not using Migraine prophylaxis, we observed only 0.4 fewer headache days per month (-0.4: 95% CI -2.2 to 1.3; p = 0.636) associated with moderate-vigorous exercise at least three times/week, a result that was not statistically significant. There was no association of self-reported moderate-vigorous exercise at least three times a week with headache intensity or duration. Conclusion In patients with EM, those who reported moderate-vigorous exercise at least three times per week had fewer headache days per month, though not statistically significant. This association was significantly stronger in those who used prophylactic medication for Migraines. Exercise appeared not to be associated with the severity or duration of headaches. Routine moderate-vigorous exercise may be an important adjunctive strategy for improving headache burden in patients eligible for Migraine prophylaxis.

  • associations between Migraine attacks and nightly sleep characteristics among adults with Episodic Migraine a prospective cohort study
    Sleep, 2020
    Co-Authors: Elizabeth Mostofsky, Suzanne M Bertisch, Angeliki Vgontzas, Michael Rueschman, Murray A Mittleman
    Abstract:

    STUDY OBJECTIVES Given the unknown immediate impact of Migraine on nighttime sleep, we prospectively examined whether Migraine headaches were associated with subsequent shorter sleep duration, higher fragmentation, and poorer quality in a cohort of 98 adults with Episodic Migraine. METHODS Participants completed twice-daily electronic diaries and wore actigraphs continuously for 6 weeks. We examined whether days with headaches were associated with changes in that night's sleep characteristics compared with headache-free days, using adjusted multivariable linear mixed models with subject-specific intercepts. RESULTS Participants were 35 ± 12 years old, 88% women, with an average of five Migraine headaches per month. Over 4,406 days, we observed 1,077 headache days, representing 823 discrete headaches. Average nightly objective sleep duration was 7.3 ± 1.2 hr, efficiency 89.5 ± 3.3%, and wake after sleep onset (WASO) 44.8 ± 17.0 min. Objective sleep duration was 7.3 min (95% CI: 1.5, 13.0) longer on nights following a headache day compared with nights on a headache-free day. Objective sleep efficiency, WASO, and reported sleep quality were not significantly different on headache days compared with headache-free days (sleep efficiency: -0.06 min, 95% CI: -0.3, 0.2; WASO 1.5 min, 95% CI: 0.0, 3.0; sleep quality: 1.0, 95% CI: 0.8, 1.3). CONCLUSIONS Sleep periods immediately following Migraine headaches are not associated with shorter duration, higher disruption, or poorer sleep quality in patients with Episodic Migraine. These results suggest that clinical evaluation of sleep disturbance in patients with Episodic Migraine should be approached independently of their Migraine status.

  • prospective cohort study of daily alcoholic beverage intake as a potential trigger of headaches among adults with Episodic Migraine
    Annals of Medicine, 2020
    Co-Authors: Elizabeth Mostofsky, Suzanne M Bertisch, Angeliki Vgontzas, Catherine Buettner, Michael Rueschman, Murray A Mittleman
    Abstract:

    Purpose: To determine whether alcohol intake is associated with occurrence of headaches on the following day.Methods: In this prospective cohort study, adults with Episodic Migraine completed elect...