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Lars Jacob Stovner - One of the best experts on this subject based on the ideXlab platform.
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Photophobia and Phonophobia in tension-type and cervicogenic headache.
Cephalalgia, 1998Co-Authors: J Vanagaite Vingen, Lars Jacob StovnerAbstract:Light and sound-induced discomfort and pain thresholds were measured in 26 patients with cervicogenic headache, in 40 patients with tension-type headache, and in 100 headache-free controls. Neither headache group was significantly different as to photophobia and Phonophobia, but both were significantly more sensitive to light and sound than controls (p 0.56). In cervicogenic headache patients, photophobia (p
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photophobia and Phonophobia in tension type and cervicogenic headache
Cephalalgia, 1998Co-Authors: Vanagaite J Vingen, Lars Jacob StovnerAbstract:Light and sound-induced discomfort and pain thresholds were measured in 26 patients with cervicogenic headache, in 40 patients with tension-type headache, and in 100 headache-free controls. Neither headache group was significantly different as to photophobia and Phonophobia, but both were significantly more sensitive to light and sound than controls (p 0.56). In cervicogenic headache patients, photophobia (p<0.05) but not Phonophobia (p=0.28) was greater on the symptomatic side than on the non-symptomatic side.
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photophobia and Phonophobia in tension type and cervicogenic headache
Cephalalgia, 1998Co-Authors: Vanagaite J Vingen, Lars Jacob StovnerAbstract:Light and sound-induced discomfort and pain thresholds were measured in 26 patients with cervicogenic headache, in 40 patients with tension-type headache, and in 100 headache-free controls. Neither headache group was significantly different as to photophobia and Phonophobia, but both were significantly more sensitive to light and sound than controls (p or =0.7). Tension-type headache patients were more photo- and phonophobic during headache than outside attack (p or =0.56). In cervicogenic headache patients, photophobia (p<0.05) but not Phonophobia (p=0.28) was greater on the symptomatic side than on the non-symptomatic side.
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Phonophobia in migraine
Cephalalgia, 1998Co-Authors: Vanagaite J Vingen, Ja Pareja, O Storen, Linda R White, Lars Jacob StovnerAbstract:Quantitative measurement of sound-induced discomfort and pain thresholds showed mat migraineurs (n = 65) were significantly more sensitive than headache-free controls (n = 80), both during and outside attack (p <0.0001). Patients tested with head pain had lower thresholds than those tested without pain (p <0.01). Migraine with and without aura did not differ as to sound sensitivity. There were no significant differences in thresholds between the symptomatic and nonsymptomatic sides (p ≥ 0.78). Patients with unilateral headache or pain of pulsating character were more sensitive than those with bilateral headache or pressing pain (p <0.05). Phonophobia did not correlate significantly with duration, frequency, or severity of attacks. The main results were in accordance with a questionnaire study concerning subjective evaluation of sound sensitivity. Similarities between Phonophobia and photophobia in migraine provide evidence mat both phenomena share a common pathophysiological mechanism in this condition.
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Quantitative evaluation of photophobia and Phonophobia in cluster headache.
Cephalalgia : an international journal of headache, 1998Co-Authors: J Vanagaite Vingen, Ja Pareja, Lars Jacob StovnerAbstract:In order to evaluate photophobia and Phonophobia in cluster headache (CH), light and sound-induced discomfort and pain thresholds were measured quantitatively in 50 patients and 50 sex-matched and age-matched headache-free controls. During bout (i.e., during the active period with attacks), CH patients were more sensitive to light and sound than controls (p< 0.001). Outside bout they did not differ significantly from controls except for binaural stimulation. Patients were more photophobic and phonophobic during bout than in the remission period (p≤0.05). However, for those tested during bout, the sensitivity to light and sound was not related to the presence of pain during test, usual pain intensity, or pain laterality. In response to a questionnaire about their sensitivity, a significantly higher proportion of patients considered themselves sensitive during bout than outside (91% vs 46% for light [X2=5.9, p< 0.05] and 89% vs 49% for sound [X2=4.7, p< 0.05]). These results indicate that photophobia and ph...
Stewart J Tepper - One of the best experts on this subject based on the ideXlab platform.
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use of most bothersome symptom as a coprimary endpoint in migraine clinical trials a post hoc analysis of the pivotal zotrip randomized controlled trial
Headache, 2018Co-Authors: David W Dodick, Stewart J Tepper, Deborah I Friedman, Amy A Gelfand, Donald J Kellerman, Peter C SchmidtAbstract:OBJECTIVE: To better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions. BACKGROUND: Adhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints per recently issued guidance by the US Food and Drug Administration. In this trial, the proportion of patients treated with ADAM zolmitriptan 3.8 mg, who were pain-free and MBS-free at 2 hours post-dose, was significantly higher than for placebo. METHODS: We undertook a post-hoc analysis of data from the ZOTRIP trial to examine how the outcomes from this trial compare to what might have been achieved using the conventional co-primary endpoints of pain relief, nausea, photophobia, and Phonophobia. RESULTS: Of the 159 patients treated with ADAM zolmitriptan 3.8 mg or placebo, prospectively designated MBS were photophobia (n = 79), Phonophobia (n = 43), and nausea (n = 37). Two-hour pain free rates in those with photophobia as the MBS were 36% for ADAM zolmitriptan 3.8 mg and 14% for placebo (P = .02). Corresponding rates for those with Phonophobia as the MBS were 14% and 41% (P = .05). For those whose MBS was nausea, corresponding values were 56% and 16%, respectively (P = .01). Two-hour freedom from the MBS for active drug vs placebo were 67% vs 35% (P < .01) for photophobia, 55% vs 43% (P = .45) for Phonophobia, and 89% vs 58% for nausea (P = .04). MBS freedom but not pain freedom was achieved in 28%. Only 1 patient (1%) achieved pain freedom, but not MBS freedom. The proportion with both pain and MBS freedom was highest (56%) among those whose MBS was nausea. CONCLUSION: In this study, the use of MBS was feasible and seemed to compare favorably to the previously required 4 co-primary endpoints.
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Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post-Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial.
Headache, 2018Co-Authors: David W Dodick, Stewart J Tepper, Deborah I Friedman, Amy A Gelfand, Donald J Kellerman, Peter C SchmidtAbstract:Author(s): Dodick, David W; Tepper, Stewart J; Friedman, Deborah I; Gelfand, Amy A; Kellerman, Donald J; Schmidt, Peter C | Abstract: OBJECTIVE:To better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions. BACKGROUND:Adhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints per recently issued guidance by the US Food and Drug Administration. In this trial, the proportion of patients treated with ADAM zolmitriptan 3.8 mg, who were pain-free and MBS-free at 2 hours post-dose, was significantly higher than for placebo. METHODS:We undertook a post-hoc analysis of data from the ZOTRIP trial to examine how the outcomes from this trial compare to what might have been achieved using the conventional co-primary endpoints of pain relief, nausea, photophobia, and Phonophobia. RESULTS:Of the 159 patients treated with ADAM zolmitriptan 3.8 mg or placebo, prospectively designated MBS were photophobia (n = 79), Phonophobia (n = 43), and nausea (n = 37). Two-hour pain free rates in those with photophobia as the MBS were 36% for ADAM zolmitriptan 3.8 mg and 14% for placebo (P = .02). Corresponding rates for those with Phonophobia as the MBS were 14% and 41% (P = .05). For those whose MBS was nausea, corresponding values were 56% and 16%, respectively (P = .01). Two-hour freedom from the MBS for active drug vs placebo were 67% vs 35% (P l .01) for photophobia, 55% vs 43% (P = .45) for Phonophobia, and 89% vs 58% for nausea (P = .04). MBS freedom but not pain freedom was achieved in 28%. Only 1 patient (1%) achieved pain freedom, but not MBS freedom. The proportion with both pain and MBS freedom was highest (56%) among those whose MBS was nausea. CONCLUSION:In this study, the use of MBS was feasible and seemed to compare favorably to the previously required 4 co-primary endpoints.
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map0004 orally inhaled dhe a randomized controlled study in the acute treatment of migraine
Headache, 2011Co-Authors: Sheena K Aurora, Stewart J Tepper, Stephen D Silberstein, Shashidhar Kori, Scott Borland, Min Wang, David W DodickAbstract:(Headache 2011;51:507-517) Objective.— To evaluate the efficacy and tolerability of MAP0004 compared with placebo for a single migraine in adult migraineurs: The FREEDOM-301 Study. Background.— Acute treatment of migraine remains a clinical challenge despite the availability of triptans and other agents. Injectable dihydroergotamine, although effective, is considered invasive and inconvenient, and intranasal dihydroergotamine is associated with inconsistent systemic dosage delivery. MAP0004 is an orally inhaled formulation of dihydroergotamine delivered to the systemic circulation. In a phase 2 study, MAP0004 provided significant early onset of pain relief (10 minutes, P < .05) and sustained pain relief for up to 48 hours with a favorable adverse event profile. Methods.— A phase 3, randomized, double-blind, placebo-controlled, parallel-group, single-attack, outpatient study of MAP0004, an inhaled dihydroergotamine was conducted at 102 sites in 903 adults with a history of episodic migraine. Patients were randomized (1:1) to receive MAP0004 (0.63 mg emitted dose; 1.0 mg nominal dose) or placebo, administered after onset of a migraine headache with moderate to severe pain. The co-primary endpoints were patient-assessed pain relief and absence of photophobia, Phonophobia, and nausea at 2 hours after treatment. Results.— A total of 903 patients (450 active, 453 placebo) were randomized, and 792 (395 active, 397 placebo) experienced a qualifying migraine. MAP0004 was superior to placebo in all 4 co-primary endpoints: pain relief (58.7% vs 34.5%, P < .0001), Phonophobia free (52.9% vs 33.8%, P < .0001), photophobia free (46.6% vs 27.2%, P < .0001), and nausea free (67.1% vs 58.7%, P = .0210). Additionally, significantly more patients were pain-free at 2 hours following treatment with MAP0004 than with placebo (28.4% vs 10.1%, P < .0001). MAP0004 was well tolerated; no drug-related serious adverse events occurred. Conclusions.— In this study, MAP0004 was effective and well tolerated for the acute treatment of migraine with or without aura, providing statistically significant pain relief and freedom from photophobia, Phonophobia, and nausea in adults with migraine compared with placebo.
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Intravenous magnesium sulphate in the acute treatment of migraine without aura and migraine with aura. A randomized, double-blind, placebo-controlled study.
Cephalalgia : an international journal of headache, 2002Co-Authors: Marcelo E. Bigal, Stewart J Tepper, Carlos A. Bordini, José Geraldo SpecialiAbstract:Magnesium sulphate has been used in the acute treatment of migraines; some studies found it to be a highly effective medication in the acute control of migraine pain and associated symptoms. This randomized, double-blind, placebo-controlled study assesses the effect of magnesium sulphate on the pain and associated symptoms in patients with migraine without aura and migraine with aura. Sixty patients in each group were assigned at random to receive magnesium sulphate, 1000 mg intravenously, or 0.9% physiological saline, 10 ml. We used seven parameters of analgesic evaluation and an analogue scale to assess nausea, photophobia and Phonophobia. In the migraine without aura group there was no statistically significant difference in the patients who received magnesium sulphate vs. placebo in pain relief. The analgesic therapeutic gain was 17% and number needed to treat was 5.98 at 1 h. There was also no statistical difference in relief of nausea. We did observe a significant lower intensity of photophobia and Phonophobia in patients who received magnesium sulphate. In the migraine with aura group patients receiving magnesium sulphate presented a statistically significant improvement of pain and of all associated symptoms compared with controls. The analgesic therapeutic gain was 36.7% at 1 h. A smaller number of patients continued to have aura in the magnesium sulphate group compared with placebo 1 h after the administration of medication. Our data support the idea that magnesium sulphate can be used for the treatment of all symptoms in migraine with aura, or as an adjuvant therapy for associated symptoms in patients with migraine without aura.
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Intravenous Dipyrone in the Acute Treatment of Migraine Without Aura and Migraine with Aura: A Randomized, Double Blind, Placebo Controlled Study
Headache, 2002Co-Authors: Marcelo E. Bigal, Stewart J Tepper, Carlos A. Bordini, José Geraldo SpecialiAbstract:Background.— Dipyrone (Metamizol) has been used in the acute treatment of migraines in Brazil. Some investigators have found it to be a highly effective medication for migraine pain and associated symptoms. Objective.—To conduct a randomized, placebo controlled, double blind study to assess the effect of dipyrone on the pain and symptoms associated with migraine without aura or with aura and the adverse effect profile of this medication. Methods.—For the migraine without aura group, 44 patients were assigned at random to receive 1 g intravenous dipyrone, and 30 patients received 10 mL 0.9% physiological saline. For the migraine with aura group, 30 patients received both dipyrone or placebo. We used seven parameters of analgesic evaluation and an analog scale to assess nausea, photophobia, and Phonophobia. Results.—Patients receiving dipyrone demonstrated a statistically superior improvement (P
David W Dodick - One of the best experts on this subject based on the ideXlab platform.
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Most Bothersome Symptom in Persons With Migraine: Results From the Migraine in America Symptoms and Treatment (MAST) Study.
Headache, 2019Co-Authors: Sagar Munjal, Todd J. Schwedt, David W Dodick, Preeti Singh, Michael L. Reed, Kristina M. Fanning, Dawn C. Buse, Richard B LiptonAbstract:OBJECTIVES The objectives of this study were to determine the rates of nausea, Phonophobia, and photophobia reported overall and as the most bothersome symptom (MBS) in individuals with migraine and to identify individual characteristics associated with each of the 3 candidate MBSs. BACKGROUND The MBS has emerged as an important coprimary efficacy endpoint in clinical trials of acute treatments for migraine, as recommended by the Food and Drug Administration. The current understanding of how persons with migraine designate an associated symptom as the most bothersome has been assessed primarily in the context of randomized trials. METHODS Respondents (n = 95,821) in the cross-sectional, observational Migraine in America Symptoms and Treatment (MAST) study were adults (aged ≥18 years) recruited from a US nationwide online research panel. A validated diagnostic screener identified 15,133 individuals who met modified International Classification of Headache Disorders (ICHD)-3 beta criteria for migraine and reported at least 1 monthly headache day (MHD) over the previous 3 months. The survey ascertained sociodemographic variables, headache-related disability, MHDs, cutaneous allodynia, medication overuse, a migraine symptom severity score, pain interference, noncephalic pain, anxiety and depression symptoms, visual aura over the previous year, and acute treatment optimization. The current analysis is based on respondents who also completed a 6-month follow-up assessment that included questions about their most bothersome headache symptom. RESULTS A total of 7518 respondents completed the 6-month follow-up, and 6045 met inclusion criteria and were included in the analysis. The mean age of respondents was 47 (SD 13.4) years, 76.0% (4596/6045) were women, and 84.8% (5103/6017) were white. Among all respondents, 64.9% reported all 3 migraine symptoms. The MBS was photophobia in 49.1% (2967/6045), nausea in 28.1% (1697/6045), and Phonophobia in 22.8% (1381/6045). Respondents reporting photophobia as the MBS were more likely to be men, to be obese, and to report visual aura. Those reporting nausea as the MBS were more likely to be women, to have lower incomes, and to report lower levels of treatment optimization. Respondents reporting Phonophobia as the MBS were more likely to have cutaneous allodynia and less likely to have visual aura. CONCLUSION Most people with migraine in the MAST observational study reported all 3 cardinal symptoms of nausea, photophobia, and Phonophobia. As in clinical trials, the most common MBS was photophobia. Patient profiles differed among the groups defined by their MBS.
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use of most bothersome symptom as a coprimary endpoint in migraine clinical trials a post hoc analysis of the pivotal zotrip randomized controlled trial
Headache, 2018Co-Authors: David W Dodick, Stewart J Tepper, Deborah I Friedman, Amy A Gelfand, Donald J Kellerman, Peter C SchmidtAbstract:OBJECTIVE: To better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions. BACKGROUND: Adhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints per recently issued guidance by the US Food and Drug Administration. In this trial, the proportion of patients treated with ADAM zolmitriptan 3.8 mg, who were pain-free and MBS-free at 2 hours post-dose, was significantly higher than for placebo. METHODS: We undertook a post-hoc analysis of data from the ZOTRIP trial to examine how the outcomes from this trial compare to what might have been achieved using the conventional co-primary endpoints of pain relief, nausea, photophobia, and Phonophobia. RESULTS: Of the 159 patients treated with ADAM zolmitriptan 3.8 mg or placebo, prospectively designated MBS were photophobia (n = 79), Phonophobia (n = 43), and nausea (n = 37). Two-hour pain free rates in those with photophobia as the MBS were 36% for ADAM zolmitriptan 3.8 mg and 14% for placebo (P = .02). Corresponding rates for those with Phonophobia as the MBS were 14% and 41% (P = .05). For those whose MBS was nausea, corresponding values were 56% and 16%, respectively (P = .01). Two-hour freedom from the MBS for active drug vs placebo were 67% vs 35% (P < .01) for photophobia, 55% vs 43% (P = .45) for Phonophobia, and 89% vs 58% for nausea (P = .04). MBS freedom but not pain freedom was achieved in 28%. Only 1 patient (1%) achieved pain freedom, but not MBS freedom. The proportion with both pain and MBS freedom was highest (56%) among those whose MBS was nausea. CONCLUSION: In this study, the use of MBS was feasible and seemed to compare favorably to the previously required 4 co-primary endpoints.
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Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post-Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial.
Headache, 2018Co-Authors: David W Dodick, Stewart J Tepper, Deborah I Friedman, Amy A Gelfand, Donald J Kellerman, Peter C SchmidtAbstract:Author(s): Dodick, David W; Tepper, Stewart J; Friedman, Deborah I; Gelfand, Amy A; Kellerman, Donald J; Schmidt, Peter C | Abstract: OBJECTIVE:To better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions. BACKGROUND:Adhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints per recently issued guidance by the US Food and Drug Administration. In this trial, the proportion of patients treated with ADAM zolmitriptan 3.8 mg, who were pain-free and MBS-free at 2 hours post-dose, was significantly higher than for placebo. METHODS:We undertook a post-hoc analysis of data from the ZOTRIP trial to examine how the outcomes from this trial compare to what might have been achieved using the conventional co-primary endpoints of pain relief, nausea, photophobia, and Phonophobia. RESULTS:Of the 159 patients treated with ADAM zolmitriptan 3.8 mg or placebo, prospectively designated MBS were photophobia (n = 79), Phonophobia (n = 43), and nausea (n = 37). Two-hour pain free rates in those with photophobia as the MBS were 36% for ADAM zolmitriptan 3.8 mg and 14% for placebo (P = .02). Corresponding rates for those with Phonophobia as the MBS were 14% and 41% (P = .05). For those whose MBS was nausea, corresponding values were 56% and 16%, respectively (P = .01). Two-hour freedom from the MBS for active drug vs placebo were 67% vs 35% (P l .01) for photophobia, 55% vs 43% (P = .45) for Phonophobia, and 89% vs 58% for nausea (P = .04). MBS freedom but not pain freedom was achieved in 28%. Only 1 patient (1%) achieved pain freedom, but not MBS freedom. The proportion with both pain and MBS freedom was highest (56%) among those whose MBS was nausea. CONCLUSION:In this study, the use of MBS was feasible and seemed to compare favorably to the previously required 4 co-primary endpoints.
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map0004 orally inhaled dhe a randomized controlled study in the acute treatment of migraine
Headache, 2011Co-Authors: Sheena K Aurora, Stewart J Tepper, Stephen D Silberstein, Shashidhar Kori, Scott Borland, Min Wang, David W DodickAbstract:(Headache 2011;51:507-517) Objective.— To evaluate the efficacy and tolerability of MAP0004 compared with placebo for a single migraine in adult migraineurs: The FREEDOM-301 Study. Background.— Acute treatment of migraine remains a clinical challenge despite the availability of triptans and other agents. Injectable dihydroergotamine, although effective, is considered invasive and inconvenient, and intranasal dihydroergotamine is associated with inconsistent systemic dosage delivery. MAP0004 is an orally inhaled formulation of dihydroergotamine delivered to the systemic circulation. In a phase 2 study, MAP0004 provided significant early onset of pain relief (10 minutes, P < .05) and sustained pain relief for up to 48 hours with a favorable adverse event profile. Methods.— A phase 3, randomized, double-blind, placebo-controlled, parallel-group, single-attack, outpatient study of MAP0004, an inhaled dihydroergotamine was conducted at 102 sites in 903 adults with a history of episodic migraine. Patients were randomized (1:1) to receive MAP0004 (0.63 mg emitted dose; 1.0 mg nominal dose) or placebo, administered after onset of a migraine headache with moderate to severe pain. The co-primary endpoints were patient-assessed pain relief and absence of photophobia, Phonophobia, and nausea at 2 hours after treatment. Results.— A total of 903 patients (450 active, 453 placebo) were randomized, and 792 (395 active, 397 placebo) experienced a qualifying migraine. MAP0004 was superior to placebo in all 4 co-primary endpoints: pain relief (58.7% vs 34.5%, P < .0001), Phonophobia free (52.9% vs 33.8%, P < .0001), photophobia free (46.6% vs 27.2%, P < .0001), and nausea free (67.1% vs 58.7%, P = .0210). Additionally, significantly more patients were pain-free at 2 hours following treatment with MAP0004 than with placebo (28.4% vs 10.1%, P < .0001). MAP0004 was well tolerated; no drug-related serious adverse events occurred. Conclusions.— In this study, MAP0004 was effective and well tolerated for the acute treatment of migraine with or without aura, providing statistically significant pain relief and freedom from photophobia, Phonophobia, and nausea in adults with migraine compared with placebo.
José Geraldo Speciali - One of the best experts on this subject based on the ideXlab platform.
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Migraine with aura versus migraine without aura: pain intensity and associated symptom intensities after placebo.
Headache, 2002Co-Authors: Marcelo E. Bigal, Carlos A. Bordini, Fred D. Sheftell, José Geraldo Speciali, Janaína O. M. BigalAbstract:Objective.—To compare the intensity of pain and associated symptoms after placebo administration in patients with migraine with aura and migraine without aura. Background.—Studies that evaluate drugs used in the acute treatment of migraine ideally should include a placebo arm. The International Headache Society also recommends stratification according to age and sex but not by the presence versus absence of aura. Methods.—The study was conducted as part of a placebo controlled randomized survey comparing four active drugs against placebo in the acute treatment of migraine. Patients were blinded as to treatment received. Placebo consisted of 10 mL of normal saline (0.9%) intravenously. Pain intensity was evaluated by a 10-point analogical-verbal scale. Nausea, photophobia, and Phonophobia were evaluated by a four-point analogical-verbal scale. For statistical analysis, unpaired t-test with Welch correction was used. Results.—After placebo administration, reduction of symptom intensity (pain, nausea, photophobia, and Phonophobia) in patients with migraine without aura was significantly greater than that observed in patients with migraine with aura. Conclusions.—Our findings suggest that studies comparing placebo against an active drug should use stratification according to the presence versus absence of aura.
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Intravenous chlorpromazine in the emergency department treatment of migraines: a randomized controlled trial.
The Journal of emergency medicine, 2002Co-Authors: Marcelo E. Bigal, Carlos A. Bordini, José Geraldo SpecialiAbstract:The aim of this study is to assess, in a double blind randomized clinical trial, the effect of Chlorpromazine (CPZ) on the pain and associated symptoms in patients with migraine. Sixty patients with migraine with aura and 68 patients with migraine without aura were assigned at random to receive IV 0.1 mg/Kg CPZ or placebo. We assessed pain intensity, nausea, photophobia, and Phonophobia at baseline, 30 min, and 60 min post-IV administration. End-point efficacy at 60 min was used to calculate the number needed to treat (NNT). We also recorded adverse effects, need for rescue medication at 24 h, and recurrence of headache at 24 h. We found clinically and statistically significant (p < 0.01) improvement associated with CPZ in pain scores, nausea, photophobia, Phonophobia, and need for rescue medication, all at 60 min, and in rate of recurrence at 24 h, both in patients with and without aura. NNT = 2. Those allocated to CPZ had less nausea and dyspepsia, but more drowsiness and postural hypotension than those receiving placebo. CPZ is an excellent option for the treatment of migraines, with and without aura, in the Emergency Department.
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Intravenous magnesium sulphate in the acute treatment of migraine without aura and migraine with aura. A randomized, double-blind, placebo-controlled study.
Cephalalgia : an international journal of headache, 2002Co-Authors: Marcelo E. Bigal, Stewart J Tepper, Carlos A. Bordini, José Geraldo SpecialiAbstract:Magnesium sulphate has been used in the acute treatment of migraines; some studies found it to be a highly effective medication in the acute control of migraine pain and associated symptoms. This randomized, double-blind, placebo-controlled study assesses the effect of magnesium sulphate on the pain and associated symptoms in patients with migraine without aura and migraine with aura. Sixty patients in each group were assigned at random to receive magnesium sulphate, 1000 mg intravenously, or 0.9% physiological saline, 10 ml. We used seven parameters of analgesic evaluation and an analogue scale to assess nausea, photophobia and Phonophobia. In the migraine without aura group there was no statistically significant difference in the patients who received magnesium sulphate vs. placebo in pain relief. The analgesic therapeutic gain was 17% and number needed to treat was 5.98 at 1 h. There was also no statistical difference in relief of nausea. We did observe a significant lower intensity of photophobia and Phonophobia in patients who received magnesium sulphate. In the migraine with aura group patients receiving magnesium sulphate presented a statistically significant improvement of pain and of all associated symptoms compared with controls. The analgesic therapeutic gain was 36.7% at 1 h. A smaller number of patients continued to have aura in the magnesium sulphate group compared with placebo 1 h after the administration of medication. Our data support the idea that magnesium sulphate can be used for the treatment of all symptoms in migraine with aura, or as an adjuvant therapy for associated symptoms in patients with migraine without aura.
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Intravenous Dipyrone in the Acute Treatment of Migraine Without Aura and Migraine with Aura: A Randomized, Double Blind, Placebo Controlled Study
Headache, 2002Co-Authors: Marcelo E. Bigal, Stewart J Tepper, Carlos A. Bordini, José Geraldo SpecialiAbstract:Background.— Dipyrone (Metamizol) has been used in the acute treatment of migraines in Brazil. Some investigators have found it to be a highly effective medication for migraine pain and associated symptoms. Objective.—To conduct a randomized, placebo controlled, double blind study to assess the effect of dipyrone on the pain and symptoms associated with migraine without aura or with aura and the adverse effect profile of this medication. Methods.—For the migraine without aura group, 44 patients were assigned at random to receive 1 g intravenous dipyrone, and 30 patients received 10 mL 0.9% physiological saline. For the migraine with aura group, 30 patients received both dipyrone or placebo. We used seven parameters of analgesic evaluation and an analog scale to assess nausea, photophobia, and Phonophobia. Results.—Patients receiving dipyrone demonstrated a statistically superior improvement (P
Richard B Lipton - One of the best experts on this subject based on the ideXlab platform.
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Most Bothersome Symptom in Persons With Migraine: Results From the Migraine in America Symptoms and Treatment (MAST) Study.
Headache, 2019Co-Authors: Sagar Munjal, Todd J. Schwedt, David W Dodick, Preeti Singh, Michael L. Reed, Kristina M. Fanning, Dawn C. Buse, Richard B LiptonAbstract:OBJECTIVES The objectives of this study were to determine the rates of nausea, Phonophobia, and photophobia reported overall and as the most bothersome symptom (MBS) in individuals with migraine and to identify individual characteristics associated with each of the 3 candidate MBSs. BACKGROUND The MBS has emerged as an important coprimary efficacy endpoint in clinical trials of acute treatments for migraine, as recommended by the Food and Drug Administration. The current understanding of how persons with migraine designate an associated symptom as the most bothersome has been assessed primarily in the context of randomized trials. METHODS Respondents (n = 95,821) in the cross-sectional, observational Migraine in America Symptoms and Treatment (MAST) study were adults (aged ≥18 years) recruited from a US nationwide online research panel. A validated diagnostic screener identified 15,133 individuals who met modified International Classification of Headache Disorders (ICHD)-3 beta criteria for migraine and reported at least 1 monthly headache day (MHD) over the previous 3 months. The survey ascertained sociodemographic variables, headache-related disability, MHDs, cutaneous allodynia, medication overuse, a migraine symptom severity score, pain interference, noncephalic pain, anxiety and depression symptoms, visual aura over the previous year, and acute treatment optimization. The current analysis is based on respondents who also completed a 6-month follow-up assessment that included questions about their most bothersome headache symptom. RESULTS A total of 7518 respondents completed the 6-month follow-up, and 6045 met inclusion criteria and were included in the analysis. The mean age of respondents was 47 (SD 13.4) years, 76.0% (4596/6045) were women, and 84.8% (5103/6017) were white. Among all respondents, 64.9% reported all 3 migraine symptoms. The MBS was photophobia in 49.1% (2967/6045), nausea in 28.1% (1697/6045), and Phonophobia in 22.8% (1381/6045). Respondents reporting photophobia as the MBS were more likely to be men, to be obese, and to report visual aura. Those reporting nausea as the MBS were more likely to be women, to have lower incomes, and to report lower levels of treatment optimization. Respondents reporting Phonophobia as the MBS were more likely to have cutaneous allodynia and less likely to have visual aura. CONCLUSION Most people with migraine in the MAST observational study reported all 3 cardinal symptoms of nausea, photophobia, and Phonophobia. As in clinical trials, the most common MBS was photophobia. Patient profiles differed among the groups defined by their MBS.
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dfn 02 sumatriptan 10 mg with a permeation enhancer nasal spray vs placebo in the acute treatment of migraine a double blind placebo controlled study
Headache, 2018Co-Authors: Richard B Lipton, Sagar Munjal, Elimor Brandschieber, A M RapoportAbstract:OBJECTIVE: The objective of this study was to evaluate the efficacy, safety, and tolerability of DFN-02 - a nasal spray comprising sumatriptan 10 mg and a permeation-enhancing excipient (0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside [DDM]) - for the acute treatment of migraine with or without aura in adults. BACKGROUND: Prior work has shown that DFN-02, which contains only half the recommended adult dose of sumatriptan found in the original formulation (10 mg vs 20 mg), is more rapidly absorbed than commercial nasal spray of sumatriptan, with favorable pharmacokinetic and safety profiles. The efficacy of DFN-02 in the acute treatment of migraine has not been previously assessed. METHODS: This was a multicenter, randomized, 2-period, double-blind, placebo-controlled efficacy, safety, and tolerability phase 2 study of DFN-02. Subjects with at least a 12 month history of episodic migraine, who averaged 2-8 attacks per month, with no more than 14 headache days per month and a minimum of 48 headache-free hours between attacks, were randomized (1:1) to receive DFN-02 or a matching placebo. Subjects were instructed to treat a single migraine attack of moderate to severe pain intensity. The primary efficacy endpoint, the proportion of subjects who were pain-free at 2 hours postdose in the first double-blind treatment period, was assessed with 2 protocol prespecified primary analyses: last observation carried forward (LOCF) and observed cases (OC). Secondary efficacy endpoints at 2 hours included pain relief; absence of the most bothersome symptom (MBS) among nausea, photophobia, and Phonophobia; freedom from nausea, photophobia, and Phonophobia. Sustained pain freedom from 2 through 24 hours postdose was also assessed. RESULTS: Of 107 subjects randomized, 86.9% (N = 93 [DFN-02, n = 50; placebo, n = 43]) had data in the first double-blind treatment period. The study met its primary endpoint; the proportion of subjects who were free from headache pain at 2 hours postdose, was statistically significantly higher in the DFN-02 group than in the placebo group in both prespecified primary analyses: LOCF (DFN-02, n = 21/48; placebo, n = 9/40; 43.8% vs 22.5%, P = .044) and OC (DFN-02, n = 21/48; placebo, n = 8/39; 43.8% vs 20.5%, P = .025). For secondary efficacy endpoints, at 2 hours postdose, DFN-02 was also statistically significantly superior to placebo for the proportion of subjects who had pain relief (83.3% vs 55.0%, P = .005); who were free of their MBS (70.7% vs 39.5%, P = .007); and who were free of nausea (78.3% vs 42.1%, P = .026), photophobia (71.8% vs 38.9%, P = .005), and Phonophobia (78.1% vs 40.0%, P = .004). Compared with placebo, statistically significantly greater proportions of subjects who were treated with DFN-02 had sustained pain freedom from 2 through 24 hours postdose (38.9% vs 13.8%, P = .029). In total, 9.7% (9/93) of subjects reported a treatment-emergent adverse event during the study: 10.0% (5/50) of DFN-02 subjects in the first double-blind treatment period and 13.5% (5/37) of DFN-02 subjects in the second double-blind treatment period. The most common treatment-emergent adverse event with DFN-02 was dysgeusia (3/37 subjects in the second double-blind treatment period). CONCLUSIONS: DFN-02 was shown to be effective, well tolerated, and safe in the acute treatment of episodic migraine. Additional studies are needed to confirm these preliminary results. (ClinicalTrials.gov Identifier: NCT02856802).
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Clinical and prognostic subforms of new daily-persistent headache.
Neurology, 2010Co-Authors: Matthew S Robbins, Brian M. Grosberg, U. Napchan, S.c. Crystal, Richard B LiptonAbstract:I thank Robbins et al.1 for their observations on new daily-persistent headache (NDPH). Migrainous features including nausea, vomiting, photophobia, and Phonophobia are not acknowledged in the International Headache Society criteria for NDPH. However, Robbins et al. note that these features are common. We recently reported 9 patients with postinfectious NDPH. Five had nausea and of these patients, 4 had photophobia, Phonophobia, or both.2 Tension-type headache and migraine are separate disease entities with different pathogeneses. Treatment options also differ. Dividing NDPH into tension-type and migraine subtypes suggests that NDPH may be merely descriptive and may include different headache disorders such as tension-type NDPH, migrainous-type NDPH, or secondary NDPH. The prognosis of NDPH varies, ranging from self-limiting to refractory, which suggests that NDPH is a heterogeneous disorder. To make a …
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single pulse transcranial magnetic stimulation for acute treatment of migraine with aura a randomised double blind parallel group sham controlled trial
Lancet Neurology, 2010Co-Authors: Richard B Lipton, Sheena K Aurora, Stephen D Silberstein, David William Dodick, Joel R Saper, Starr H Pearlman, Robert E Fischell, Patricia L Ruppel, Peter J. GoadsbyAbstract:Summary Background Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura. Methods We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA. 267 adults aged 18–68 years were enrolled into phase one. All individuals had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. 66 patients dropped out during phase one. In phase two, 201 individuals were randomly allocated by computer to either sham stimulation (n=99) or sTMS (n=102). We instructed participants to treat up to three attacks over 3 months while experiencing aura. The primary outcome was pain-free response 2 h after the first attack, and co-primary outcomes were non-inferiority at 2 h for nausea, photophobia, and Phonophobia. Analyses were modified intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT00449540. Findings 37 patients did not treat a migraine attack and were excluded from outcome analyses. 164 patients treated at least one attack with sTMS (n=82) or sham stimulation (n=82; modified intention-to-treat analysis set). Pain-free response rates after 2 h were significantly higher with sTMS (32/82 [39%]) than with sham stimulation (18/82 [22%]), for a therapeutic gain of 17% (95% CI 3–31%; p=0·0179). Sustained pain-free response rates significantly favoured sTMS at 24 h and 48 h post-treatment. Non-inferiority was shown for nausea, photophobia, and Phonophobia. No device-related serious adverse events were recorded, and incidence and severity of adverse events were similar between sTMS and sham groups. Interpretation Early treatment of migraine with aura by sTMS resulted in increased freedom from pain at 2 h compared with sham stimulation, and absence of pain was sustained 24 h and 48 h after treatment. sTMS could be a promising acute treatment for some patients with migraine with aura. Funding Neuralieve.
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Migraine's impact today. Burden of illness, patterns of care.
Postgraduate medicine, 2001Co-Authors: Richard B Lipton, Michael L. Reed, Walter F. Stewart, Seymour DiamondAbstract:PREVIEWMigraine is a common disorder that causes severe headaches and associated nausea, photophobia, Phonophobia, and temporary disability. Though the pain and other symptoms of migraine can be effectively man' aged, the condition remains underdiagnosed and undertreated. In this article, Drs Lipton, Stewart, Reed, and Diamond consider the scope and distribution of the migraine problem and the current patterns of care in the United States.