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Peter J. Goadsby - One of the best experts on this subject based on the ideXlab platform.
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single pulse transcranial magnetic stimulation stms for the acute treatment of migraine evaluation of outcome data for the uk post market pilot program
Journal of Headache and Pain, 2015Co-Authors: Ria Bhola, Peter J. Goadsby, Evelyn Kinsella, Nicola Giffin, Sue Lipscombe, Fayyaz Ahmed, Mark W WeatherallAbstract:Single pulse transcranial magnetic stimulation (sTMS) is a novel treatment for acute migraine. Previous randomised controlled data demonstrated that sTMS is effective and well tolerated in the treatment of migraine with aura. The aim of the programme reported here was to evaluate patient responses in the setting of routine clinical practice. Migraine patients with and without aura treating with sTMS had an initial review (n = 426) and training call, and then participated in telephone surveys at week six (n = 331) and week 12 during a 3-month treatment period (n = 190). Of patients surveyed with 3 month data (n = 190; episodic, n = 59; chronic, n = 131), 62 % reported pain relief, finding the device effective at reducing or alleviating migraine pain; in addition there was relief reported of associated features: nausea- 52 %; Photophobia- 55 %; and phonophobia- 53 %. At 3 months there was a reduction in monthly headache days for episodic migraine, from 12 (median, 8–13 IQ range) to 9 (4–12) and for chronic migraine, a reduction from 24 (median, 16–30 IQ range) to 16 (10–30). There were no serious or unanticipated adverse events. sTMS may be a valuable addition to options for the treatment of both episodic and chronic migraine.
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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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14th International Headache Congress: Basic Science Highlights
Headache, 2010Co-Authors: Todd J. Schwedt, Peter J. GoadsbyAbstract:: During the 14th International Headache Congress the results of several innovative studies that contribute to our understanding of headache pathophysiology and treatment were presented. Here we summarize work expected to contribute substantially to understanding headache mechanisms, while an accompanying manuscript summarizes presentations regarding the treatment of headache. This manuscript highlights research on mechanisms of Photophobia and phonophobia, pharmacologic inhibition of cortical spreading depression, a proposed mechanism by which oxygen effectively treats cluster headache, identification of functional and structural aberrations in people with hypnic headache, and research on functional imaging markers of a migraine attack.
A M Rapoport - One of the best experts on this subject based on the ideXlab platform.
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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, 2018Co-Authors: Stephen Landy, Elimor Brandschieber, Sagar Munjal, A M RapoportAbstract: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).
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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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DIAGNOSIS OF MIGRAINE
Seminars in Neurology, 2008Co-Authors: David R. Marks, A M RapoportAbstract:Migraine headache is a common and increasing problem in the United States; it is under-recognized and under-reported. The clarification of headaches by the International Headache Society (IHS) has become the standard for the diagnosis of migraine and other headache disorders. It categorizes most migraine headaches under the following diagnosis: migraine without aura, migraine with aura, ophthalmoplegic migraine, and retinal migraine. Diagnostic criteria used to make the diagnosis of migraine include such factors as the location and character of headache pain; the extent to which pain inhibits function; the effect of physical activity on the pain; and the presence of nausea, vomiting, Photophobia, or phonophobia. Proper use of the IHS classification and diagnostic criteria is important for accurate diagnosis and treatment of migraine, as well as for standardization of patients for research protocols.
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Frovatriptan: pharmacological differences and clinical results.
Current medical research and opinion, 2001Co-Authors: A M RapoportAbstract:Frovatriptan is a 5-HT(1B/1D) agonist demonstrating consistently effective headache relief at a low dose of 2.5 mg. A striking pharmacokinetic characteristic is its long half-life of 25 h. This is balanced by an average Tmax of 2-3 h, a low degree of lipophilicity and a low oral bioavailability of 24-30%. Fifty per cent of the drug is renally excreted and the rest is partially metabolized by P450 CYP 1A2. In three short-term multicentre, double-blind, placebo-controlled phase III trials, the 2 h headache response for 2.5 mg frovatriptan varied from 36 to 46% (placebo 21-27%). The 4 h headache responses were considerably higher--up to 65%. Thirty-five per cent of patients were consistent rapid responders. The recurrence rate was 10-25%. In addition to effective and prolonged relief of head pain, frovatriptan reduced associated migraine symptoms such as nausea, Photophobia and phonophobia. There was an excellent tolerability profile with the incidence of adverse events for frovatriptan only slightly higher than placebo. The most commonly reported adverse events for both frovatriptan and placebo were dizziness, nausea, headache and fatigue.
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Frovatriptan: pharmacological differences and clinical results.
Current Medical Research and Opinion, 2001Co-Authors: A M RapoportAbstract:SUMMARYFrovatriptan is a 5-HT1B/1D agonist demonstrating consistently effective headache relief at a low dose of 2.5 mg. A striking pharmacokinetic characteristic is its long half-life of 25 h. This is balanced by an average Tmax of 2–3 h, a low degree of lipophilicity and a low oral bioavailability of 24–30%. Fifty per cent of the drug is renally excreted and the rest is partially metabolized by P450 CYP 1A2. In three short-term multicentre, double-blind, placebo-controlled phase III trials, the 2 h headache response for 2.5 mg frovatriptan varied from 36 to 46% (placebo 21–27%). The 4 h headache responses were considerably higher – up to 65%. Thirty-five per cent of patients were consistent rapid responders. The recurrence rate was 10–25%. In addition to effective and prolonged relief of head pain, frovatriptan reduced associated migraine symptoms such as nausea, Photophobia and phonophobia. There was an excellent tolerability profile with the incidence of adverse events for frovatriptan only slightly h...
Richard B Lipton - One of the best experts on this subject based on the ideXlab platform.
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lasmiditan is an effective acute treatment for migraine a phase 3 randomized study
Neurology, 2018Co-Authors: Bernice Kuca, Stephen D Silberstein, Linda Wietecha, Paul H Berg, Gregory Dozier, Richard B LiptonAbstract:Objective To assess the efficacy and safety of lasmiditan in the acute treatment of migraine. Methods Adult patients with migraine were randomized (1:1:1) to a double-blind dose of oral lasmiditan 200 mg, lasmiditan 100 mg, or placebo and were asked to treat their next migraine attack within 4 hours of onset. Over 48 hours after dosing, patients used an electronic diary to record headache pain and the presence of nausea, phonophobia, and Photophobia, one of which was designated their most bothersome symptom (MBS). Results Of the 1,856 patients who treated an attack, 77.9% had ≥1 cardiovascular risk factors in addition to migraine. Compared with placebo, more patients dosed with lasmiditan 200 mg were free of headache pain at 2 hours after dosing (32.2% vs 15.3%; odds ratio [OR] 2.6, 95% confidence interval [CI] 2.0–3.6, p p p p Conclusions Lasmiditan dosed at 200 and 100 mg was efficacious and well tolerated in the treatment of acute migraine among patients with a high level of cardiovascular risk factors. ClinicalTrials.gov identifier NCT02439320. Classification of evidence This study provides Class I evidence that for adult patients with migraine, lasmiditan increases the proportion of subjects who are headache pain free at 2 hours after treating a migraine attack.
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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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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.
Andrew R Moore - One of the best experts on this subject based on the ideXlab platform.
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sumatriptan subcutaneous route of administration for acute migraine attacks in adults
Cochrane Database of Systematic Reviews, 2012Co-Authors: Christopher J Derry, Sheena Derry, Andrew R MooreAbstract:Background Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. Subcutaneous administration may be preferable to oral for individuals experiencing nausea and/or vomiting Objectives To determine the efficacy and tolerability of subcutaneous sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults. Search methods We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011. Selection criteria We included randomised, double-blind, placebo- and/or active-controlled studies using subcutaneous sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm. Data collection and analysis Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment. Main results Thirty-five studies (9365 participants) compared subcutaneous sumatriptan with placebo or an active comparator. Most of the data were for the 6 mg dose. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 6 mg versus placebo the NNTs were 2.9, 2.3, 2.2, and 2.1 for pain-free at one and two hours, and headache relief at one and two hours, respectively, and 6.1 for sustained pain-free at 24 hours. Results for the 4 mg and 8 mg doses were similar to the 6 mg dose, with 6 mg significantly better than 4 mg only for pain-free at one hour, and 8 mg significantly better than 6 mg only for headache relief at one hour. There was no evidence of increased migraine relief if a second dose of sumatriptan 6 mg was given after an inadequate response to the first. Relief of headache-associated symptoms, including nausea, Photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than placebo. For the most part, adverse events were transient and mild and were more common with sumatriptan than placebo. Sumatriptan was compared directly with a number of active treatments, including other triptans, acetylsalicylic acid plus metoclopramide, and dihydroergotamine, but there were insufficient data for any pooled analyses. Authors' conclusions Subcutaneous sumatriptan is effective as an abortive treatment for acute migraine attacks, quickly relieving pain, nausea, Photophobia, phonophobia, and functional disability, but is associated with increased adverse events.
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sumatriptan subcutaneous route of administration for acute migraine attacks in adults
Cochrane Database of Systematic Reviews, 2012Co-Authors: Christopher J Derry, Sheena Derry, Andrew R MooreAbstract:Background Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. Subcutaneous administration may be preferable to oral for individuals experiencing nausea and/or vomiting Objectives To determine the efficacy and tolerability of subcutaneous sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults. Search methods We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011. Selection criteria We included randomised, double-blind, placebo- and/or active-controlled studies using subcutaneous sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm. Data collection and analysis Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment. Main results Thirty-five studies (9365 participants) compared subcutaneous sumatriptan with placebo or an active comparator. Most of the data were for the 6 mg dose. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 6 mg versus placebo the NNTs were 2.9, 2.3, 2.2, and 2.1 for pain-free at one and two hours, and headache relief at one and two hours, respectively, and 6.1 for sustained pain-free at 24 hours. Results for the 4 mg and 8 mg doses were similar to the 6 mg dose, with 6 mg significantly better than 4 mg only for pain-free at one hour, and 8 mg significantly better than 6 mg only for headache relief at one hour. There was no evidence of increased migraine relief if a second dose of sumatriptan 6 mg was given after an inadequate response to the first. Relief of headache-associated symptoms, including nausea, Photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than placebo. For the most part, adverse events were transient and mild and were more common with sumatriptan than placebo. Sumatriptan was compared directly with a number of active treatments, including other triptans, acetylsalicylic acid plus metoclopramide, and dihydroergotamine, but there were insufficient data for any pooled analyses. Authors' conclusions Subcutaneous sumatriptan is effective as an abortive treatment for acute migraine attacks, quickly relieving pain, nausea, Photophobia, phonophobia, and functional disability, but is associated with increased adverse events.
Stephen D Silberstein - One of the best experts on this subject based on the ideXlab platform.
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lasmiditan is an effective acute treatment for migraine a phase 3 randomized study
Neurology, 2018Co-Authors: Bernice Kuca, Stephen D Silberstein, Linda Wietecha, Paul H Berg, Gregory Dozier, Richard B LiptonAbstract:Objective To assess the efficacy and safety of lasmiditan in the acute treatment of migraine. Methods Adult patients with migraine were randomized (1:1:1) to a double-blind dose of oral lasmiditan 200 mg, lasmiditan 100 mg, or placebo and were asked to treat their next migraine attack within 4 hours of onset. Over 48 hours after dosing, patients used an electronic diary to record headache pain and the presence of nausea, phonophobia, and Photophobia, one of which was designated their most bothersome symptom (MBS). Results Of the 1,856 patients who treated an attack, 77.9% had ≥1 cardiovascular risk factors in addition to migraine. Compared with placebo, more patients dosed with lasmiditan 200 mg were free of headache pain at 2 hours after dosing (32.2% vs 15.3%; odds ratio [OR] 2.6, 95% confidence interval [CI] 2.0–3.6, p p p p Conclusions Lasmiditan dosed at 200 and 100 mg was efficacious and well tolerated in the treatment of acute migraine among patients with a high level of cardiovascular risk factors. ClinicalTrials.gov identifier NCT02439320. Classification of evidence This study provides Class I evidence that for adult patients with migraine, lasmiditan increases the proportion of subjects who are headache pain free at 2 hours after treating a migraine attack.
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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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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.
