Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition

Hc, Diener; Tassorelli, Cristina; Dodick, David W.; Silberstein, Stephen D.; Lipton, Richard B.; Ashina, Messoud; Becker, Werner J.; Ferrari, Michel D.; Goadsby, PJ; Pozo‐Rosich, Patricia; Wang, Shuu Jiun; Mandrekar, Jayawant

doi:10.1177/0333102419828967

Cited by 178 publications

(247 citation statements)

References 144 publications

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“…The proportion of a study population taking rescue medication at 2 hours can be a useful secondary efficacy measure, reflecting the patient's judgement of the efficacy of the investigational drug. 9 In the present study, of those patients taking lasmiditan as first dose (any dose), 68% had mild, moderate or severe pain at 2 hours (versus 82% for placebo as first dose); of those patients with pain at 2 hours, 48% took a second dose for rescue (versus 66% for placebo as first dose).…”

Section: Discussionmentioning

confidence: 52%

Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: Findings from the Phase 3 trials (SAMURAI and SPARTAN)

Loo¹,

Plato

Turner³

et al. 2019

Preprint

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Background We studied the efficacy and safety of a second dose of lasmiditan for acute treatment of migraine. Methods SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies in which individuals with migraine were randomized to oral lasmiditan 50mg (SPARTAN only), 100mg, 200mg, or placebo. Study drug was to be taken within 4 hours (h) of onset of a migraine attack (moderate or severe pain). A second dose of study drug was provided for rescue (patient not pain-free at 2h and took a second dose 2-24h post-first dose) or recurrence (patient pain-free at 2h, but experienced recurrence of mild, moderate, or severe migraine pain and took a second dose 2-24h after first dose). Randomization to second dose occurred at baseline; patients originally assigned lasmiditan were randomized to the same lasmiditan dose or placebo (2:1 ratio), and those originally assigned placebo received placebo. Data from SAMURAI and SPARTAN were pooled for efficacy and safety assessment of a second dose of lasmiditan. Results The proportion of patients taking a second dose was lower with lasmiditan versus placebo, and decreased with increasing lasmiditan dose; the majority who took a second dose did so for rescue. In patients taking lasmiditan as first dose, outcomes (pain free, most bothersome symptom [MBS] free) at 2h after a second dose for rescue were similar whether the second dose was lasmiditan or placebo (p>0.05 in all cases). In patients taking lasmiditan for first dose, outcomes at 2h after a second dose for recurrence were as follows: lasmiditan pooled versus placebo - pain free, 50% vs 32% (p>0.05); MBS free, 71% vs 41% (p=0.02); pain relief, 77% vs 52% (p=0.03). In patients whose first dose was lasmiditan, the incidence of treatment emergent adverse events (TEAEs) reported after the second dose was similar whether second dose was lasmiditan or placebo. Conclusions A second dose of lasmiditan showed some evidence of efficacy when taken for headache recurrence. There was no clear benefit of a second dose of lasmiditan for rescue treatment. The incidences of TEAEs were similar whether the second dose was lasmiditan or placebo.

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Section: Discussionmentioning

confidence: 52%

Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: Findings from the Phase 3 trials (SAMURAI and SPARTAN)

Loo¹,

Plato

Turner³

et al. 2019

Preprint

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“…1,17 The presence or absence of migraineassociated symptoms (photophobia, phonophobia, and nausea) was recorded at baseline. Patients recorded migraine headache pain using a 4-point International Headache Society pain severity rating scale (none, mild pain, moderate pain, and severe pain).…”

Section: Methodsmentioning

confidence: 99%

“…Pain relief was defined as experiencing moderate or severe pain at baseline that became mild or none, or mild pain at baseline that became none at the summarized time point. 1,17 The presence or absence of migraineassociated symptoms (photophobia, phonophobia, and nausea) was recorded at baseline. Freedom from these associated symptoms at summarized time points was analyzed in patients who reported the respective symptom at baseline.…”

Section: Studymentioning

confidence: 99%

“…Early relief of migraine symptoms and related disability are among the most important and widely measured benefits of acute migraine treatment. [1][2][3] This has been demonstrated in surveys of patients and their clinicians about treatment needs, multi-attribute decision modeling, and post hoc analysis of clinical trial data examining predictors of satisfaction with treatment and willingness-to-pay methods. [3][4][5] Studies assessing patients' preference for migraine medication efficacy highlight their desire to have an onset of response as early as 30 minutes after an orally administered treatment.…”

Section: Introductionmentioning

confidence: 99%

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Onset of Efficacy Following Oral Treatment With Lasmiditan for the Acute Treatment of Migraine: Integrated Results From 2 Randomized Double‐Blind Placebo‐Controlled Phase 3 Clinical Studies

et al. 2019

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Objective To expand on available information on the efficacy of oral lasmiditan for the acute treatment of migraine with particular focus on the timing of the effect and on its impact on migraine‐associated symptoms. Background Lasmiditan is a novel selective 5‐hydroxytryptamine 1F receptor agonist that lacks vasoconstrictive activity. In 2 phase 3 studies, SAMURAI and SPARTAN, lasmiditan met primary and key secondary efficacy endpoints at 2 hours following initial dose. Methods Integrated analyses were completed from 2 phase 3 clinical trials, SPARTAN and SAMURAI. Baseline data and data collected every 30 minutes up to 2 hours after taking lasmiditan (50, 100, or 200 mg) or placebo were analyzed to determine the onset of efficacy. A total of 5236 patients were randomized to be treated with placebo (N = 1493), lasmiditan 50 mg (N = 750), lasmiditan 100 mg (N = 1498), or lasmiditan 200 mg (N = 1495). Data were analyzed to determine the onset of improvement for the following efficacy measures: pain freedom, most bothersome symptom freedom, pain relief, freedom from associated individual symptoms (photophobia, phonophobia, or nausea), total migraine freedom (defined as pain freedom and freedom from associated symptoms), and freedom from migraine‐related functional disability. Time to meaningful headache relief and time to first become pain free were also analyzed. Results Significantly higher rates of pain freedom (100 mg, 10.0%, P = .012; 200 mg, 15.5%, P < .001; Placebo, 7.0%) and total migraine freedom (100 mg, 8.9%, P = .017; 200 mg, 12.4%, P < .001; Placebo, 6.1%) were achieved starting at 60 minutes in 100‐ and 200‐mg lasmiditan‐treated groups compared with placebo group. Rates of freedom from most bothersome symptom (100 mg, 11.1%, P = .015; 200 mg, 13.0%, P < .001; Placebo, 7.9%), and pain relief (100 mg, 17.5%, P = .007; 200 mg, 19.1%, P < .001; Placebo, 13.4%) were significantly higher starting as early as 30 minutes in lasmiditan 100‐ and 200‐mg lasmiditan‐treated groups. A significantly higher percentage of patients in the 200‐mg lasmiditan‐treated group achieved freedom from photophobia (13.7%, P = .005; Placebo, 9.2%) and phonophobia (17.4%, P = .042; Placebo, 13.4%) starting at 30 minutes. A significantly greater proportion of patients in the 200‐mg lasmiditan‐treated group achieved freedom from migraine‐related functional disability starting at 60 minutes (16.4%, P < .001; Placebo, 11.1%). All efficacy measures, except for freedom from nausea, were statistically significant after lasmiditan treatment (50, 100, or 200 mg) compared with placebo at 90 and 120 minutes. Finally, patients taking lasmiditan had a higher likelihood of achieving meaningful headache relief and becoming headache pain free within 24 hours compared with those taking placebo (P < .001). Conclusions Patients treated with lasmiditan for a migraine attack reported an earlier onset of efficacy compared with those treated with placebo. Some of the efficacy measures such as pain relief demonstrated improvement as early as the first asse...

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“…Dieses Prinzip wurde dann erstmalig in einer Studie zu Wirksamkeit von Topiramat umgesetzt [29]. Die neuen Leitlinien der IHS zu Prophylaxestudien bei Migräne haben diese Erkenntnis aufgenommen [30].…”

Section: Studiendesignsunclassified

Tops und Flops der Kopfschmerztherapie

Diener¹,

Limmroth²,

Gaul³

2019

Nervenheilkunde

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ZUSAMMENFASSUNGDie Therapie akuter Migräneattacken und die Prophylaxe der Migräne wurde durch Fortschritte in den Erkenntnissen der Pathophysiologie der Migräne und die Entwicklung neuer Substanzklassen in den letzten 30 Jahren dramatisch verbessert. Dazu gehört die Einführung der Triptane. Antagonisten gegen Substanz-P waren allerdings nicht wirksam. In der Migräneprophylaxe waren neben den etablierten Medikamenten auch Topiramat und bei der chronischen Migräne Onabotulinumtoxin A wirksam. Neue Ansätze ergeben sich durch die neuen monoklonalen Antikörper gegen CGRP oder den CGRP-Rezeptor. Wichtige Fortschritte gab es in der Epidemiologie und Therapie des chronischen Kopfschmerzes durch Übergebrauch von Schmerz- oder Migränemittel. Patienten mit diesem Krankheitsbild sollten bevorzugt in Schwerpunktpraxen oder Kopfschmerzzentren behandelt werden.

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Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition

Cited by 178 publications

References 144 publications

Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: Findings from the Phase 3 trials (SAMURAI and SPARTAN)

Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: Findings from the Phase 3 trials (SAMURAI and SPARTAN)

Onset of Efficacy Following Oral Treatment With Lasmiditan for the Acute Treatment of Migraine: Integrated Results From 2 Randomized Double‐Blind Placebo‐Controlled Phase 3 Clinical Studies

Tops und Flops der Kopfschmerztherapie

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