Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study

COL MIG-301 Study Group

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

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< 0.001), similar to those dosed with lasmiditan 100 mg (28.2%; OR 2.2, 95% CI 1.6-3.0, p< 0.001). Furthermore, compared with those dosed with placebo, more patients dosed with lasmiditan 200 mg (40.7% vs 29.5%; OR 1.6, 95% CI 1.3-2.1, p< 0.001) and lasmiditan 100 mg (40.9%; OR 1.7, 95% CI, 1.3-2.2, p< 0.001) were free of their MBS at 2 hours after dosing. Adverse events were mostly mild or moderate in intensity. 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. CLINICALTRIALSGOV 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.

Original languageEnglish (US)
Pages (from-to)e2222-e2232
JournalNeurology
Volume91
Issue number24
DOIs
StatePublished - Dec 11 2018

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Migraine Disorders
Odds Ratio
Confidence Intervals
Headache
Placebos
Therapeutics
Hyperacusis
Photophobia
Nausea
Safety
Pain

ASJC Scopus subject areas

  • Clinical Neurology

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Lasmiditan is an effective acute treatment for migraine : A phase 3 randomized study. / COL MIG-301 Study Group.

In: Neurology, Vol. 91, No. 24, 11.12.2018, p. e2222-e2232.

Research output: Contribution to journalArticle

COL MIG-301 Study Group. / Lasmiditan is an effective acute treatment for migraine : A phase 3 randomized study. In: Neurology. 2018 ; Vol. 91, No. 24. pp. e2222-e2232.
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title = "Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study",
abstract = "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< 0.001), similar to those dosed with lasmiditan 100 mg (28.2{\%}; OR 2.2, 95{\%} CI 1.6-3.0, p< 0.001). Furthermore, compared with those dosed with placebo, more patients dosed with lasmiditan 200 mg (40.7{\%} vs 29.5{\%}; OR 1.6, 95{\%} CI 1.3-2.1, p< 0.001) and lasmiditan 100 mg (40.9{\%}; OR 1.7, 95{\%} CI, 1.3-2.2, p< 0.001) were free of their MBS at 2 hours after dosing. Adverse events were mostly mild or moderate in intensity. 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. CLINICALTRIALSGOV 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.",
author = "{COL MIG-301 Study Group} and Bernice Kuca and Silberstein, {Stephen D.} and Linda Wietecha and Berg, {Paul H.} and Gregory Dozier and Lipton, {Richard B.}",
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T1 - Lasmiditan is an effective acute treatment for migraine

T2 - A phase 3 randomized study

AU - COL MIG-301 Study Group

AU - Kuca, Bernice

AU - Silberstein, Stephen D.

AU - Wietecha, Linda

AU - Berg, Paul H.

AU - Dozier, Gregory

AU - Lipton, Richard B.

PY - 2018/12/11

Y1 - 2018/12/11

N2 - 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< 0.001), similar to those dosed with lasmiditan 100 mg (28.2%; OR 2.2, 95% CI 1.6-3.0, p< 0.001). Furthermore, compared with those dosed with placebo, more patients dosed with lasmiditan 200 mg (40.7% vs 29.5%; OR 1.6, 95% CI 1.3-2.1, p< 0.001) and lasmiditan 100 mg (40.9%; OR 1.7, 95% CI, 1.3-2.2, p< 0.001) were free of their MBS at 2 hours after dosing. Adverse events were mostly mild or moderate in intensity. 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. CLINICALTRIALSGOV 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.

AB - 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< 0.001), similar to those dosed with lasmiditan 100 mg (28.2%; OR 2.2, 95% CI 1.6-3.0, p< 0.001). Furthermore, compared with those dosed with placebo, more patients dosed with lasmiditan 200 mg (40.7% vs 29.5%; OR 1.6, 95% CI 1.3-2.1, p< 0.001) and lasmiditan 100 mg (40.9%; OR 1.7, 95% CI, 1.3-2.2, p< 0.001) were free of their MBS at 2 hours after dosing. Adverse events were mostly mild or moderate in intensity. 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. CLINICALTRIALSGOV 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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