Evidence map›Paper›PMID 30446595›Full record

Trial reportNeurology2018

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

Bernice Kuca, Stephen D Silberstein, Linda Wietecha, Paul H Berg, Gregory Dozier, Richard B Lipton, COL MIG-301 Study Group

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 109 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 12 pooled it
24.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02439320 phase3completednot on this map

A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2016Enrolled2,231ConditionsAcute MigraineArmsLasmiditan 100 mg, Lasmiditan 200 mg, Placebo (matches lasmiditan doses)
NCT06267664 unknown statusnot on this mapstarted 2023, after this paper: background citation

Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP): an International Prospective Multicentric Cohort Study

Typeobservational_patient_registrySponsorHospital Clínico Universitario de ValladolidRan2023 to 2024Enrolled1,500ConditionsMigraine, Migraine Disorders, Migraine With Aura, Headache DisordersArmsPatients with migraine treated with triptans, Lasmiditan or Gepants
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 12 syntheses or guidelines pooled it, 265 citations in OpenAlex.

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  8. The Effect and Safety of 5-HTBioMed research international · 2021
    Pooled it
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  10. Short-term efficacy and safety of lasmiditan, a novel 5-HTThe journal of headache and pain · 2020
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  15. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine.Cephalalgia : an international journal of headache · 2022
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49 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Bernice KucaFrom CoLucid Pharmaceuticals (B.K.), Inc, Cambridge, MA; Thomas Jefferson University (S.D.S.), Philadelphia, PA; Eli Lilly and Company (L.W., P.H.B.), Indianapolis, IN; IQVIA (G.D.), Durham, NC; and Montefiore Headache Center (R.B.L.), Bronx, NY.
Stephen D SilbersteinFrom CoLucid Pharmaceuticals (B.K.), Inc, Cambridge, MA; Thomas Jefferson University (S.D.S.), Philadelphia, PA; Eli Lilly and Company (L.W., P.H.B.), Indianapolis, IN; IQVIA (G.D.), Durham, NC; and Montefiore Headache Center (R.B.L.), Bronx, NY.
Linda WietechaFrom CoLucid Pharmaceuticals (B.K.), Inc, Cambridge, MA; Thomas Jefferson University (S.D.S.), Philadelphia, PA; Eli Lilly and Company (L.W., P.H.B.), Indianapolis, IN; IQVIA (G.D.), Durham, NC; and Montefiore Headache Center (R.B.L.), Bronx, NY. wietecha_linda_a@lilly.com.
Paul H BergFrom CoLucid Pharmaceuticals (B.K.), Inc, Cambridge, MA; Thomas Jefferson University (S.D.S.), Philadelphia, PA; Eli Lilly and Company (L.W., P.H.B.), Indianapolis, IN; IQVIA (G.D.), Durham, NC; and Montefiore Headache Center (R.B.L.), Bronx, NY.
Gregory DozierFrom CoLucid Pharmaceuticals (B.K.), Inc, Cambridge, MA; Thomas Jefferson University (S.D.S.), Philadelphia, PA; Eli Lilly and Company (L.W., P.H.B.), Indianapolis, IN; IQVIA (G.D.), Durham, NC; and Montefiore Headache Center (R.B.L.), Bronx, NY.
Richard B LiptonFrom CoLucid Pharmaceuticals (B.K.), Inc, Cambridge, MA; Thomas Jefferson University (S.D.S.), Philadelphia, PA; Eli Lilly and Company (L.W., P.H.B.), Indianapolis, IN; IQVIA (G.D.), Durham, NC; and Montefiore Headache Center (R.B.L.), Bronx, NY.
COL MIG-301 Study Group
Montefiore Medical Center · USThomas Jefferson University · US

Funding

Vascular Structure and Function in Cognitive AgingP01AG003949 · NIA · YESHIVA UNIVERSITY · PI Jelena Pavlovic · 1985 to 2026
$73.9M
Brain injury due to soccer heading and opportunities for its mitigationR01NS082432 · NINDS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI LIPTON, MICHAEL LAWRENCE · 2013 to 2017
$3.5M
Einstein Center for Excellence for Clinical Trials in NeuroscienceU10NS077308 · NINDS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI LIPTON, RICHARD B., SHINNAR, SHLOMO · 2011 to 2017
$2.2M
Inflammatory Mediators of Stress and Cognitive AgingR01AG042595 · NIA · PENNSYLVANIA STATE UNIVERSITY, THE · PI ENGELAND, CHRISTOPHER G, GRAHAM-ENGELAND, JENNIFER ELISE · 2012 to 2016
$1.6M
The relation of migraine to daily hormone patterns and menopausal stageK23AG049466 · NIA · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI PAVLOVIC, JELENA · 2016 to 2021
$918k
NIA NIH HHS K23 AG049466NIA NIH HHS P01 AG003949NIA NIH HHS R01 AG042595NINDS NIH HHS R01 NS082432NINDS NIH HHS U10 NS077308
6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of lasmiditan in the acute treatment of migraine.

methodsAdult 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).

resultsOf 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,

conclusionsLasmiditan 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.

Indexed as

Acute DiseaseAdministration, OralAdultBenzamidesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPiperidinesPyridinesTreatment OutcomeBenzamideslasmiditanPiperidinesPyridines

Identifiers

PMID30446595
PMCPMC6329326
OpenAlexW2901869599

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.