Evidence map›Paper›PMID 31340760›Full record

Trial reportThe journal of headache and pain2019

Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials.

Li Shen Loo, Jessica Ailani, Jack Schim, Simin Baygani, Hans-Peter Hundemer, Martha Port, John H Krege

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

Trial report in The journal of headache and pain, 2019. 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 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
5.1field-weighted citation impact, top 4% 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)
NCT02605174 phase3completednot on this map

A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2017Enrolled3,005ConditionsMigraine With or Without AuraArmsLasmiditan 50 mg, Lasmiditan 100 mg, Lasmiditan 200 mg, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
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  8. The 5-HTNature reviews. Neurology · 2023
    Review
  9. Review
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  11. Article
  12. Ubrogepant to Treat Acute Migraine in Adults.Neurology international · 2021
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
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  19. Article
  20. The potential of lasmiditan in migraine.Therapeutic advances in neurological disorders · 2020
    Review
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 4 institutions in 2 countries.

Li Shen LooLilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.
Jessica AilaniMedStar Georgetown University Hospital, Washington D.C., USA.
Jack SchimThe Neurology Center of Southern California, Carlsbad, CA, USA.
Simin BayganiLilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.
Hans-Peter HundemerLilly Deutschland GmbH, Medical Department, Bad Homburg, Germany.
Martha PortLilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA. port_martha_diane@lilly.com.ORCID http://orcid.org/0000-0001-6559-1014
John H KregeLilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.
Eli Lilly (United States) · USEli Lilly (Germany) · DEGeorgetown University · USNeurology Center of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo study the efficacy and safety of lasmiditan for acute treatment of migraine in patients using migraine preventive medications.

backgroundWhile lasmiditan has been proven to be an effective acute treatment for migraine, its effectiveness has not been examined when used concurrently with migraine preventives.

methodsSAMURAI and SPARTAN were similarly designed, double-blind, phase 3, placebo-controlled studies of patients 18 years or older with 3 to 8 migraine attacks per month. Patients were randomized to treat a migraine attack with oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo. Migraine preventives were allowed as long as doses were stable for 3 months prior to screening and were unchanged during the study. Preventive medications with established or probable efficacy, as recommended by the American Academy of Neurology, the American Headache Society, and the European Headache Federation, plus botulinum toxin type A and candesartan, were included. Within the subgroups of patients using and not using preventive therapies, lasmiditan and placebo groups were analyzed for the outcome of pain-free at 2 h and other efficacy outcomes. The subgroups of patients using and not using preventive therapies were compared and interaction p-values were calculated for safety and efficacy outcomes.

resultsIn these trials, 698 of 3981 patients (17.5%) used migraine preventive treatments. Among patients using preventives, all lasmiditan doses resulted in significantly more patients being pain-free at 2 h, compared to placebo (p < 0.05). Primary efficacy outcome (pain-free at 2 h), key secondary outcome (most bothersome symptom-free at 2 h) and all other efficacy outcomes were not significantly different between patients using or not using migraine preventives (all interaction p-values ≥0.1). Rates of adverse events were similar for patients using and not using preventive medications.

conclusionsLasmiditan was more effective than placebo for the acute treatment of migraine in patients concurrently using migraine preventive medications. Lasmiditan efficacy and safety measures were similar for patients using and not using preventive medications.

trial registrationSAMURAI (NCT02439320) and SPARTAN (NCT02605174). Registered 18 March 2015.

Indexed as

AdultBenzamidesBenzimidazolesBiphenyl CompoundsBotulinum Toxins, Type ADouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPiperidinesPyridinesTetrazolesTreatment OutcomeBenzamidesBenzimidazolesBiphenyl CompoundsBotulinum Toxins, Type AcandesartanlasmiditanPiperidinesPyridinesTetrazolesAcute treatmentConcomitantDitanEfficacyLasmiditanMigraineMigraine medicationMigraine preventiveMigraine prophylaxis

Identifiers

PMID31340760
PMCPMC6734212
OpenAlexW2962862085

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.