Evidence map›Paper›PMID 36138260›Full record

Trial reportAdvances in therapy2022

Efficacy of Lasmiditan Across Patient and Migraine Characteristics in Japanese Patients with Migraine: A Secondary Analysis of the MONONOFU Trial.

Takao Takeshima, Mika Komori, Yuka Tanji, Akichika Ozeki, Yoshihisa Tatsuoka

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Real-World Experience of Lasmiditan for the Acute Treatment of Migraine.Journal of clinical neurology (Seoul, Korea) · 2025
    Article
  4. Migraine in men.The journal of headache and pain · 2025
    Review
  5. Article
  6. Review
  7. Article
  8. 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

5 authors at 2 institutions in 1 country.

Takao TakeshimaTominaga Hospital, Osaka, Japan.
Mika KomoriEli Lilly Japan K.K., LILLY PLAZA ONE BLDG. 8F, 5-1-28 Isogamidori, Chuo-Ku, Kobe, 651-0086, Japan. komori_mika@lilly.com.ORCID http://orcid.org/0000-0003-1887-1296
Yuka TanjiEli Lilly Japan K.K., LILLY PLAZA ONE BLDG. 8F, 5-1-28 Isogamidori, Chuo-Ku, Kobe, 651-0086, Japan.
Akichika OzekiEli Lilly Japan K.K., LILLY PLAZA ONE BLDG. 8F, 5-1-28 Isogamidori, Chuo-Ku, Kobe, 651-0086, Japan.
Yoshihisa TatsuokaTatsuoka Neurology Clinic, Kyoto, Japan.
Eli Lilly (Japan) · JPTominaga hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis MONONOFU trial subgroup analysis evaluates the efficacy of lasmiditan across patient and migraine characteristics in Japanese patients with migraine.

methodsMONONOFU trial was a multicenter, randomized, double-blind, placebo-controlled study. The patients were randomly assigned in a 3:7:6:7 ratio to receive lasmiditan 50 mg, 100 mg, 200 mg, or placebo for a single migraine attack within 4 h of pain onset. Efficacy of lasmiditan vs placebo was evaluated at 2 h post dose for proportion of patients with headache pain freedom. Efficacy was assessed across patient characteristics (age, sex, body weight, cardiovascular risk factors (CVRF), and comorbidity of tension-type headache), migraine disease characteristics (history of migraine with aura, migraine prevention therapy, triptan response, and triptan use or nonuse), and migraine attack characteristics (headache severity, aggressive headache, attack during perimenstrual period, time to dosing, time of dosing, experienced treatment-emergent adverse event (TEAE) of dizziness, and experienced TEAE of somnolence). Logistic regression was used; all subgroup analyses were not analyzed with multiplicity-adjusted statistical tests.

resultsTreatment-by-subgroup interactions (by each arm) were not significant (p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups and lasmiditan doses, except for CVRF (100 mg and 200 mg), migraine with aura (50 mg), triptan response (50 mg), and time to dosing (200 mg). Treatment-by-subgroup interactions (by overall) were not significant (p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups, except for CVRFs. Higher proportions of patients were pain free at 2 h post dose when treated with lasmiditan (50 mg, 100 mg, and 200 mg) versus placebo, irrespective of most patient characteristics, migraine disease characteristics, and migraine attack characteristics.

conclusionAlthough few interactions were observed, lasmiditan could be a promising acute treatment option in a wide range of Japanese patients with migraine, as efficacy is not generally influenced by patient and migraine characteristics.

Indexed as

Migraine DisordersMigraine with AuraBenzamidesDouble-Blind MethodHeadacheHumansJapanPiperidinesPyridinesSerotonin Receptor AgonistsTreatment OutcomeTryptaminesBenzamideslasmiditanPiperidinesPyridinesSerotonin Receptor AgonistsTryptaminesEfficacyJapanLasmiditanMigrainePatient and migraine characteristics

Identifiers

PMID36138260
PMCPMC9525364
OpenAlexW4296691560

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.