Trial reportCephalalgia : an international journal of headache2019
Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN.
Trial report in Cephalalgia : an international journal of headache, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers, 3 of them syntheses that pooled 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.
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.
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
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)
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Safety and Efficacy of Calcitonin Gene-related Peptide Receptor Antagonists and Selective Serotonin Receptor Agonist in the Management of Migraine: A Systematic Review and Meta-analysis.CNS & neurological disorders drug targets · 2024Pooled it
- Relative efficacy of lasmiditan versus rimegepant and ubrogepant as acute treatments for migraine: network meta-analysis findings.The journal of headache and pain · 2022Pooled it
- Short-term efficacy and safety of lasmiditan, a novel 5-HTThe journal of headache and pain · 2020Pooled it
- Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine.The journal of headache and pain · 2021Trial
- Phase 2 randomized placebo-controlled study of lasmiditan for the acute treatment of migraine in Japanese patients.Headache · 2021Trial
- Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study.Cephalalgia : an international journal of headache · 2021Trial
- Trajectory of migraine-related disability following long-term treatment with lasmiditan: results of the GLADIATOR study.The journal of headache and pain · 2020Trial
- Trial
- Real-World Safety and Effectiveness of Lasmiditan in Patients with Migraine: A Post-Marketing Observational Study in Japan.Neurology and therapy · 2026Article
- Review
- Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices.Pharmaceutical medicine · 2026Review
- Real-World Experience of Lasmiditan for the Acute Treatment of Migraine.Journal of clinical neurology (Seoul, Korea) · 2025Article
- Role of Phytocompounds for Effective Management of Migraine: Current and Future Prospectives.Central nervous system agents in medicinal chemistry · 2025Review
- [New therapeutic era for migraine attacks with recently approved monoclonal antibodies, ditans and gepants].Revista de neurologia · 2024Review
- Drug-related side effects and adverse reactions in the treatment of migraine: a bibliometric and visual analysis.Frontiers in neurology · 2024Article
- The Neuropsychiatric Safety Profile of Lasmiditan: A Comparative Disproportionality Analysis with Triptans.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023Article
- The 5-HTNature reviews. Neurology · 2023Review
- Profile of Lasmiditan in the Acute Treatment of Migraine in Adults: Design, Development, and Place in Therapy.Drug design, development and therapy · 2023Review
- Drug Safety in Episodic Migraine Management in Adults Part 1: Acute Treatments.Current pain and headache reports · 2022Review
- Preventing the Progression of Episodic Migraine to Chronic Migraine with Acute Treatment Optimization.Current pain and headache reports · 2022Review
Corrections and comments
- Erratum issued
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe assessed the safety profile of lasmiditan, a selective 5-HT
methodsSAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses.
resultsThe safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events.
conclusionsAs a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. TRIAL REGISTRATION AT CLINICALTRIALS.GOV: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).
Indexed as
Identifiers
What OpenQuestion holds
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.