Trial reportThe journal of headache and pain2020
Trajectory of migraine-related disability following long-term treatment with lasmiditan: results of the GLADIATOR study.
Trial report in The journal of headache and pain, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- 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
- Lasmiditan for Acute Treatment of Migraine in Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials.CNS drugs · 2020Pooled it
- Efficacy of lasmiditan for the acute treatment of perimenstrual migraine.Cephalalgia : an international journal of headache · 2022Trial
- Effectiveness and tolerability of lasmiditan in the acute treatment of migraine: a real-world, prospective, multicentric study (DART study).Therapeutic advances in neurological disorders · 2025Article
- 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
- Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience.Frontiers in neurology · 2023Article
- Dietary fatty acids improve perceived sleep quality, stress, and health in migraine: a secondary analysis of a randomized controlled trial.Frontiers in pain research (Lausanne, Switzerland) · 2023Article
- Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm.The Clinical journal of pain · 2022Article
- Ditans: a new prospective for the therapy of migraine attack?Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022Review
- Lasmiditan and 5-Hydroxytryptamine in the rat trigeminal system; expression, release and interactions with 5-HTThe journal of headache and pain · 2022Article
- New Approaches to Shifting the Migraine Treatment Paradigm.Frontiers in pain research (Lausanne, Switzerland) · 2022Review
- Lasmiditan: Acute Migraine Treatment Without Vasoconstriction. A Review.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2021Review
- Mapping Assessments Instruments for Headache Disorders against the ICF Biopsychosocial Model of Health and Disability.International journal of environmental research and public health · 2020Review
- Lasmiditan for the Treatment of Migraines With or Without Aura in Adults.Psychopharmacology bulletin · 2020Review
- The potential of lasmiditan in migraine.Therapeutic advances in neurological disorders · 2020Review
- Introduction of a smartphone based behavioral intervention for migraine in the emergency department.General hospital psychiatryArticle
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundMigraine is recognized as the second leading cause of disability globally. Lasmiditan is a novel, selective serotonin 5-HT
methodsCompleters of two single-attack parent studies were offered participation in the 1 year GLADIATOR study, that randomized participants to treatment with lasmiditan 100 mg or 200 mg taken as needed for migraine attacks of at least moderate severity. Changes in MIDAS were modeled using a mixed model repeated measures analysis.
resultsThe sample included 1978 patients who received ≥1 lasmiditan dose and were followed for a median of 288 days. Baseline mean MIDAS scores for the lasmiditan 100-mg and 200-mg groups were 29.4 and 28.9, respectively, indicating severe migraine-related disability. Relative to baseline, MIDAS total scores were significantly lower at 3, 6, 9, and 12 months for both dose groups. At 12 months, changes in MIDAS scores were - 12.5 and - 12.2 for lasmiditan 100 mg and 200 mg, respectively, with 49% and 53% of patients, respectively, achieving at least a 50% decrease in MIDAS total score. Statistically significant improvements were also seen for work and/or school absenteeism and presenteeism, monthly headache days, and mean headache pain intensity at all time points up to 1 year. Findings for patients who completed all visits versus those dropping out early were similar. Responses were generally similar for the lasmiditan 100 mg or 200 mg doses, between subgroups defined based on the number of baseline monthly migraine attacks (≤5 vs. >5), and also between subgroups defined by pain-free response (yes/no) during initial attacks.
conclusionsLong-term treatment with lasmiditan was associated with significant reductions in migraine-related disability, including both work or school absenteeism and presenteeism. The similarity of responses in completers and those who dropped out suggests that selective attrition does not account for the improvements. Benefits were significant at 3 months and maintained through 12 months.
trial registrationclinicaltrials.govNCT02565186; first posted October 1, 2015.
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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.