Observational studyThe journal of headache and pain2025
Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study).
Observational study in The journal of headache and pain, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05903027 (Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment), which is not on this map. Cited by 7 papers, 2 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.
Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Rimegepant for the acute treatment of migraine: a systematic review and meta-analysis.The journal of headache and pain · 2026Pooled it
- Efficacy and safety of rimegepant for acute and preventive treatment of migraine: a systematic review and meta-analysis of randomized controlled trials.BMC pharmacology & toxicology · 2026Pooled it
- Effectiveness of Rimegepant for the Acute Treatment of Migraine Among Participants Using Different Types of Preventive Therapy: Analyses from CONFIDENCE.Neurology and therapy · 2026Article
- Retrospective analysis of the tolerability and effectiveness of rimegepant for the acute treatment of migraine in adolescents.Headache · 2026Article
- The efficacy of rimegepant for the acute treatment of vestibular migraine.Scientific reports · 2026Article
- 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
- Evaluating the efficacy of rimegepant as a preventive treatment for chronic and episodic migraine: a three-month longitudinal retrospective cohort study.Frontiers in neurologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRimegepant, a novel oral calcitonin gene-related peptide receptor antagonist, has been recently approved for the acute migraine treatment. While its efficacy was confirmed in randomized clinical trials, no data is available regarding real-life effectiveness and tolerability. GAINER, a prospective, multicentric study, aimed to evaluate rimegepant effectiveness and tolerability in the real-world setting.
methodsOur study involved 16 headache centers across Italy. The main outcomes were: i) 2 h pain freedom, and ii) occurrence of treatment-emergent adverse events after administration. Participants were instructed to treat one migraine attack with rimegepant 75 mg orally disintegrating tablet. Using an ad hoc diary, participants prospectively collected migraine attack features at baseline and every 30 min after rimegepant administration, up to 2 h post dose. A 24 h follow up was also collected.
resultsWe enrolled 103 participants with migraine (74.8% female, mean age 44.4 [42.0 - 46.7] years, 24.3% with chronic migraine of whom 44.0% presented a concomitant diagnosis of medication overuse headache). The number of previously failed preventive classes was 2.7 [2.3 - 3.2]. Participants presented a mean of 9.6 [8.2 - 10.9] monthly migraine days at baseline. At rimegepant intake, 40.8% of patients rated migraine intensity as severe. Pain freedom 2 h post dose was reported in 44.7% (46/103) of individuals. Pain freedom 2 h post dose was not influenced by baseline pain severity (p = 0.316), but it was associated with timing of intake (p = 0.032) with a higher rate of 2 h pain freedom when rimegepant was taken within 1 h from pain onset. Mild adverse events were reported in 15.5% total attacks (16/103), predominantly fatigue (n = 6), gastrointestinal symptoms (n = 6), somnolence (n = 4), and transient cognitive difficulties (n = 3). Tolerability was rated as good-to-excellent in 85.4% cases (88/103).
conclusionsOur data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants that includes subjects with episodic or chronic migraine, medication overuse and a high number of prior preventive treatment failures.
trial registrationThe study was preregistered on clinicaltrial.gov, NCT05903027.
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.