Studies how well rimegepant works for migraine attacks and how well it is tolerated
Studies rimegepant, a tablet for migraine attacks, in adults with migraine.
Key facts
- Who runs it
- University of Florence
- Where
- Florence and Pavia, ItalySee the 2 sites
- Trial code
- Registry title
- Gepant treAtments: EffectIveNess and tolERability (GAINER)
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 15 Jun 2023
- Planned end
- 15 Sept 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Rimegepant 75 MG Disintegrating Oral Tablet
- Record updated
- 21 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with episodic or chronic migraine, with or without aura. It studies how well rimegepant works and how well it is tolerated for treating migraine attacks.
- Age
- 18 years or older
- Sex
- Men and women can both join
- Disease stage
- Migraine without aura, migraine with aura, or chronic migraine, diagnosed by ICHD-III, with at least 3 MMDs
Main reasons for not taking part
- Contraindications for use of gepants
- Other medical diseases or comorbidities that might interfere with the study
- Pregnancy
- Breastfeeding
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III)
- At least 3 MMDs
- Good compliance to study procedures
- Availability of headache diary at least of the preceding months before enrollment
Who cannot take part
- Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments
- Subjects with contraindications for use of gepants
- medical comorbidities that could interfere with study results
- Pregnancy and breastfeeding
Where in Italy
- SOD Centro Cefalee e Farmacologia Clinica, AOU CareggiFlorence, ItalyContact: Luigi F Iannone, MDTaking people
- IRCCS National Neurological Institute "C. Mondino" FoundationPavia, ItalyContact: Roberto De Icco, MDTaking people
About the trial
What the trial wants to find out
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as acute migraine treatment in a cohort of episodic or chronic migraine patients.
The 2 groups in the trial
- Episodic migraine
Patients affected by an episodic pattern migraine(\< 15 monthly headache days) with or without aura according to ICHD-III criteria.
Treatment: Rimegepant 75 MG Disintegrating Oral Tablet
- Chronic migraine
Patients affected by chronic migraine according to ICHD-III criteria.
Treatment: Rimegepant 75 MG Disintegrating Oral Tablet
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)
- Plain-language title
- Studies how well rimegepant works for migraine attacks and how well it is toleratedGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Effectiveness and safety of lasmiditan and rimegepant in the acute migraine treatment: an indirect real-world comparison.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2026
- Record updated
- 21 January 2026