Long-term safety of rimegepant for migraine in children and teens
Tests long-term safety of rimegepant for acute migraine in children aged 6 to 17.
Plain-language title generated from the registry record
Registry title: Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Key facts
- Where
- Barcelona, Sevilla, and Valladolid, SpainSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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 children and teenagers aged 6 to under 18 who have migraine and need treatment for attacks. It tests the long-term safety of rimegepant.
- Age
- 6 to under 18 years (must not turn 18 on or before the Baseline visit).
- Sex
- Boys and girls can both join.
- Disease stage
- Migraine, with or without aura, for at least 6 months. 1 to 8 moderate or severe attacks per month in the 2 months before screening.
- Earlier treatment
- Migraine prevention medicine is allowed if the dose has been stable for at least 12 weeks before the Screening Visit.
Main reasons for not taking part
- History of cluster headache or hemiplegic migraine headache
- Another clinically significant pain syndrome
- Uncontrolled or untreated psychiatric condition, or history of psychosis or mania
- History of suicidal behavior or risk of self-harm or harm to others
- Current or past substance abuse, or positive test for drugs of abuse
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT04743141, who can take part
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpainTaking people
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?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT04743141EU 2024-512744-32-00
- Record updated
- 27 October 2026
- Original description
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to < 18 years of age).Read full original descriptionShow less
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to < 18 years of age).
Inclusion: History of migraine (with or without aura) for ≥ 6 months before Screening; History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening; 1 or more migraine days requiring treatment during the Observation Phase; Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit; Ability to distinguish between migraine and other types of headaches; Weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg; Adequate venous access for blood sampling; Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
Exclusion: Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded); Reported current use of or tested positive at Screening for drugs of abuse; History of cluster headache or hemiplegic migraine headache; Confounding and clinically significant pain syndrome; History of suicidal behavior or at risk of self-harm/harm to others; History of major psychiatric disorder; Current diagnosis or history of substance abuse.