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
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.