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Long-term safety of rimegepant for treating migraines in children

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

Phase 3 Interventional Pfizer · NCT04743141

This study is testing the long-term safety of rimegepant, a migraine medication, for children and teens aged 6 to under 18 who have frequent migraine attacks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorPfizer Industry-sponsored
Locations64 sites (Anaheim, California and 63 other locations)
Trial IDNCT04743141 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety of rimegepant, a medication for the acute treatment of migraines, specifically in pediatric patients aged 6 to less than 18 years. Participants must have a history of migraines and experience a certain number of moderate to severe attacks monthly. The study aims to gather data on the safety profile of rimegepant over an extended period, ensuring that it is a viable treatment option for children and adolescents suffering from migraines.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6 to less than 18 years with a history of migraines and a specific frequency of migraine attacks.

Not a fit: Patients with cluster headaches or hemiplegic migraines, as well as those with uncontrolled psychiatric conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective treatment option for children and adolescents suffering from acute migraines.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating migraines, but this specific focus on pediatric patients is less common.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. History of migraine (with or without aura) for ≥ 6 months before Screening.
2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
3. 1 or more migraine days requiring treatment during the Observation Phase.
4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
5. Ability to distinguish between migraine and other types of headaches.
6. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg.
7. Adequate venous access for blood sampling.
8. Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).

Exclusion Criteria:

1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome.
3. 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).
4. History of suicidal behavior or at risk of self-harm/harm to others.
5. History of major psychiatric disorder.
6. Current diagnosis or history of substance abuse
7. Reported current use of or tested positive at Screening for drugs of abuse.

Where this trial is running

Anaheim, California and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Treatment of MigraineLong-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.