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Preventing migraines in children with rimegepant

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

Phase 3 Interventional Pfizer · NCT05156398

This study is testing if a new medication called rimegepant can help kids and teens aged 6 to 17 who get migraines by reducing how often they have them and improving their quality of life.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment640 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorPfizer Industry-sponsored
Locations90 sites (Fort Smith, Arkansas and 89 other locations)
Trial IDNCT05156398 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of rimegepant compared to a placebo for preventing migraines in children and adolescents aged 6 to under 18 years who experience episodic migraines. Participants must have a history of migraines and meet specific criteria regarding the frequency and severity of their headaches. The study aims to determine if rimegepant can reduce the number of migraine days and improve overall quality of life for young patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6 to 17 years with a documented history of episodic migraines.

Not a fit: Patients who do not have a history of migraines or those with chronic migraine conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of migraines in pediatric patients.

How similar studies have performed: Previous studies have shown promising results for migraine prevention in adults using similar treatments, but this specific approach in pediatric populations is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:

   1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
   2. 6 or more migraine days during the Observation Period
   3. 14 or less headache days during the Observation Period
   4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
   5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
   6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
   7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent.

      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.

Exclusion Criteria:

1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
7. History of major psychiatric disorder.
8. The subject has a current diagnosis or history of substance abuse
9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

Where this trial is running

Fort Smith, Arkansas and 89 other locations

+40 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 MigraineMigraine preventionPhonophobiaPhotophobiaNauseaPediatric migraineAdolescent migraine
Last reviewed 2026-06-13 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.