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Testing a new treatment for migraines in children and adolescents

Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Phase 3 Interventional Pfizer · NCT04649242

This study is testing a new migraine medication for kids and teens to see if it helps them feel better compared to a sugar pill.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2100 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionserenumab, fremanezumab
Locations249 sites (Birmingham, Alabama and 248 other locations)
Trial IDNCT04649242 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of BHV-3000, a medication for treating moderate to severe migraines, compared to a placebo in children and adolescents. Participants will have a history of migraines and will be monitored for their response to the treatment over a specified period. The study aims to determine if BHV-3000 can provide relief from migraine symptoms more effectively than a placebo. The trial is designed to adhere to strict eligibility criteria to ensure the safety and relevance of the findings.

Who should consider this trial

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

Not a fit: Patients who do not experience migraines or have mild migraine symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of migraines in pediatric patients.

How similar studies have performed: Previous studies have shown promise in treating migraines with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.
3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.

   1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
   2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
   3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
4. Verbally distinguish between migraine and other types of headaches.
5. Participants must have a weight \> 40 kg at the Screening Visit.
6. Adequate venous access for blood sampling.
7. Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).

Exclusion Criteria:

1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
3. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
4. History of suicidal behavior or major psychiatric disorder.
5. Current diagnosis or history of substance abuse; positive drug test at Screening.
6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
7. Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
9. Current diagnosis of viral hepatitis or a history of liver disease.
10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Where this trial is running

Birmingham, Alabama and 248 other locations

+199 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 Pediatric MigraineMigraineAcute treatmentPhonophobiaPhotophobiaNauseaPediatricChildren
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.