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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Rimegepant for Pediatric Migraine

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).
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.
Must not have
History of cluster headache or hemiplegic migraine headache.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours and 48 hours of initial treatment
Awards & highlights
Pivotal Trial

Summary

This trial will test if a new drug, BHV-3000, is safe and effective in treating migraines in children and adolescents.

Who is the study for?
This trial is for children and teens aged 6 to under 18 with a history of migraines, weighing over 40 kg. They must be able to tell the difference between migraine and other headaches, may use stable doses of certain migraine prevention meds but not CGRP antagonists, and should have had 1-8 significant migraine attacks per month in the past two months.
What is being tested?
The study is testing BHV-3000 (Rimegepant) against a placebo for quickly treating moderate or severe migraines in young people. Participants will randomly receive either the actual medication or a dummy pill without knowing which one they are taking.
What are the potential side effects?
While specific side effects aren't listed here, Rimegepant could potentially cause nausea, drowsiness, dry mouth, and allergic reactions among others. Placebos typically have no active ingredients but can still lead to perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 17 years old and will not turn 18 during the study.
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I've had 1-8 severe attacks a month in the last 2 months, lasting over 3 hours.
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I am not using any CGRP antagonist medications like erenumab.
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I weigh more than 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of cluster or hemiplegic migraine headaches.
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I have had a stable mental health condition for at least 6 months.
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I have a history of serious head injury or a neurological condition that could affect my brain function.
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I have had surgery on my stomach or intestines that affects how my body processes food.
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I have or had liver disease or viral hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours and 48 hours of initial treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours and 48 hours of initial treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain
Secondary study objectives
To compare rimegepant with placebo for pain freedom in children and adolescents combined.
To compare rimegepant with placebo for pain freedom in children.
To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief.
+11 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BHV3000 (active drug)Active Control1 Intervention
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Group II: PlaceboPlacebo Group1 Intervention
Matching 75 mg or 50 mg ODT placebo

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,660 Previous Clinical Trials
17,875,227 Total Patients Enrolled
Biohaven Pharmaceutical Holding Company Ltd.Lead Sponsor
8 Previous Clinical Trials
12,334 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,545 Previous Clinical Trials
14,916,392 Total Patients Enrolled

Media Library

Rimegepant/BHV3000 (Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04649242 — Phase 3
Adolescent Health Research Study Groups: BHV3000 (active drug), Placebo
Adolescent Health Clinical Trial 2023: Rimegepant/BHV3000 Highlights & Side Effects. Trial Name: NCT04649242 — Phase 3
Rimegepant/BHV3000 (Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04649242 — Phase 3
Adolescent Health Patient Testimony for trial: Trial Name: NCT04649242 — Phase 3
~700 spots leftby Oct 2026
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