← Back to Search

Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Rimegepant for Pediatric Migraine

Phase 3
Recruiting
Research Sponsored by Biohaven Pharmaceuticals, Inc.
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 before enrollment into the study)
1 or more migraine days requiring treatment during the Observation Phase
Must not have
History of cluster headache or hemiplegic migraine headache
Confounding and clinically significant pain syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 58 weeks
Awards & highlights

Summary

This trial will test if a drug is safe to use for 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 at least 40 kg. They should have experienced 1-8 moderate or severe migraine attacks per month in the last two months and be able to tell migraines apart from other headaches. Stable use of preventive migraine medication is allowed.Check my eligibility
What is being tested?
The study tests the long-term safety of Rimegepant (BHV3000) for treating acute, moderate or severe migraines in young participants. It aims to understand how well they tolerate this medication over an extended period.See study design
What are the potential side effects?
While not specified here, common side effects may include nausea, drowsiness, dry mouth, and potential allergic reactions. Long-term studies like this one help identify any additional risks associated with prolonged use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 17 years old.
Select...
I needed treatment for a migraine at least once during the observation period.
Select...
I've had 1-8 severe attacks a month in the last 2 months.
Select...
I've had 1-8 severe attacks a month in the last 2 months.
Select...
I weigh at least 40 kg.
Select...
I weigh at least 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of cluster or hemiplegic migraine headaches.
Select...
I have severe pain that affects my daily life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~58 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 58 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The occurrence of treatment-emergent adverse events, serious adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rimegepant / BHV3000Experimental Treatment1 Intervention
BHV3000 (rimegepant) 75 mg or 50 mg ODT

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Migraine treatments work through various mechanisms to alleviate symptoms and prevent attacks. CGRP receptor antagonists, such as Rimegepant, block the calcitonin gene-related peptide (CGRP) receptor, which is involved in the transmission of pain and the dilation of blood vessels during a migraine. By inhibiting this pathway, these drugs can reduce the frequency and severity of migraines. Triptans, another common treatment, activate serotonin (5-HT1B/1D) receptors, leading to the constriction of blood vessels and inhibition of inflammatory neuropeptides, providing relief from acute migraine attacks. NSAIDs and acetaminophen work by inhibiting the production of prostaglandins, which are chemicals that promote inflammation, pain, and fever. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate treatment based on the specific pathways involved in their migraine attacks.
Prevention of migraine with monoclonal antibodies against CGRP or the CGRP receptor: Addition to the S1 guideline: Therapy of migraine attacks and prevention of migraine. Recommendations of the Germany Society of Neurology and the German Migraine and Headache Society.Calcitonin gene-related peptide receptor antagonists for migraine.

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
37,088 Total Patients Enrolled
14 Trials studying Migraine
19,250 Patients Enrolled for Migraine
PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,570 Total Patients Enrolled
24 Trials studying Migraine
25,082 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,179 Total Patients Enrolled
19 Trials studying Migraine
18,609 Patients Enrolled for Migraine

Media Library

Rimegepant / BHV3000 (Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04743141 — Phase 3
Migraine Research Study Groups: Rimegepant / BHV3000
Migraine Clinical Trial 2023: Rimegepant / BHV3000 Highlights & Side Effects. Trial Name: NCT04743141 — Phase 3
Rimegepant / BHV3000 (Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743141 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT04743141 — Phase 3
~23 spots leftby Dec 2024