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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours and 48 hours of initial treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours and 48 hours of initial treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours and 48 hours of initial treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
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 moreTrial 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
4,583 Previous Clinical Trials
14,633,433 Total Patients Enrolled
Biohaven Pharmaceutical Holding Company Ltd.Lead Sponsor
8 Previous Clinical Trials
12,092 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,488 Previous Clinical Trials
11,810,384 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 6 and 17 years old and will not turn 18 during the study.I have had a stable mental health condition for at least 6 months.I have had or will have surgery with general anesthesia less than 8 weeks before the screening.I have had surgery on my stomach or intestines that affects how my body processes food.I have had migraines for more than 6 months.I've had 1-8 severe attacks a month in the last 2 months, lasting over 3 hours.I can have blood drawn without difficulty.I am not using any CGRP antagonist medications like erenumab.My migraine prevention medication dose has been stable for 12 weeks.You have a history of trying to harm yourself or have a serious mental illness.I stopped taking my preventive migraine medication over 90 days ago.I do not have uncontrolled high blood pressure, diabetes, or life-threatening allergies.I am on one medication that might prevent migraines, but it's not a CGRP antagonist.I have a history of serious head injury or a neurological condition that could affect my brain function.I weigh more than 40 kg.You can explain the difference between a migraine and other kinds of headaches in words.I do not have severe pain that would stop me from joining this study.I have a history of cluster or hemiplegic migraine headaches.I have been on a stable dose of migraine prevention medication for at least 12 weeks.I am on one medication that might prevent migraines, but it's not a CGRP antagonist.I am between 6 and 17 years old and will not turn 18 during the study.You can explain the difference between migraines and other types of headaches using words.I can have blood drawn without difficulty.I stopped taking my preventive migraine medication over 90 days ago.I have or had liver disease or viral hepatitis.
Research Study Groups:
This trial has the following groups:- Group 1: BHV3000 (active drug)
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Adolescent Health Patient Testimony for trial: Trial Name: NCT04649242 — Phase 3
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