At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Rimegepant/BHV3000 (drug), Matching placebo (drug)
- How long the study runs
- Study runs about 96 months (dates as stated)
- About the drug or intervention
- Rimegepant/BHV3000 — drug: BHV3000 (rimegepant) 75 mg or 50 mg ODT · Matching placebo — drug: Matching 75 mg or 50 mg ODT placebo
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 6 Years to 17 Years
- Who
- All
- Number of participants
- 2,100
- Started
- 2021-01-15
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for pediatric migraine
- • Phase3 - 2,100 participants
- • The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents
Who can take part?
- • Ages 6 Years to 17 Years
- • Diagnosed with pediatric migraine
Where?
- • Leicester - Leicester Royal Infirmary
- • London - Re:Cognition Health Limited
- • London - Great Ormond Street Hospital for Children NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years - 17 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ done so at least 90 days
- ✓ a weight \> 40 kg at the Screening Visit
What the study is looking for
- ✓History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting...
- ✓Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the...
- ✓Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP...
- ✓Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
- ✓Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening...
Who cannot take part
- ✗History of cluster headache or hemiplegic migraine headache.
- ✗Confounding and clinically significant pain syndrome that may interfere with the participant's ability to...
- ✗Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening...
- ✗History of suicidal behavior or major psychiatric disorder.
- ✗Current diagnosis or history of substance abuse; positive drug test at Screening.
See the full criteria
Where Is This Study? (3 UK sites)
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Re:Cognition Health Limited
London W1G 9JF, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700How to Get in Touch
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