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Looking for participantsPhase3

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Sponsor: Pfizer

NCT ID: NCT04649242

View on ClinicalTrials.gov ↗

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.

Pediatric Migraine

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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 Is This Study? (3 UK sites)

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Re:Cognition Health Limited

London W1G 9JF, United Kingdom

Recruiting

Great Ormond Street Hospital for Children NHS Foundation Trust

London WC1N 3JH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

How to Get in Touch

Pfizer Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09