RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Rimegepant/BHV3000 for Pediatric Migraine

Q: Is NCT04649242 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT04649242?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT04649242?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This study wants to test the safety and how well it works of BHV-3000 versus dummy treatment (placebo) in the acute treatment of moderate or severe migraine in children and adolescents.

Official registry: https://clinicaltrials.gov/study/NCT04649242 · Pfizer · enrollment listed as 2,100

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Rimegepant/BHV3000, or Matching placebo. The registry lists allocation as randomized. This study wants to test the safety and how well it works of BHV-3000 versus dummy treatment (placebo) in the acute treatment of moderate or severe migraine in children and adolescents.

They plan to enroll about 2,100 people at 245 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Interventions: Rimegepant/BHV3000, Matching placebo

Primary outcome (registry wording): To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.

Who it is for (from inclusion criteria)

Ages 6 Years to 17 Years
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
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
Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases
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 Visit
Verbally distinguish between migraine and other types of headaches
Participants must have a weight \> 40 kg at the Screening Visit

Who the registry excludes

History of cluster headache or hemiplegic migraine headache
Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study
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
History of suicidal behavior or major psychiatric disorder
Current diagnosis or history of substance abuse; positive drug test at Screening
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
Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit

Public study contact (from the registry)

Pfizer Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

245 listed

Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama — Birmingham, Alabama (active_not_recruiting)
Perseverance Research Center, LLC — Scottsdale, Arizona (recruiting)
Physicians Research Group — Tempe, Arizona (active_not_recruiting)
Advanced Research Center, Inc. — Anaheim, California (recruiting)
Adult & Child Neurology Medical Associates — Costa Mesa, California (recruiting)
ProScience Research Group — Culver City, California (active_not_recruiting)
Memorial Health Services — Fountain Valley, California (recruiting)
Neuro-Pain Research Center — Fresno, California (recruiting)
Altman Clinical and Translational Research Institute, University of California San Diego — La Jolla, California (recruiting)
Adult & Child Neurology Medical Associates — Long Beach, California (recruiting)
Miller Children's & Women's Hospital Long Beach — Long Beach, California (recruiting)
National Research Institute — Los Angeles, California (active_not_recruiting)

+ 77 sites outside the US on the same record

Related recruiting trials in this snapshot

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NCT04743141 · Official ClinicalTrials.gov record · Pfizer

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Phase 3: testing Eptinezumab for Chronic Migraine in Children

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NCT04965675 · Official ClinicalTrials.gov record · H. Lundbeck A/S

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Not a traditional drug phase: Rimegepant for Migraine

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

NCT05046613 · Official ClinicalTrials.gov record · Pfizer

FAQ about this NCT record

Is NCT04649242 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04649242?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04649242?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary