RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Rimegepant (PF-07899801) for Acute Treatment of Migraine

This study wants to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).

Official registry: https://clinicaltrials.gov/study/NCT04743141 · Pfizer · enrollment listed as 600

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 (PF-07899801). The registry lists allocation as na. This study wants to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).

They plan to enroll about 600 people at 122 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Interventions: Rimegepant (PF-07899801)

Primary outcome (registry wording): The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities

Who it is for (from inclusion criteria)

Ages 6 Years to 17 Years
History of migraine (with or without aura) for ≥ 6 months before Screening
History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening
1 or more migraine days requiring treatment during the Observation Phase
Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit
Ability to distinguish between migraine and other types of headaches
Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg
Adequate venous access for blood sampling

Who the registry excludes

History of cluster headache or hemiplegic migraine headache
Confounding and clinically significant pain syndrome
Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded)
History of suicidal behavior or at risk of self-harm/harm to others
History of major psychiatric disorder
Current diagnosis or history of substance abuse
Reported current use of or tested positive at Screening for drugs of abuse

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

122 listed

Perseverance Research Center, LLC — Scottsdale, Arizona (recruiting)
Physicians Research Group — Tempe, Arizona (active_not_recruiting)
Advanced Research Center, Inc. — Anaheim, California (recruiting)
ProScience Research Group — Culver City, California (active_not_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)
Memorialcare Miller Children's & Women's Hospital Long Beach — Long Beach, California (recruiting)
Velocity Clinical Research - North Hollywood — North Hollywood, California (active_not_recruiting)
The Neurology Group — Pomona, California (recruiting)
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy — Sacramento, California (active_not_recruiting)
University of California, Davis Clinical and Translational Science Center Clinical Research Center — Sacramento, California (active_not_recruiting)

+ 9 sites outside the US on the same record

Related recruiting trials in this snapshot

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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.

NCT04649242 · Official ClinicalTrials.gov record · Pfizer

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Phase 3: testing Eptinezumab for Chronic Migraine in Children

To find out if eptinezumab is better than dummy treatment (placebo) (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

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 NCT04743141 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 NCT04743141?

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 NCT04743141?

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