Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rimegepant (PF-07899801).
- Who it may be relevant to
- Registry conditions: Acute Treatment of Migraine. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Poland, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Interventions
- Drug Rimegepant (PF-07899801)
Rimegepant 75 mg, 50 mg or 35 mg ODT
Primary outcome measures
- The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities [Time frame: 58 weeks]
Secondary outcome measures (1)
- The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation [Time frame: 58 weeks]
Eligibility criteria
Inclusion criteria
- 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.
- Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 115 centers
- Perseverance Research Center, LLC — Scottsdale
- Physicians Research Group — Tempe
- Advanced Research Center, Inc. — Anaheim
- ProScience Research Group — Culver City
- Neuro-Pain Research Center — Fresno
- Altman Clinical and Translational Research Institute, University of California San Diego — La Jolla
- Adult & Child Neurology Medical Associates — Long Beach
- Memorialcare Miller Children's & Women's Hospital Long Beach — Long Beach
- … and 107 more centers
Poland · 6 centers
Center list to be confirmed — check the primary protocol.
Spain · 3 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04743141 · BHV3000-312 · C4951003 · 2024-512744-32-00