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โ† Trials
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Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

RecruitingPhase 3Ages 6 Years - 17 YearsAllPfizer
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (โ‰ฅ 6 to \< 18 years of age).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. History of migraine (with or without aura) for โ‰ฅ 6 months before Screening. 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening. 3. 1 or more migraine days requiring treatment during the Observation Phase. 4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit. 5. Ability to distinguish between migraine and other types of headaches. 6. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg. 7. Adequate venous access for blood sampling. 8. 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: 1. History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant pain syndrome. 3. 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). 4. History of suicidal behavior or at risk of self-harm/harm to others. 5. History of major psychiatric disorder. 6. Current diagnosis or history of substance abuse 7. Reported current use of or tested positive at Screening for drugs of abuse.
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What it tests

  • Rimegepant (PF-07899801)
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Where

124 sites
Perseverance Research Center, LLC
Scottsdale, United States
Physicians Research Group
Tempe, United States
Advanced Research Center, Inc.
Anaheim, United States
ProScience Research Group
Culver City, United States
Neuro-Pain Research Center
Fresno, United States
Altman Clinical and Translational Research Institute, University of California San Diego
La Jolla, United States
Adult & Child Neurology Medical Associates
Long Beach, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, United States

โ€ฆand 116 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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