Status:
RECRUITING
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Lead Sponsor:
Pfizer
Conditions:
Acute Treatment of Migraine
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04743141
Start Date
April 28 2021
End Date
July 31 2030
Last Update
January 7 2026
Active Locations (125)
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1
Perseverance Research Center, LLC
Scottsdale, Arizona, United States, 85253
2
Physicians Research Group
Tempe, Arizona, United States, 85284
3
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
4
ProScience Research Group
Culver City, California, United States, 90230