Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: April 28, 2021
End Date: December 31, 2024
Pfizer Pfizer CT.gov Call Center
1-800-718-1021
1-800-718-1021
Inclusion Criteria:
1. History of migraine (with or without aura) for ≥ 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.
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 before enrollment into the study)
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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Conditions:
- Migraine Disorders