Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Recruiting
Phase 3
Interventional Study
Acute Treatment of Migraine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- Pfizer · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
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 …
Contacts