RecruitingAcute Treatment of Migraine

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Eligible age

6–17 yrs

Accepts

All genders

Locations

33 states

Healthy volunteers

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About this study

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).

Sponsor: Pfizer

You may qualify if…

✓ 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. 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).

You may not qualify if…

✕ 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.