RecruitingMigraine

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

Eligible age

6–17 yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

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About this study

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.

Sponsor: Pfizer

You may qualify if…

✓ 1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
✓ 1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
✓ 2. 6 or more migraine days during the Observation Period
✓ 3. 14 or less headache days during the Observation Period
✓ 4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
✓ 5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
✓ 6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
✓ 7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent.

You may not qualify if…

✕ 1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
✕ 2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
✕ 3. The subject has a history or diagnosis of complications of migraine
✕ 4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
✕ 5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
✕ 6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
✕ 7. History of major psychiatric disorder.
✕ 8. The subject has a current diagnosis or history of substance abuse