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

Korábbi kezelés

• 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).
• Reported current use of or tested positive at Screening for drugs of abuse.

Más betegség

• History of cluster headache or hemiplegic migraine headache.
• Confounding and clinically significant pain syndrome.
• 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

• 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).