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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Subject has at least a 6 month history of migraine (with or without aura) and including the following: 3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
  • 14 or less headache days per month during the 3 month period prior to the Screening Visit
  • 6 or more migraine days during the Observation Period
  • 14 or less headache days during the Observation Period
  • 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
  • Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
  • Migraine attacks, on average, lasting 4 - 72 hours if untreated
  • 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 be able to join if…

• Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
• The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
• The subject has a history or diagnosis of complications of migraine
• The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
• 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.
• History of suicidal behavior or the subject is at risk of self-harm or harm to others.
• History of major psychiatric disorder.
• The subject has a current diagnosis or history of substance abuse
• The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

Where this trial is running

• The Belinga Clinic, Fort Smith, Arkansas, United States
• Advanced Investigative Medicine, Inc., Hawthorne, California, United States
• Velocity Clinical Research San Diego, La Mesa, California, United States
• Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States
• Advanced Neurosciences Research, LLC, Fort Collins, Colorado, United States
• Velocity Clinical Research, Washington DC, Washington D.C., District of Columbia, United States
• Accel Research Sites Network - Edgewater Clinical Research Unit, Edgewater, Florida, United States
• Direct Helpers Research Center, Hialeah, Florida, United States
• New Med Research, Inc, Hollywood, Florida, United States
• Complete Health Research, Ormond Beach, Florida, United States
• D&H Tamarac Research Center LLC, Tamarac, Florida, United States
• Santos Research Center, CORP, Tampa, Florida, United States

+ 78 more sites.

Who to contact

Pfizer Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05156398.