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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT05156398

Run by

Pfizer

People needed

640

Starts

2022-02-28

Expected to finish

2032-11-27

Last updated by the study team

2026-07-29

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has at least a 6 month history of migraine (with or without aura) and including the following:
• 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.
• Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.

You may not qualify 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 it is running

• Alina Clinical Trials, LLC. — Dallas, Texas, United States (enrolling)
• SCLA Management Office — Houston, Texas, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Avera Medical Group Pediatrics - Dawley Farm — Sioux Falls, South Dakota, United States (enrolling)
• Velocity Clinical Research, Washington DC — Washington D.C., District of Columbia, United States (enrolling)
• SCLA Management - Drop Box — Houston, Texas, United States (enrolling)
• Papillion Research Center/CCT Research — Papillion, Nebraska, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Avera Research Institute — Sioux Falls, South Dakota, United States (enrolling)
• D&H Tamarac Research Center LLC — Tamarac, Florida, United States (enrolling)
• Santos Research Center, CORP — Tampa, Florida, United States (enrolling)
• Augusta University — Augusta, Georgia, United States (enrolling)
• North Texas Center for Clinical Research — Frisco, Texas, United States (enrolling)
• DM Clinical Research - Cy Fair — Houston, Texas, United States (enrolling)
• Direct Helpers Research Center — Hialeah, Florida, United States (enrolling)
• Velocity Clinical Research, Grand Island — Grand Island, Nebraska, United States (enrolling)
• Northwest Clinical Trials, Inc. — Boise, Idaho, United States (enrolling)
• Advanced Investigative Medicine, Inc. — Hawthorne, California, United States (enrolling)
• Nola Research Works, LLC — New Orleans, Louisiana, United States (enrolling)
• Avera McKennan Hospital & University Health Center — Sioux Falls, South Dakota, United States (enrolling)
• Roy Blunt NextGen Precision Health Building — Columbia, Missouri, United States (enrolling)
• University of Missouri Health Care - Investigation Pharmacy — Columbia, Missouri, United States (enrolling)
• University of Missouri-Clinical and Translational Sciences Unit — Columbia, Missouri, United States (enrolling)
• University of Missouri — Columbia, Missouri, United States (enrolling)
• NeuroCare Plus — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.