Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Recruiting · NCT05156398 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboRimegepant
What this trial 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 take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
60 locations listed across 24 US states.
- 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
- Clinical Trial Office - Augusta, Georgia, United States
- Augusta University - Augusta, Georgia, United States
- WR-Mount Vernon Clinical Research, LLC - Sandy Springs, Georgia, United States
- Meridian Clinical Research, LLC - Savannah, Georgia, United States
- Extraordinary Family Healthcare - Snellville, Georgia, United States
- Renew Health Clinical Research LLC - Snellville, Georgia, United States
- Northwest Clinical Trials, Inc. - Boise, Idaho, United States
- Diamond Headache Clinic - Chicago, Illinois, United States
- Nola Research Works, LLC - New Orleans, Louisiana, United States
- NRST - Detroit - Highland Park, Michigan, United States
- Clinical Research Institute - Minneapolis, Minnesota, United States
- Safe Haven Clinical Research - Clinton, Mississippi, United States
- Roy Blunt NextGen Precision Health Building - Columbia, Missouri, United States
- University of Missouri Health Care - Investigation Pharmacy - Columbia, Missouri, United States
- University of Missouri-Clinical and Translational Sciences Unit - Columbia, Missouri, United States
- University of Missouri - Columbia, Missouri, United States
- Velocity Clinical Research, Grand Island - Grand Island, Nebraska, United States
- Papillion Research Center/CCT Research - Papillion, Nebraska, United States
- Renown Regional Medical Center - Reno, Nevada, United States
- Dent Neurosciences Research Center, Inc. - Amherst, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Carolina Institute for Clinical Research, LLC - Fayetteville, North Carolina, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- Velocity Clinical Research - Cincinnati, Ohio, United States
- Lynn Health Science Institute - Oklahoma City, Oklahoma, United States
- Coastal Pediatric Research - Charleston, South Carolina, United States
- Tribe Clinical Research LLC - Greenville, South Carolina, United States
- Avera McKennan Hospital & University Health Center - Sioux Falls, South Dakota, United States
- Avera Research Institute - Sioux Falls, South Dakota, United States
- Avera Medical Group Pediatrics - Dawley Farm - Sioux Falls, South Dakota, United States
- Monroe Carell Jr Children's Hospital at Vanderbilt - Nashville, Tennessee, United States
- Alina Clinical Trials, LLC. - Dallas, Texas, United States
- North Texas Center for Clinical Research - Frisco, Texas, United States
- DM Clinical Research - Cy Fair - Houston, Texas, United States
- SCLA Management - Drop Box - Houston, Texas, United States
- SCLA Management Office - Houston, Texas, United States
- NeuroCare Plus - Houston, Texas, United States
- Red Star Research, LLC - Lake Jackson, Texas, United States
- DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials - McAllen, Texas, United States
- DCT-Stone Oak, LLC dba Discovery Clinical Trials - San Antonio, Texas, United States
- Texas Institute for Neurological Disorders - Sherman, Texas, United States
- DM Clinical Research (Administrative Office Only) - Tomball, Texas, United States
- Victoria Clinical Research Group - Victoria, Texas, United States
- Meridian Clinical Research, LLC - Portsmouth, Virginia, United States
- ASST Spedali Civili di Brescia - Brescia, Italy
- Centre Hospitalier Intercommunal de Creteil - Créteil, France
- Instituto de Investigaciones del Sueno - Madrid, Spain
- Centre Hospitalier Universitaire de Montpellier - Montpellier, France
Showing 60 of 93 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →