Clinical Trials in the USA / NCT04743141
Recruiting
Phase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
NCT04743141 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Acute Treatment of Migraine
Investigational drug(s) / intervention(s)
Rimegepant (PF-07899801): Rimegepant 75 mg, 50 mg or 35 mg ODT
Study summary
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Eligibility
Inclusion Criteria:
1. History of migraine (with or without aura) for ≥ 6 months before Screening.
2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
3. 1 or more migraine days requiring treatment during the Observation Phase.
4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
5. Ability to distinguish between migraine and other types of headaches.
6. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg.
7. Adequate venous access for blood sampling.
8. Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
Exclusion Criteria:
1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome.
3. 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).
4. History of suicidal behavior or at risk of self-harm/harm to others.
5. History of major psychiatric disorder.
6. Current diagnosis or history of substance abuse
7. Reported current use of or tested positive at Screening for drugs of abuse.
Primary outcome measure(s)
- The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities — 58 weeks
To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to \< 18 years of age).
Trial sites (124)
| Facility | City | Region | Status |
|---|---|---|---|
| Perseverance Research Center, LLC | Scottsdale | Arizona | Recruiting |
| Physicians Research Group | Tempe | Arizona | Active Not Recruiting |
| Advanced Research Center, Inc. | Anaheim | California | Recruiting |
| ProScience Research Group | Culver City | California | Active Not Recruiting |
| Neuro-Pain Research Center | Fresno | California | Recruiting |
| Altman Clinical and Translational Research Institute, University of California San Diego | La Jolla | California | Recruiting |
| Adult & Child Neurology Medical Associates | Long Beach | California | Recruiting |
| Memorialcare Miller Children's & Women's Hospital Long Beach | Long Beach | California | Recruiting |
| Velocity Clinical Research - North Hollywood | North Hollywood | California | Active Not Recruiting |
| The Neurology Group | Pomona | California | Recruiting |
| UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy | Sacramento | California | Active Not Recruiting |
| University of California, Davis Clinical and Translational Science Center Clinical Research Center | Sacramento | California | Active Not Recruiting |
| University of California, Davis Midtown Clinic | Sacramento | California | Active Not Recruiting |
| Velocity Clinical Research- Banning | San Bernardino | California | Active Not Recruiting |
| Pacific Clinical Research Management Group LLC | Upland | California | Active Not Recruiting |
| Sunwise Clinical Research | Walnut Creek | California | Recruiting |
| Children's Hospital Colorado- Investigational Drug Services | Aurora | Colorado | Recruiting |
| Children's Hospital Colorado | Aurora | Colorado | Recruiting |
| Colorado Springs Neurological Associates, PC | Colorado Springs | Colorado | Active Not Recruiting |
| Colorado Springs Neurological Associates, PC | Colorado Springs | Colorado | Active Not Recruiting |
| Boeson Research GJT | Grand Junction | Colorado | Terminated |
| Dinosaur Pediatrics | Grand Junction | Colorado | Terminated |
| Boeson Research GJT | Grand Junction | Colorado | Terminated |
| CT Clinical Research | Cromwell | Connecticut | Recruiting |
| Ki Health Partners, LLc, dba New England Institute for Clinical Research | Stamford | Connecticut | Recruiting |
| Children's National Medical Center | Washington D.C. | District of Columbia | Recruiting |
| AppleMed Research Group, LLC | Miami | Florida | Active Not Recruiting |
| Medical Research Center of Miami II, Inc | Miami | Florida | Active Not Recruiting |
| South Florida Research Phase I-IV, Inc | Miami | Florida | Recruiting |
| Physicians Group Services, PA d/b/a Coastal Health Research | Orange Park | Florida | Active Not Recruiting |
| Clinical Associates of Orlando, LLC | Orlando | Florida | Recruiting |
| ForCare Clinical Research | Tampa | Florida | Active Not Recruiting |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | Active Not Recruiting |
| Rare Disease Research LLC | Atlanta | Georgia | Active Not Recruiting |
| Pivotal Clinical Research & Associates, LLC | Brunswick | Georgia | Active Not Recruiting |
| CenExel iResearch, LLC | Decatur | Georgia | Recruiting |
| Chicago Headache Center & Research Institute | Chicago | Illinois | Recruiting |
| AMR-Baber Research Inc | Naperville | Illinois | Recruiting |
| Options Research Group, LLC | Westfield | Indiana | Recruiting |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | Recruiting |
+ 84 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04743141 on ClinicalTrials.gov ↗ ← All trials in the USA