RECRUITINGPhase 3INTERVENTIONAL
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
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).
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Rimegepant (PF-07899801)
Rimegepant 75 mg, 50 mg or 35 mg ODT
Locations (20)
Perseverance Research Center, LLC
Scottsdale, Arizona, United States
Physicians Research Group
Tempe, Arizona, United States
Advanced Research Center, Inc.
Anaheim, California, United States
ProScience Research Group
Culver City, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Regents of the University of California (UC San Diego)
La Jolla, California, United States
Adult & Child Neurology Medical Associates
Long Beach, California, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, United States
The Neurology Group
Pomona, California, United States
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
Sacramento, California, United States
University of California, Davis Clinical and Translational Science Center Clinical Research Center
Sacramento, California, United States
University of California, Davis Midtown Clinic
Sacramento, California, United States
Velocity Clinical Research- Banning
San Bernardino, California, United States
Pacific Clinical Research Management Group LLC
Upland, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
Children's Hospital Colorado- Investigational Drug Services
Aurora, Colorado, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, United States
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, United States