RECRUITINGPhase 3INTERVENTIONAL
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
2. 6 or more migraine days during the Observation Period
3. 14 or less headache days during the Observation Period
4. 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
5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
7. 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.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Who Should NOT Join This Trial:
1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
5. 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
2. 6 or more migraine days during the Observation Period
3. 14 or less headache days during the Observation Period
4. 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
5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
7. 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.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Exclusion Criteria:
1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
5. 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.
6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
7. History of major psychiatric disorder.
8. The subject has a current diagnosis or history of substance abuse
9. 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.
Treatments Being Tested
DRUG
Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
DRUG
Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Locations (20)
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
Meridian Clinical Research, LLC
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
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