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

Purpose

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.

Condition

  • Migraine

Eligibility

Eligible Ages
Between 6 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Rimegepant / BHV3000 		Rimegepant 75mg or 50mg (2 X 25mg) ODT
  • Drug: Rimegepant
    Rimegepant 75mg or 50mg (2 X 25mg) ODT
    Other names:
    • BHV3000
Placebo Comparator
Matching Placebo 		Matching placebo 75mg or 50mg (2 X 25mg) ODT
  • Drug: Placebo
    Matching placebo 75mg or 50mg (2 X 25mg) ODT
    Other names:
    • Matching Placebo

Recruiting Locations

Advanced Investigative Medicine, Inc.
Hawthorne, California 90250

Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia 20016

Direct Helpers Research Center
Hialeah, Florida 33012

D&H Tamarac Research Center LLC
Tamarac, Florida 33321

Santos Research Center, CORP
Tampa, Florida 33615

Augusta University
Augusta, Georgia 30912

Northwest Clinical Trials, Inc.
Boise, Idaho 83704

Nola Research Works, LLC
New Orleans, Louisiana 70125

Safe Haven Clinical Research
Clinton, Mississippi 39056

Roy Blunt NextGen Precision Health Building
Columbia, Missouri 65211

University of Missouri Health Care - Investigation Pharmacy
Columbia, Missouri 65212

University of Missouri-Clinical and Translational Sciences Unit
Columbia, Missouri 65212

University of Missouri
Columbia, Missouri 65212

Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803

Papillion Research Center/CCT Research
Papillion, Nebraska 68046

Montefiore Medical Center
The Bronx, New York 10461

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota 57105

Avera Research Institute
Sioux Falls, South Dakota 57108

Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota 57110

Alina Clinical Trials, LLC.
Dallas, Texas 75209

North Texas Center for Clinical Research
Frisco, Texas 75034

DM Clinical Research - Cy Fair
Houston, Texas 77065

SCLA Management - Drop Box
Houston, Texas 77077

SCLA Management Office
Houston, Texas 77077

NeuroCare Plus
Houston, Texas 77094

DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas 78503

DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas 78258

DM Clinical Research (Administrative Office Only)
Tomball, Texas 77375

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com