Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Purpose

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).

Condition

  • Acute Treatment of Migraine

Eligibility

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active 		rimegepant 75 mg, 50 mg or 35 mg ODT
  • Drug: Rimegepant (PF-07899801)
    Rimegepant 75 mg, 50 mg or 35 mg ODT

Recruiting Locations

Advanced Research Center, Inc.
Anaheim, California 92805

Adult & Child Neurology Medical Associates
Long Beach, California 90806

Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California 90806

Velocity Clinical Research- Banning
San Bernardino, California 92408

Sunwise Clinical Research
Walnut Creek, California 94596

Children's Hospital Colorado- Investigational Drug Services
Aurora, Colorado 80045

CT Clinical Research
Cromwell, Connecticut 06416

Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut 06905

South Florida Research Phase I-IV, Inc
Miami, Florida 33166

Pivotal Clinical Research & Associates, LLC
Brunswick, Georgia 31520

Chicago Headache Center & Research Institute
Chicago, Illinois 60657

AMR-Baber Research Inc
Naperville, Illinois 60563

Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
Grand Rapids, Michigan 49503

Boeson Research
Missoula, Montana 59804

Children's Hospital & Medical Center
Omaha, Nebraska 68114

Dent Neurosciences Research Center
Amherst, New York 14226

True North Neurology
Commack, New York 11725

OnSite Clinical Solutions, LLC
Charlotte, North Carolina 28277

Cincinnati Children's Hospital
Cincinnati, Ohio 45229

Velocity Clinical Research - Cincinnati
Cincinnati, Ohio 45242

Providence Investigational Drug Service - Westside
Portland, Oregon 97225

Velocity Clinical Research-Providence
East Greenwich, Rhode Island 02818

Le Bonheur Children's Hospital
Memphis, Tennessee 38103

Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
Memphis, Tennessee 38103

Le Bonheur Childrens Hospital - Outpatient Building
Memphis, Tennessee 38103

Dell Children's Medical Center
Austin, Texas 78723

Child Neurology Consultants of Austin - South Austin
Austin, Texas 78749

Houston Clinical Trials, LLC
Bellaire, Texas 77401

Cedar Health Research
Dallas, Texas 75251

Pain and Headache Centers of Texas
Houston, Texas 77054

Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City, Utah 84107

Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia 22902

Northwest Clinical Research Center
Bellevue, Washington 98007

Seattle Children's Hospital Investigational Drug Services
Seattle, Washington 98105

Seattle Children's Hospital
Seattle, Washington 98105

More Details

NCT ID
NCT04743141
Status
Recruiting
Sponsor
Pfizer

Study Contact

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

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Vanderbilt University Medical Center