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 Genders
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

Perseverance Research Center, LLC
Scottsdale, Arizona 85253

Perseverance Research Center, LLC
Scottsdale, Arizona 85254

Advanced Research Center, Inc.
Anaheim, California 92805

ProScience Research Group
Culver City, California 90230

Neuro-Pain Medical Center
Fresno, California 93710

University of California San Diego, Altman Clinical and Translational Research Institute Clinic
La Jolla, California 92037

Sunwise Clinical Research
Lafayette, California 94549

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

Velocity Clinical Research - North Hollywood
North Hollywood, California 91606

The Neurology Group
Pomona, California 91767

UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
Sacramento, California 95817

University of California, Davis Clinical and Translational Science Center Clinical Research Center
Sacramento, California 95817

University of California, Davis Midtown Clinic
Sacramento, California 95817

Velocity Clinical Research- Banning
San Bernardino, California 92408

Pacific Clinical Research Management Group LLC
Upland, California 91786

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

Children's Hospital Colorado
Aurora, Colorado 80045

Colorado Springs Neurological Associates
Colorado Springs, Colorado 80907

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 Springs, Florida 33166

AppleMed Research Group, LLC
Miami, Florida 33126

Brainstorm Research
Miami, Florida 33176

Coastal Clinical Research Specialists
Orange Park, Florida 32073

ForCare Clinical Research
Tampa, Florida 33613

Childrens Healthcare of Atlanta
Atlanta, Georgia 30329

Pivotal Clinical Research & Associates, LLC
Brunswick, Georgia 31520

CenExel iResearch, LLC
Decatur, Georgia 30030

Chicago Headache Center & Research Institute
Chicago, Illinois 60657

Physicians Research Group (Administrative Office Location)
Noblesville, Indiana 46060

Options Research Group, LLC
Westfield, Indiana 46074

Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan 48104

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

Beaumont Hospital, Royal Oak Campus
Royal Oak, Michigan 48073

Sharlin Health Neuroscience Research Center
Ozark, Missouri 65721

Boeson Research
Great Falls, Montana 59405

Boeson Research,LLC
Kalispell, Montana 59901

Boeson Research
Missoula, Montana 59804

Dent Neurosciences Research Center
Amherst, New York 14226

New York Neurology Associates
New York, New York 10003

Columbia University Medical Center Research Pharmacy
New York, New York 10032

Columbia University Pediatric Neuromuscular Center
New York, New York 10032

Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
New York, New York 10032

The Neurological Institute of New York
New York, New York 10032

Headache Wellness Center, PC
Greensboro, North Carolina 27405

Cincinnati Children's Hospital
Cincinnati, Ohio 45229

Drug Delivery-Cincinnati Children's IDS Denise Lagory
Cincinnati, Ohio 45229

Velocity Clinical Research - Cincinnati
Cincinnati, Ohio 45242

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Velocity Clinical Research, Grants Pass
Grants Pass, Oregon 97527

Providence Brain & Spine Institute-research coordinator's office
Portland, Oregon 97225

Providence Health & Services Investigational Drug Services Westside
Portland, Oregon 97225

Providence St. Vincent Medical Center
Portland, Oregon 97225

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104

Velocity Clinical Research-Providence
East Greenwich, Rhode Island 02818

Tribe Clinical Research LLC
Greenville, South Carolina 29607

Velocity Clinical Research- Greenville
Greenville, South Carolina 29615

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

Child Neurology Consultants of Austin - Central Austin
Austin, Texas 78757

Houston Clinical Trials, LLC
Bellaire, Texas 77401

Cedar Health Research
Dallas, Texas 75251

ANRC Research
El Paso, Texas 79912

Pain and Headache Centers of Texas
Houston, Texas 77054

NeuroCare Plus
Houston, Texas 77094

AIM Trials, LLC
Plano, Texas 75093

JBR Clinical Research
Salt Lake City, Utah 84107

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

Children's Hospital of The King's Daughters
Norfolk, Virginia 23507

Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology
Norfolk, Virginia 23510

Northwest Clinical Research Center
Bellevue, Washington 98007

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

Seattle Children's Hospital
Seattle, Washington 98105

University Hospital
Madison, Wisconsin 53792

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

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