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RECRUITING

NCT04649242

PHASE3

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

Official title: Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

2100

Start Date

2021-01-15

Completion Date

2029-01-09

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Pediatric Migraine

Interventions

DRUG

Rimegepant/BHV3000

BHV3000 (rimegepant) 75 mg or 50 mg ODT

DRUG

Matching placebo

Matching 75 mg or 50 mg ODT placebo

Inclusion Criteria: 1. History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s). 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours. 3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study. 1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases. 2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited. 3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit. 4. Verbally distinguish between migraine and other types of headaches. 5. Participants must have a weight \> 40 kg at the Screening Visit. 6. Adequate venous access for blood sampling. 7. Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study). Exclusion Criteria: 1. History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study. 3. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania. 4. History of suicidal behavior or major psychiatric disorder. 5. Current diagnosis or history of substance abuse; positive drug test at Screening. 6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning. 7. Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit. 8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding). 9. Current diagnosis of viral hepatitis or a history of liver disease. 10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Locations (246)

Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama

Birmingham, Alabama, United States

Perseverance Research Center, LLC

Scottsdale, Arizona, United States

Physicians Research Group

Tempe, Arizona, United States

Advanced Research Center, Inc.

Anaheim, California, United States

Adult & Child Neurology Medical Associates

Costa Mesa, California, United States

ProScience Research Group

Culver City, California, United States

Memorial Health Services

Fountain Valley, California, United States

Neuro-Pain Research Center

Fresno, California, United States

Altman Clinical and Translational Research Institute, University of California San Diego

La Jolla, California, United States

Adult & Child Neurology Medical Associates

Long Beach, California, United States

Miller Children's & Women's Hospital Long Beach

Long Beach, California, United States

National Research Institute

Los Angeles, California, United States

Velocity Clinical Research - North Hollywood

North Hollywood, California, United States

Children's Hospital of Orange County - Inpatient Pharmacy

Orange, California, United States

Children's Hospital of Orange County - Neuroscience Center

Orange, California, United States

Children's Hospital of Orange County

Orange, California, United States

The Neurology Group

Pomona, California, United States

University of California, Davis Midtown Clinic

Sacramento, 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 (CCRC)

Sacramento, California, United States

Velocity Clinical Research, San Bernardino

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- lnvestigational 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

CT Clinical Research

Cromwell, Connecticut, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

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

Stamford, Connecticut, United States

Nemours Children's Hospital, Delaware

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Topaz Clinical Research, Inc.

Apopka, Florida, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

DeLand Clinical Research Unit

DeLand, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Multi-Specialty Research Associates, Inc.

Lake City, Florida, United States

Watson Clinic Center for Research, Inc.

Lakeland, Florida, United States

Watson Clinic LLP

Lakeland, Florida, United States

AppleMed Research Group, LLC

Miami, Florida, United States

Medical Research Center of Miami II, Inc

Miami, Florida, United States

South Florida Research Phase I-IV, Inc

Miami, Florida, United States

Brainstorm Research

Miami, Florida, United States

Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office

Naples, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Coastal Clinical Research Specialists

Orange Park, Florida, United States

Clinical Associates of Orlando, LLC

Orlando, Florida, United States

Bioresearch Institute

Pembroke Pines, Florida, United States

Forcare Clinical Research

Tampa, Florida, United States

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, United States

Children's Healthcare of Atlanta, Inc.

Atlanta, Georgia, United States

Childrens Healthcare of Atlanta

Atlanta, Georgia, United States

Rare Disease Research, LLC

Atlanta, Georgia, United States

Pivotal Clinical Research & Associates, LLC

Brunswick, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

Chicago Headache Center & Research Institute

Chicago, Illinois, United States

AMR-Baber Research Inc

Naperville, Illinois, United States

Options Research Group, LLC

Westfield, Indiana, United States

Velocity Clinical Research, Sioux City

Sioux City, Iowa, United States

Integrated Clinical Trial Services

West Des Moines, Iowa, United States

Clinical Associates Midwest, LLC

Kansas City, Kansas, United States

College Park Family Care Center Physicians Group- Neurology Research Dept.

Overland Park, Kansas, United States

Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"

Lexington, Kentucky, United States

UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"

Lexington, Kentucky, United States

University of Kentucky Hospital

Lexington, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Neurology and Headache Center, Inc.

Shreveport, Louisiana, United States

Boston Clinical Trials

Boston, Massachusetts, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, United States

Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group

Grand Rapids, Michigan, United States

Corewell Health, Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Wellnow Urgent Care and Research

Kalamazoo, Michigan, United States

Beaumont Hospital Royal Oak Campus

Royal Oak, Michigan, United States

Brackenridge Outpatient Research Pharmacy

Rochester, Minnesota, United States

Clinical Research Trials Unit

Rochester, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Precise Research Centers

Flowood, Mississippi, United States

Sharlin Health Neuroscience Research Center

Ozark, Missouri, United States

Clinvest Research, LLC

Springfield, Missouri, United States

Boeson Research

Great Falls, Montana, United States

Boeson Research

Kalispell, Montana, United States

Heart & Hands Midwifery

Kalispell, Montana, United States

Blue Moose Pediatrics

Missoula, Montana, United States

Boeson Research Laboratory

Missoula, Montana, United States

Boeson Research

Missoula, Montana, United States

Alivation Research, LLC.

Lincoln, Nebraska, United States

Children's Hospital & Medical Center

Omaha, Nebraska, United States

HMH Jersey Shore University Medical Center

Neptune City, New Jersey, United States

HOPE Tower at Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Dent Neurosciences Research Center

Amherst, New York, United States

True North Neurology

Commack, New York, United States

Northwell Health IRB

Great Neck, New York, United States

Northwell Health Division of Pediatric Neurology Outpatient EEG Lab

Lake Success, New York, United States

Northwell Health/ Division of Pediatric Neurology

Lake Success, New York, United States

NYU Langone Hospital-Long Island, Clinical Research Center

Mineola, New York, United States

NYU Langone Hospital-Long Island, Pediatric Neurology

Mineola, New York, United States

New York Neurology Associates

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Mount Sinai Hospital - Pharmacy Department

New York, New York, United States

And 146 more locations on ClinicalTrials.gov

Clinical Research Directory

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (246)