Recruiting
Phase 3

Migraine

Sponsor:

Pfizer

Code:

NCT04649242

Conditions

Pediatric Migraine

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Rimegepant/BHV3000

Matching placebo

Study Details

Brief 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.

Conditions

Pediatric Migraine

Study ID

NCT04649242

Start date

Jan 15, 2021

Status verified date

Aug, 2026

Completion date

Jan 9, 2029

Anticipated

Primary completion date

Jan 9, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2100 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BHV3000 (active drug)

BHV3000 (rimegepant) 75 mg or 50 mg ODT

placebo comparator: Placebo

Matching 75 mg or 50 mg ODT placebo

Interventions

Rimegepant/BHV3000

BHV3000 (rimegepant) 75 mg or 50 mg ODT

Matching placebo

Matching 75 mg or 50 mg ODT placebo

Primary outcome measure

  • To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain. [ Time Frame: 2 hours post-dose ]

Central Contacts and Locations

Central contacts

Pfizer Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Perseverance Research Center, LLC

Recruiting

Scottsdale, Arizona, United States, 85253

Advanced Research Center, Inc.

Recruiting

Anaheim, California, United States, 92805

Adult & Child Neurology Medical Associates

Recruiting

Costa Mesa, California, United States, 92627

Memorial Health Services

Recruiting

Fountain Valley, California, United States, 92708

Neuro-Pain Research Center

Recruiting

Fresno, California, United States, 93710

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

Recruiting

La Jolla, California, United States, 92037

Adult & Child Neurology Medical Associates

Recruiting

Long Beach, California, United States, 90806

Miller Children's & Women's Hospital Long Beach

Recruiting

Long Beach, California, United States, 90806

The Neurology Group

Recruiting

Pomona, California, United States, 91767

Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)

Recruiting

San Bernardino, California, United States, 92408

Sunwise Clinical Research

Recruiting

Walnut Creek, California, United States, 94596

Children's Hospital Colorado- lnvestigational Drug Services

Recruiting

Aurora, Colorado, United States, 80045

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

CT Clinical Research

Recruiting

Cromwell, Connecticut, United States, 06416

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

Recruiting

Stamford, Connecticut, United States, 06905

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

South Florida Research Phase I-IV, Inc

Recruiting

Miami, Florida, United States, 33166

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Clinical Associates of Orlando, LLC

Recruiting

Orlando, Florida, United States, 32819

Pivotal Clinical Research & Associates, LLC

Recruiting

Brunswick, Georgia, United States, 31520

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Chicago Headache Center & Research Institute

Recruiting

Chicago, Illinois, United States, 60657

AMR-Baber Research Inc

Recruiting

Naperville, Illinois, United States, 60563

Options Research Group, LLC

Recruiting

Westfield, Indiana, United States, 46074

Velocity Clinical Research, Sioux City

Recruiting

Sioux City, Iowa, United States, 51106

Integrated Clinical Trial Services

Recruiting

West Des Moines, Iowa, United States, 50265

Clinical Associates Midwest, LLC

Recruiting

Kansas City, Kansas, United States, 66214

Michigan Head Pain & Neurological Institute

Recruiting

Ann Arbor, Michigan, United States, 48104

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Corewell Health, Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Beaumont Hospital Royal Oak Campus

Recruiting

Royal Oak, Michigan, United States, 48073

Brackenridge Outpatient Research Pharmacy

Recruiting

Rochester, Minnesota, United States, 55905

Clinical Research Trials Unit

Recruiting

Rochester, Minnesota, United States, 55905

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Precise Research Centers

Recruiting

Flowood, Mississippi, United States, 39232

Boeson Research

Recruiting

Great Falls, Montana, United States, 59405

Blue Moose Pediatrics

Recruiting

Missoula, Montana, United States, 59804

Boeson Research Laboratory

Recruiting

Missoula, Montana, United States, 59804

Boeson Research

Recruiting

Missoula, Montana, United States, 59804

Children's Hospital & Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

HMH Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

HOPE Tower at Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Dent Neurosciences Research Center

Recruiting

Amherst, New York, United States, 14226

True North Neurology

Recruiting

Commack, New York, United States, 11725

Northwell Health/ Division of Pediatric Neurology

Recruiting

Lake Success, New York, United States, 11042

New York Neurology Associates

Recruiting

New York, New York, United States, 10003

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

OnSite Clinical Solutions, LLC

Recruiting

Charlotte, North Carolina, United States, 28277

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Providence Neuroscience Institute - Research Coordinator's Office

Recruiting

Portland, Oregon, United States, 97225

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Clario

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Velocity Clinical Research-Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Dell Children's Medical Center

Recruiting

Austin, Texas, United States, 78723

Houston Clinical Trials, LLC

Recruiting

Bellaire, Texas, United States, 77401

FutureSearch Trials of Dallas, LLC

Recruiting

Dallas, Texas, United States, 75251

ANESC Research

Recruiting

El Paso, Texas, United States, 79912

UTHealth Houston

Recruiting

Houston, Texas, United States, 77030

Pain and Headache Centers of Texas

Recruiting

Houston, Texas, United States, 77054

SCLA Management

Recruiting

Houston, Texas, United States, 77077

NeuroCare Plus

Recruiting

Houston, Texas, United States, 77094

JBR Clinical Research

Recruiting

Salt Lake City, Utah, United States, 84107

Wasatch Clinical Research , LLC(Administrative Location)

Recruiting

Salt Lake City, Utah, United States, 84107

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

Recruiting

Charlottesville, Virginia, United States, 22902

Pediatric Research of Charlottesville, LLC (Regulatory Only)

Recruiting

Charlottesville, Virginia, United States, 22902

Pediatric Research of Charlottesville, LLC

Recruiting

Charlottesville, Virginia, United States, 22902

Children's Hospital of the King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Children's Specialty Group, PLLC

Recruiting

Norfolk, Virginia, United States, 23507

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

Recruiting

Norfolk, Virginia, United States, 23510

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Seattle Children's Hospital Investigational Drug Services

Recruiting

Seattle, Washington, United States, 98105

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Clinical Investigation Specialists, Inc

Recruiting

Kenosha, Wisconsin, United States, 53144

University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Kelowna Health & Memory Centre

Recruiting

Kelowna BC, British Columbia, Canada, V1Y 5A8

More Information

Sponsor

Pfizer

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Migraine
  • Acute treatment
  • Phonophobia
  • Photophobia
  • Nausea
  • Pediatric
  • Children
  • Adolescent
  • Pediatric Migraine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-14.