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Purpose

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.

Condition

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 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
BHV3000 (active drug) 		BHV3000 (rimegepant) 75 mg or 50 mg ODT
  • Drug: Rimegepant/BHV3000
    BHV3000 (rimegepant) 75 mg or 50 mg ODT
Placebo Comparator
Placebo 		Matching 75 mg or 50 mg ODT placebo
  • Drug: Matching placebo
    Matching 75 mg or 50 mg ODT placebo

Recruiting Locations

Perseverance Research Center, LLC
Scottsdale, Arizona 85253

Advanced Research Center, Inc.
Anaheim, California 92805

Adult & Child Neurology Medical Associates
Costa Mesa, California 92627

ProScience Research Group
Culver City, California 90230

Memorial Health Services
Fountain Valley, California 92708

Neuro-Pain Research Center
Fresno, California 93710

Regents of the University of California (UC San Diego)
La Jolla, California 92093

Adult & Child Neurology Medical Associates
Long Beach, California 90806

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

The Neurology Group
Pomona, California 91767

Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)
San Bernardino, California 92408

Sunwise Clinical Research
Walnut Creek, California 94596

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

Children's Hospital Colorado
Aurora, Colorado 80045

CT Clinical Research
Cromwell, Connecticut 06416

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

Children's National Medical Center
Washington D.C., District of Columbia 20010

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

Aqualane Clinical Research
Naples, Florida 34105

Clinical Associates of Orlando, LLC
Orlando, Florida 32819

Children's Healthcare of Atlanta, Inc.
Atlanta, Georgia 30329

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

AMR-Baber Research Inc
Naperville, Illinois 60563

Options Research Group, LLC
Westfield, Indiana 46074

Velocity Clinical Research, Sioux City
Sioux City, Iowa 51106

Integrated Clinical Trial Services
West Des Moines, Iowa 50265

Clinical Associates Midwest, LLC
Kansas City, Kansas 66214

Michigan Head Pain & 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

Corewell Health, Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503

Beaumont Hospital Royal Oak Campus
Royal Oak, Michigan 48073

Brackenridge Outpatient Research Pharmacy
Rochester, Minnesota 55905

Clinical Research Trials Unit
Rochester, Minnesota 55905

Mayo Clinic
Rochester, Minnesota 55905

Precise Research Centers
Flowood, Mississippi 39232

Boeson Research
Great Falls, Montana 59405

Blue Moose Pediatrics
Missoula, Montana 59804

Boeson Research Laboratory
Missoula, Montana 59804

Boeson Research
Missoula, Montana 59804

Children's Hospital & Medical Center
Omaha, Nebraska 68114

HMH Jersey Shore University Medical Center
Neptune City, New Jersey 07753

HOPE Tower at Jersey Shore University Medical Center
Neptune City, New Jersey 07753

Dent Neurosciences Research Center
Amherst, New York 14226

True North Neurology
Commack, New York 11725

Northwell Health/ Division of Pediatric Neurology
Lake Success, New York 11042

New York Neurology Associates
New York, New York 10003

Weill Cornell Medicine
New York, New York 10021

OnSite Clinical Solutions, LLC
Charlotte, North Carolina 28277

Velocity Clinical Research, Inc.
Durham, North Carolina 27701

Headache Wellness Center, PC
Greensboro, North Carolina 27405

Akron Children's Hospital
Akron, Ohio 44308

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

Velocity Clinical Research
Cincinnati, Ohio 45242

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Providence Neuroscience Institute - Research Coordinator's Office
Portland, Oregon 97225

Providence Pediatric Neurology
Portland, Oregon 97225

Providence St. Vincent Medical Center
Portland, Oregon 97225

Clario
Philadelphia, Pennsylvania 19103

Velocity Clinical Research-Providence
East Greenwich, Rhode Island 02818

Le Bonheur Children's Hospital - Outpatient Building
Memphis, Tennessee 38103

Le Bonheur Children's Hospital
Memphis, Tennessee 38103

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

Le Bonheur Outpatient Pharmacy
Memphis, Tennessee 38105

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

Children's Medical Center, Dallas
Dallas, Texas 75235

Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
Dallas, Texas 75235

FutureSearch Trials of Dallas, LLC
Dallas, Texas 75251

The University of Texas Southwestern Medical Center
Dallas, Texas 75390

ANESC Research
El Paso, Texas 79912

UTHealth Houston
Houston, Texas 77030

Pain and Headache Centers of Texas
Houston, Texas 77054

SCLA Management
Houston, Texas 77077

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

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
Charlottesville, Virginia 22902

Pediatric Research of Charlottesville, LLC (Regulatory Only)
Charlottesville, Virginia 22902

Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia 22902

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

Children's Specialty Group, PLLC
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

Clinical Investigation Specialists, Inc
Kenosha, Wisconsin 53144

University Hospital
Madison, Wisconsin 53792

More Details

NCT ID
NCT04649242
Status
Recruiting
Sponsor
Pfizer

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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