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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 Genders
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

Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama
Birmingham, Alabama 35244

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 Translational Research Institute
La Jolla, California 92037

Sunwise Clinical Research, LLC
Lafayette, California 94549

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

University of California, Davis Midtown Clinic
Sacramento, California 95816

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

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

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

Pacific Clinical Research Management Group LLC
Upland, California 91786

Children's Hospital Colorado- lnvestigational 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

Nemours Children's Hospital, Delaware
Wilmington, Delaware 19803

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

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

AppleMed Research Group, LLC
Miami, Florida 33126

Brainstorm Research
Miami, Florida 33176

Aqualane Clinical Research
Naples, Florida 34105

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

AMR-Baber Research Inc
Naperville, Illinois 60563

Options Research Group, LLC
Westfield, Indiana 46074

Meridian Clinical Research, LLC
Sioux City, Iowa 51106

Integrated Clinical Trial Services
West Des Moines, Iowa 50265

Clinical Associates Midwest, LLC
Kansas City, Kansas 66214

MedVadis Research Corporation
Waltham, Massachusetts 02451

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

Precise Research Centers
Flowood, Mississippi 39232

Sharlin Health Neuroscience Research Center
Ozark, Missouri 65721

Boeson Research
Great Falls, Montana 59405

Boeson Research LLC
Kalispell, Montana 59901

Blue Moose Pediatrics
Missoula, Montana 59804

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

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

NYU Langone Hospital-Long Island, Clinical Research Center
Mineola, New York 11501

NYU Langone Hospital-Long Island, Pediatric Neurology
Mineola, New York 11501

New York Neurology Associates
New York, New York 10003

Weil Cornell Medicine, New York-Presbyterian
New York, New York 10021

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

Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157

Akron Children's Hospital
Akron, Ohio 44308

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

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

Velocity Clinical Research
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

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

Future Search Trials of Dallas, LP
Dallas, Texas 75231

Children's Medical Center, Dallas
Dallas, Texas 75235

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

Cedar Health Research
Dallas, Texas 75251

ANESC Research
El Paso, Texas 79912

ANRC Research
El Paso, Texas 79912

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

The University of Vermont Medical Center
Burlington, Vermont 05401

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, 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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