Randomized Study in Children and Adolescents With Migraine: Acute Treatment

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

  • Pediatric Migraine

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 5313457, Arizona 5551752 85253

Advanced Research Center, Inc.
Anaheim 5323810, California 5332921 92805

Adult & Child Neurology Medical Associates
Costa Mesa 5339840, California 5332921 92627

ProScience Research Group
Culver City 5341114, California 5332921 90230

Memorial Health Services
Fountain Valley 5350207, California 5332921 92708

Neuro-Pain Medical Center
Fresno 5350937, California 5332921 93710

Altman Clinical and Translational Research Institute-IDS
La Jolla 5363943, California 5332921 92037

University of California, San Diego Altman Clinical Translational Research Institute
La Jolla 5363943, California 5332921 92037

Adult & Child Neurology Medical Associates
Long Beach 5367929, California 5332921 90806

Miller Children's & Women's Hospital Long Beach
Long Beach 5367929, California 5332921 90806

The Neurology Group
Pomona 5384170, California 5332921 91767

Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)
San Bernardino 5391710, California 5332921 92408

Pacific Clinical Research Management Group LLC
Upland 5404915, California 5332921 91786

Sunwise Clinical Research
Walnut Creek 5406990, California 5332921 94596

Children's Hospital Colorado- lnvestigational Drug Services
Aurora 5412347, Colorado 5417618 80045

Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045

Colorado Springs Neurological Associates, PC
Colorado Springs 5417598, Colorado 5417618 80907

Colorado Springs Neurological Associates, PC
Colorado Springs 5417598, Colorado 5417618 80919

CT Clinical Research
Cromwell 4832121, Connecticut 4831725 06416

Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford 4843564, Connecticut 4831725 06905

Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20010

AppleMed Research Group, LLC
Miami 4164138, Florida 4155751 33126

South Florida Research Phase I-IV, Inc
Miami Springs 4164223, Florida 4155751 33166

Aqualane Clinical Research
Naples 4165565, Florida 4155751 34105

Coastal Clinical Research Specialists
Orange Park 4167102, Florida 4155751 32073

Clinical Associates of Orlando, LLC
Orlando 4167147, Florida 4155751 32819

Forcare Clinical Research
Tampa 4174757, Florida 4155751 33613

Children's Healthcare of Atlanta, Inc.
Atlanta 4180439, Georgia 4197000 30329

Childrens Healthcare of Atlanta
Atlanta 4180439, Georgia 4197000 30329

Pivotal Clinical Research & Associates, LLC
Brunswick 4184845, Georgia 4197000 31520

CenExel iResearch, LLC
Decatur 4191124, Georgia 4197000 30030

Chicago Headache Center & Research Institute
Chicago 4887398, Illinois 4896861 60657

AMR-Baber Research Inc
Naperville 4903279, Illinois 4896861 60563

Options Research Group, LLC
Westfield 4928118, Indiana 4921868 46074

Meridian Clinical Research, LLC
Sioux City 4876523, Iowa 4862182 51106

Integrated Clinical Trial Services
West Des Moines 4881346, Iowa 4862182 50265

Clinical Associates Midwest, LLC
Kansas City 4273837, Kansas 4273857 66214

Michigan Head Pain & Neurological Institute
Ann Arbor 4984247, Michigan 5001836 48104

Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
Grand Rapids 4994358, Michigan 5001836 49503

Corewell Health, Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836 49503

Beaumont Hospital Royal Oak Campus
Royal Oak 5007804, Michigan 5001836 48073

Precise Research Centers
Flowood 4426822, Mississippi 4436296 39232

Sharlin Health Neuroscience Research Center
Ozark 4402245, Missouri 4398678 65721

Boeson Research
Great Falls 5655240, Montana 5667009 59405

Blue Moose Pediatrics
Missoula 5666639, Montana 5667009 59804

Boeson Research Laboratory
Missoula 5666639, Montana 5667009 59804

Boeson Research
Missoula 5666639, Montana 5667009 59804

Children's Hospital & Medical Center
Omaha 5074472, Nebraska 5073708 68114

Dent Neurosciences Research Center
Amherst 5107129, New York 5128638 14226

True North Neurology
Commack 5113412, New York 5128638 11725

Northwell Health/ Division of Pediatric Neurology
Lake Success 5123853, New York 5128638 11042

New York Neurology Associates
New York 5128581, New York 5128638 10003

Weill Cornell Medicine
New York 5128581, New York 5128638 10021

OnSite Clinical Solutions, LLC
Charlotte 4460243, North Carolina 4482348 28277

Velocity Clinical Research, Inc.
Durham 4464368, North Carolina 4482348 27701

Headache Wellness Center, PC
Greensboro 4469146, North Carolina 4482348 27405

Akron Children's Hospital
Akron 5145476, Ohio 5165418 44308

Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229

Velocity Clinical Research
Cincinnati 4508722, Ohio 5165418 45242

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

Providence Brain & Spine Institute-research coordinator's office
Portland 5746545, Oregon 5744337 97225

Providence Health & Services Investigational Drug Services Westside
Portland 5746545, Oregon 5744337 97225

Providence Pediatric Neurology
Portland 5746545, Oregon 5744337 97225

Clario
Philadelphia 4560349, Pennsylvania 6254927 19103

Velocity Clinical Research-Providence
East Greenwich 5221875, Rhode Island 5224323 02818

Le Bonheur Children's Hospital - Outpatient Building
Memphis 4641239, Tennessee 4662168 38103

Le Bonheur Children's Hospital
Memphis 4641239, Tennessee 4662168 38103

Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
Memphis 4641239, Tennessee 4662168 38103

Dell Children's Medical Center
Austin 4671654, Texas 4736286 78723

Child Neurology Consultants of Austin - South Austin
Austin 4671654, Texas 4736286 78749

Child Neurology Consultants of Austin - Central Austin
Austin 4671654, Texas 4736286 78757

Houston Clinical Trials, LLC
Bellaire 4673353, Texas 4736286 77401

Infinite Research Group, LLC
Dallas 4684888, Texas 4736286 75201

Children's Medical Center, Dallas
Dallas 4684888, Texas 4736286 75235

Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
Dallas 4684888, Texas 4736286 75235

Cedar Health Research
Dallas 4684888, Texas 4736286 75251

FutureSearch Trials of Dallas, LLC
Dallas 4684888, Texas 4736286 75251

The University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

ANESC Research
El Paso 5520993, Texas 4736286 79912

UTHealth Houston
Houston 4699066, Texas 4736286 77030

Pain and Headache Centers of Texas
Houston 4699066, Texas 4736286 77054

SCLA Management
Houston 4699066, Texas 4736286 77077

NeuroCare Plus
Houston 4699066, Texas 4736286 77094

AIM Trials, LLC
Plano 4719457, Texas 4736286 75093

JBR Clinical Research
Salt Lake City 5780993, Utah 5549030 84107

Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City 5780993, Utah 5549030 84107

Pediatric Research of Charlottesville, LLC (Regulatory Only)
Charlottesville 4752031, Virginia 6254928 22902

Pediatric Research of Charlottesville, LLC
Charlottesville 4752031, Virginia 6254928 22902

Children's Hospital of the King's Daughters
Norfolk 4776222, Virginia 6254928 23507

Children's Specialty Group, PLLC
Norfolk 4776222, Virginia 6254928 23507

Children's Specialty Group, PLLC, Division of Childhood & Adolescent Neurology
Norfolk 4776222, Virginia 6254928 23510

Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007

Seattle Children's Hospital Investigational Drug Services
Seattle 5809844, Washington 5815135 98105

Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105

Clinical Investigation Specialists, Inc
Kenosha 5258393, Wisconsin 5279468 53144

University Hospital
Madison 5261457, Wisconsin 5279468 53792

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

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