RECRUITING

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

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Conditions

Pediatric MigraineMigraineAcute treatmentPhonophobiaPhotophobiaNauseaPediatricChildrenAdolescent

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-01-15
Study Completion:2029-01-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04649242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 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.
  4. 1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
  5. 2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
  6. 3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
  7. 4. Verbally distinguish between migraine and other types of headaches.
  8. 5. Participants must have a weight \> 40 kg at the Screening Visit.
  9. 6. Adequate venous access for blood sampling.
  10. 7. Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).
  1. 1. History of cluster headache or hemiplegic migraine headache.
  2. 2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
  3. 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. 4. History of suicidal behavior or major psychiatric disorder.
  5. 5. Current diagnosis or history of substance abuse; positive drug test at Screening.
  6. 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. 7. Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
  8. 8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
  9. 9. Current diagnosis of viral hepatitis or a history of liver disease.
  10. 10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Contacts and Locations

Study Contact

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

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Accel Research Sites-Neurology and Neurodiagnostics of Alabama, LLC
Birmingham, Alabama, 35244
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Perseverance Research Center, LLC
Scottsdale, Arizona, 85254
United States
Physicians Research Group
Tempe, Arizona, 85284
United States
Advanced Research Center, Inc.
Anaheim, California, 92805
United States
Velocity Clinical Research, Banning
Banning, California, 92220
United States
ProScience Research Group
Culver City, California, 90230
United States
Neuro-Pain Medical Center
Fresno, California, 93710
United States
University of California, San Diego Altman Clinical Translational Research Institute
La Jolla, California, 92037
United States
Sunwise Clinical Research, LLC
Lafayette, California, 94549
United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
United States
Children's Hospital Los Angeles, Division of Neurology
Los Angeles, California, 90027
United States
Children's Hospital Los Angeles-Children's Hospital Los Angeles Dept of Pharmacy
Los Angeles, California, 90027
United States
National Research Institute
Los Angeles, California, 90057
United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, 91606
United States
The Neurology Group
Pomona, California, 91767
United States
University of California, Davis Midtown Clinic
Sacramento, California, 95816
United States
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
Sacramento, California, 95817
United States
University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
Sacramento, California, 95817
United States
University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
Sacramento, California, 95817
United States
Velocity Clinical Research, Banning
San Bernardino, California, 92408
United States
Pacific Clinical Research Management Group LLC
Upland, California, 91786
United States
Children's Hospital Colorado- lnvestigational Drug Services
Aurora, Colorado, 80045
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
United States
Boeson Research
Grand Junction, Colorado, 81501
United States
Dinosaur Junction Pediatrics
Grand Junction, Colorado, 81501
United States
Boeson Research - Grand Junction, CO
Grand Junction, Colorado, 81505
United States
CT Clinical Research
Cromwell, Connecticut, 06416
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905
United States
Nemours Children's Health
Wilmington, Delaware, 19803
United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Topaz Clinical Research, Inc.
Apopka, Florida, 32703
United States
First Choice Neurlogy Espinosa Neuroscience Institute
Boca Raton, Florida, 33486
United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157
United States
DeLand Clinical Research Unit
DeLand, Florida, 32720
United States
University Clinical Research - Deland, LLC dba Accel Research Sites
DeLand, Florida, 32720
United States
Sarkis Clinical Trials
Gainesville, Florida, 32607
United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055
United States
Watson Clinic Center for Research, Inc.
Lakeland, Florida, 33805
United States
Watson Clinic LLP
Lakeland, Florida, 33805
United States
South Florida Research Phase I-IV, Inc
Miami Springs, Florida, 33166
United States
AppleMed Research Group, LLC
Miami, Florida, 33126
United States
Medical Research Center of Miami II, Inc
Miami, Florida, 33134
United States
Nicklaus Children's Hospital, Research Institute
Miami, Florida, 33155
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Genoma Research Group, Inc.
Miami, Florida, 33165
United States
Brainstorm Research
Miami, Florida, 33176
United States
The Neurology Research Group
Miami, Florida, 33176
United States
Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
Naples, Florida, 34102
United States
Aqualane Clinical Research
Naples, Florida, 34105
United States
Collier Neurologic Specialists, LLC
Naples, Florida, 34105
United States
Coastal Clinical Research Specialists
Orange Park, Florida, 32073
United States
Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
Orlando, Florida, 32806
United States
Orlando Health Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
Bioresearch Institute
Pembroke Pines, Florida, 33026
United States
Forcare Clinical Research
Tampa, Florida, 33613
United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
United States
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta, Georgia, 30329
United States
Rare Disease Research, LLC
Atlanta, Georgia, 30329
United States
Pivotal Clinical Research & Associates, LLC
Brunswick, Georgia, 31520
United States
CenExel iResearch, LLC
Decatur, Georgia, 30030
United States
Chicago Headache Center & Research Institute
Chicago, Illinois, 60657
United States
AMR-Baber Research Inc
Naperville, Illinois, 60563
United States
Children's Clinical Research Center at Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
United States
Physicians Research Group
Noblesville, Indiana, 46060
United States
Options Research Group, LLC
Westfield, Indiana, 46074
United States
Meridian Clinical Research, LLC
Sioux City, Iowa, 51106
United States
Integrated Clinical Trial Services
West Des Moines, Iowa, 50265
United States
Clinical Associates Midwest, LLC
Kansas City, Kansas, 55214
United States
Clinical Associates Midwest, LLC
Kansas City, Kansas, 66214
United States
College Park Family Care Center Physicians Group- Neurology Research Dept.
Overland Park, Kansas, 66212
United States
Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"
Lexington, Kentucky, 40504
United States
UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"
Lexington, Kentucky, 40536
United States
University of Kentucky Hospital
Lexington, Kentucky, 40536
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Neurology and Headache Center, Inc.
Shreveport, Louisiana, 71105
United States
Boston Clinical Trials
Boston, Massachusetts, 02131
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
United States
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
Grand Rapids, Michigan, 49503
United States
Corewell Health, Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Outpatient Pediatric Neurology Clinic
Grand Rapids, Michigan, 49503
United States
Spectrum Health Helen Devos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Wellnow Urgent Care and Research
Kalamazoo, Michigan, 49048
United States
Beaumont Hospital Royal Oak Campus
Royal Oak, Michigan, 48073
United States
Precise Research Centers
Flowood, Mississippi, 39232
United States
Sharlin Health Neuroscience Research Center
Ozark, Missouri, 65721
United States
Clinvest Research, LLC
Springfield, Missouri, 65810
United States
Boeson Research
Great Falls, Montana, 59405
United States
Northwest Physicians
Great Falls, Montana, 59405
United States
Boeson Research HLN
Helena, Montana, 59601
United States
Helena Pediatric Clinic P.C.
Helena, Montana, 59601
United States
Boeson Research LLC
Kalispell, Montana, 59901
United States
Blue Moose Pediatrics
Missoula, Montana, 59804
United States
Boeson Research
Missoula, Montana, 59804
United States
Alivation Research, LLC.
Lincoln, Nebraska, 68526
United States
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
United States
Dent Neurosciences Research Center
Amherst, New York, 14226
United States
Prime Global Research, LLC
Bronx, New York, 10456
United States
Northwell Health/ Division of Pediatric Neurology
Lake Success, New York, 11042
United States
NYU Langone Hospital-Long Island, Clinical Research Center
Mineola, New York, 11501
United States
NYU Langone Hospital-Long Island, Pediatric Neurology
Mineola, New York, 11501
United States
New York Neurology Associates
New York, New York, 10003
United States
Mount Sinai Hospital - Pharmacy Department
New York, New York, 10029
United States
Columbia University Medical Center Research Pharmacy
New York, New York, 10032
United States
Columbia University Pediatric Neuromuscular Center
New York, New York, 10032
United States
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
New York, New York, 10032
United States
The Neurological Institute of New York
New York, New York, 10032
United States
North Suffolk Neurology P.C
Port Jefferson Station, New York, 11776
United States
Finger Lakes Clinical Research
Rochester, New York, 14618
United States
New Hope Clinical Research
Charlotte, North Carolina, 28211
United States
Headache Wellness Center, PC
Greensboro, North Carolina, 27405
United States
Headache Wellness Center
Greensboro, North Carolina, 27405
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Akron Children's Hospital
Akron, Ohio, 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Drug Delivery - Cincinnati Children's Hospital IDS - Denise Lagory
Cincinnati, Ohio, 45229
United States
Velocity Clinical Research
Cincinnati, Ohio, 45242
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Wellnow Urgent Care and Research
Columbus, Ohio, 43214
United States
Wellnow Urgent Care and Research
Columbus, Ohio, 43228
United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720
United States
IPS Research Company
Oklahoma City, Oklahoma, 73106
United States
Lynn Institute of Tulsa
Tulsa, Oklahoma, 74135
United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527
United States
Providence Brain & Spine Institute-research coordinator's office
Portland, Oregon, 97225
United States
Providence Health & Services Investigational Drug Services Westside
Portland, Oregon, 97225
United States
Providence Pediatric Neurology
Portland, Oregon, 97225
United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818
United States
Meridian Clinical Research, LLC
Charleston, South Carolina, 29407
United States
Premier Neurology, PC
Greenville, South Carolina, 29605
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, 29615
United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
United States
Holston Medical Group.
Kingsport, Tennessee, 37660
United States
Holston Medical Group
Kingsport, Tennessee, 37660
United States
Holston Medical Group
Kingsport, Tennessee, 37660
United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
United States
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203
United States
Dell Children's Medical Center
Austin, Texas, 78723
United States
Child Neurology Consultants of Austin - South Austin
Austin, Texas, 78749
United States
Child Neurology Consultants of Austin - Central Austin
Austin, Texas, 78757
United States
BioBehavioral Research of Austin
Austin, Texas, 78759
United States
Houston Clinical Trials, LLC
Bellaire, Texas, 77401
United States
Future Search Trials of Dallas, LP
Dallas, Texas, 75231
United States
Children's Medical Center, Dallas
Dallas, Texas, 75235
United States
Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
Dallas, Texas, 75235
United States
Cedar Health Research
Dallas, Texas, 75251
United States
ANESC Research
El Paso, Texas, 79912
United States
ANRC Research
El Paso, Texas, 79912
United States
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034
United States
UTHealth Houston
Houston, Texas, 77030
United States
Pain and Headache Centers of Texas
Houston, Texas, 77054
United States
SCLA Management
Houston, Texas, 77077
United States
Houston Clinical Research,LLC.
Houston, Texas, 77081
United States
NeuroCare Plus
Houston, Texas, 77094
United States
AIM Trials, LLC
Plano, Texas, 75093
United States
JBR Clinical Research
Salt Lake City, Utah, 84107
United States
Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City, Utah, 84107
United States
The University of Vermont Medical Center
Burlington, Vermont, 05401
United States
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
Charlottesville, Virginia, 22902
United States
Pediatric Research of Charlottesville, LLC (Regulatory Only)
Charlottesville, Virginia, 22902
United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
United States
Children's Specialty Group, PLLC, Division of Childhood & Adolescent Neurology
Norfolk, Virginia, 23510
United States
National Clinical Research, Inc.
Richmond, Virginia, 23294
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
Everett, Washington, 98201
United States
Seattle Children's Hospital Investigational Drug Services
Seattle, Washington, 98105
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Seattle Children's Investigational Drug Service
Seattle, Washington, 98105
United States
Clinical Investigation Specialists, Inc
Kenosha, Wisconsin, 53144
United States
University Hospital
Madison, Wisconsin, 53705
United States
University Hospital
Madison, Wisconsin, 53792
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-15
Study Completion Date2029-01-09

Study Record Updates

Study Start Date2021-01-15
Study Completion Date2029-01-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Pediatric Migraine