Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

April 10, 2024 updated by: Pfizer

Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of age).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Karkow, Poland, 31-503
        • Recruiting
        • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
      • Katowice, Poland, 10-123
        • Recruiting
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
      • Katowice, Poland, 40-123
        • Terminated
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
      • Krakow, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Contact:
      • Krakow, Poland, 31-503
        • Recruiting
        • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
      • Kraków, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
      • Poznań, Poland, 61-731
        • Recruiting
        • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k
      • Poznań, Poland, 60-848
        • Recruiting
        • Clinical Research Center Sp. z o.o.
      • Szczecin,, Poland, 70-111,
        • Recruiting
        • Euromedis Sp. z o.o. Osrodek B
      • Wroclaw, Poland, 52-416
        • Recruiting
        • Centrum Medyczne Oporów
      • Wroclaw, Poland, 52-210
        • Recruiting
        • Pracownia Badan Klinicznych SALUS
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall dHebron
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08550
        • Active, not recruiting
        • CAP Balenyà
      • Madrid, Spain, 28036
        • Recruiting
        • Instituto de Investigaciones del Sueño
        • Contact:
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio (HUVR)
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
    • Barcelona
      • Balenya, Barcelona, Spain, 08550
        • Active, not recruiting
        • Centre Atencio Primaria (CAP) Balenya
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Not yet recruiting
        • Hospital Universitario Marques de Valdecilla
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Recruiting
        • Perseverance Research Center, LLC
      • Scottsdale, Arizona, United States, 85253
        • Recruiting
        • Perseverance Research Center, LLC
      • Tempe, Arizona, United States, 85284
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc.
        • Contact:
      • Banning, California, United States, 92220
        • Recruiting
        • Velocity Clinical Research- Banning
      • Chula Vista, California, United States, 91910
      • Culver City, California, United States, 90230
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro-Pain Medical Center
      • Lafayette, California, United States, 94549
        • Recruiting
        • Sunwise Clinical Research
        • Contact:
      • Los Angeles, California, United States, 90057
        • Recruiting
        • National Research Institute
      • Los Angeles, California, United States, 90027
        • Not yet recruiting
        • Children's Hospital Los Angeles, Division of Neurology
      • Los Angeles, California, United States, 90027
        • Not yet recruiting
        • Children's Hospital Los Angeles - Children's Hospital Los Angeles Dept of Pharmacy
      • North Hollywood, California, United States, 91606
      • Pomona, California, United States, 91767
        • Recruiting
        • The Neurology Group
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis Clinical and Translational Science Center Clinical Research Center
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis Midtown Clinic
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Rady Children's Hospital
      • Upland, California, United States, 91786
        • Recruiting
        • Pacific Clinical Research Management Group LLC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado Investigational Drug Services
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado- Investigational Drug Services
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Colorado Springs Neurological Associates
        • Contact:
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • Dinosaur Pediatrics
      • Grand Junction, Colorado, United States, 81505
        • Recruiting
        • Boeson Research - Grand Junction, CO
      • Grand Junction, Colorado, United States, 81501
        • Terminated
        • Boeson Research GJT
      • Grand Junction, Colorado, United States, 81501
        • Terminated
        • Dinosaur Pediatrics
      • Grand Junction, Colorado, United States, 81505
        • Terminated
        • Boeson Research GJT
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • Ki Health Partners, LLc, dba New England Institute for Clinical Research
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Sarkis Clinical Trials
        • Contact:
      • Lake City, Florida, United States, 32055
        • Recruiting
        • Multi-Specialty Research Associates, Inc.
      • Miami, Florida, United States, 33126
        • Recruiting
        • AppleMed Research Group, LLC
      • Miami, Florida, United States, 33176
      • Miami, Florida, United States, 33134
        • Active, not recruiting
        • Medical Research Center of Miami II, Inc
      • Miami Springs, Florida, United States, 33166
      • Orange Park, Florida, United States, 32073
        • Recruiting
        • Coastal Clinical Research Specialists
        • Contact:
      • Orlando, Florida, United States, 32806
        • Not yet recruiting
        • Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
      • Orlando, Florida, United States, 32806
        • Not yet recruiting
        • Orlando Health Arnold Palmer Hospital for Children
      • Tampa, Florida, United States, 33613
        • Recruiting
        • ForCare Clinical Research
        • Contact:
      • West Palm Beach, Florida, United States, 33407
        • Active, not recruiting
        • Premiere Research Institute at Palm Beach Neurology
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Rare Disease Research LLC
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
      • Brunswick, Georgia, United States, 31520
        • Recruiting
        • Pivotal Clinical Research & Associates, LLC
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Chicago Headache Center & Research Institute
      • Chicago, Illinois, United States, 10028
        • Recruiting
        • Chicago Headache Center & Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children at IU Health
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Children's Clinical Research Center at Riley Hospital for Children at IU Health
      • Noblesville, Indiana, United States, 46060
        • Recruiting
        • Physicians Research Group (Administrative Office Location)
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Recruiting
        • College Park Family Care Center Physician Service Group - Neruology Research Department
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Terminated
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research Corporation
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • Michigan Head Pain and Neurological Institute
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Outpatient Pediatric Neurology Clinic
      • Kalamazoo, Michigan, United States, 49048
        • Terminated
        • Wellnow Urgent Care and Research
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Hospital, Royal Oak Campus
    • Missouri
      • Ozark, Missouri, United States, 65721
        • Recruiting
        • Sharlin Health Neuroscience Research Center
        • Contact:
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinvest Research, LLC
      • Springfield, Missouri, United States, 65810
        • Recruiting
        • Clinvest Research, LLC
    • Montana
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Boeson Research
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Northwest Physicians
      • Helena, Montana, United States, 59601
        • Recruiting
        • Boeson Research (HLN)
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Boeson Research,LLC
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Terminated
        • Alivation Research, LLC
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Not yet recruiting
        • HMH Jersey Shore University Medical Center
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurosciences Research Center
      • New York, New York, United States, 10003
      • New York, New York, United States, 10032
        • Recruiting
        • The Neurological Institute of New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center Research Pharmacy
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Pediatric Neuromuscular Center
      • New York, New York, United States, 10032
        • Recruiting
        • Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
      • New York, New York, United States, 10028
        • Not yet recruiting
        • Mount Sinai Hospital - Pharmacy Department
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital - Pharmacy Department
      • Port Jefferson Station, New York, United States, 11776
        • Recruiting
        • North Suffolk Neurology
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Headache Wellness Center, PC
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Atrium Health Wake Forest Baptist
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Velocity Clinical Research - Cincinnati
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Drug Delivery-Cincinnati Children's IDS Denise Lagory
      • Cincinnati, Ohio, United States, 45215
        • Active, not recruiting
        • Wellnow Urgent Care and Research
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Wellnow Urgent Care and Research
        • Contact:
      • Columbus, Ohio, United States, 43228
        • Recruiting
        • Wellnow Urgent Care and Research
      • Dayton, Ohio, United States, 45424
        • Recruiting
        • Wellnow Urgent Care and Research
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Active, not recruiting
        • IPS Research Company
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Recruiting
        • Velocity Clinical Research, Grants Pass
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Health & Services Investigational Drug Services Westside
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Brain & Spine Institute-research coordinator's office
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research-Providence
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Tribe Clinical Research LLC
        • Contact:
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Velocity Clinical Research- Greenville
      • Greer, South Carolina, United States, 29650
        • Active, not recruiting
        • Premier Neurology
      • North Charleston, South Carolina, United States, 29405
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Recruiting
        • Novaceut Clinical Research
        • Contact:
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Childrens Hospital - Outpatient Building
      • Nashville, Tennessee, United States, 37203
        • Terminated
        • Access Clinical Trials, Inc.
    • Texas
      • Austin, Texas, United States, 78749
        • Recruiting
        • Child Neurology Consultants of Austin - South Austin
      • Austin, Texas, United States, 78757
        • Recruiting
        • Child Neurology Consultants of Austin - Central Austin
      • Austin, Texas, United States, 78723
        • Not yet recruiting
        • Dell Children's Medical Center
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Houston Clinical Trials, LLC
      • Dallas, Texas, United States, 75251
      • El Paso, Texas, United States, 79912
        • Recruiting
        • ANRC Research
        • Contact:
      • Frisco, Texas, United States, 75034
        • Recruiting
        • North Texas Institute of Neurology and Headache
      • Frisco, Texas, United States, 75034
        • Active, not recruiting
        • North Texas Institute of Neurology and Headache
      • Houston, Texas, United States, 77054
        • Recruiting
        • Pain and Headache Centers of Texas
        • Contact:
      • Houston, Texas, United States, 77008
        • Recruiting
        • Trio Clinical Trials, LLC.
      • Houston, Texas, United States, 77079
        • Recruiting
        • SCLA Management
      • Houston, Texas, United States, 77081
        • Terminated
        • Houston Clinical Research,LLC.
      • Plano, Texas, United States, 75093
        • Recruiting
        • AIM Trials, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • JBR Clinical Research
        • Contact:
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Wasatch Clinical Research , LLC(Administrative Location)
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
      • Norfolk, Virginia, United States, 23510
        • Recruiting
        • Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology
      • Richmond, Virginia, United States, 23294
        • Terminated
        • National Clinical Research, Inc.
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
      • Everett, Washington, United States, 98201
        • Not yet recruiting
        • Eastside Therapeutic Resource, Inc. dba Core Clinical Research
      • Seattle, Washington, United States, 98105
        • Not yet recruiting
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98105
        • Not yet recruiting
        • Seattle Children's Hospital Investigational Drug Services
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin-Madison
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University Hospital

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.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. History of migraine (with or without aura) for ≥ 6 months before Screening
  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment.
  3. 1 or more migraine days requiring treatment during the Observation Phase.
  4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit
  5. Ability to distinguish between migraine and other types of headaches.
  6. Weight ≥ 40 kg at the Screening Visit.
  7. Adequate venous access for blood sampling.
  8. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome
  3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
  4. History of suicidal behavior or major psychiatric disorder.
  5. Current diagnosis or history of substance abuse; positive drug test at Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rimegepant / BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Drug: Rimegepant / BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of treatment-emergent adverse events, serious adverse events
Time Frame: 58 weeks
To evaluate the safety and tolerability of rimegepant in children and adolescents (≥ 6 to < 18 years of age).
58 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

May 5, 2027

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV3000-312
  • C4951003 (Other Identifier: Alias Study Number)
  • 2020-003761-18 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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