RECRUITING

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

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Conditions

MigraineMigraine preventionPhonophobiaPhotophobiaNauseaPediatric migraineAdolescent migraine

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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 compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

Quick Facts

Study Start:2022-02-28
Study Completion:2027-04-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05156398

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. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
  2. 1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
  3. 2. 6 or more migraine days during the Observation Period
  4. 3. 14 or less headache days during the Observation Period
  5. 4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
  6. 5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
  7. 6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
  8. 7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent.
  1. 1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
  2. 2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
  3. 3. The subject has a history or diagnosis of complications of migraine
  4. 4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
  5. 5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
  6. 6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
  7. 7. History of major psychiatric disorder.
  8. 8. The subject has a current diagnosis or history of substance abuse
  9. 9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

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)

The Belinga Clinic
Fort Smith, Arkansas, 72901
United States
The Belinga Clinic
Fort Smith, Arkansas, 72901
United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250
United States
Velocity Clinical Research San Diego
La Mesa, California, 91942
United States
Clinical Research of California
Walnut Creek, California, 94598
United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528
United States
Meridian Clinical Research, LLC
Washington, District of Columbia, 20016
United States
Synergy Healthcare
Bradenton, Florida, 34208
United States
Vertex Research Group
Clermont, Florida, 34711
United States
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, 32132
United States
Complete Health Research
Edgewater, Florida, 32132
United States
Direct Helpers Research Center
Hialeah, Florida, 33012
United States
New Med Research, Inc
Hollywood, Florida, 33020
United States
Axcess Medical Research
Loxahatchee Groves, Florida, 33470
United States
Sanitas Research, LLC
Miami, Florida, 33155
United States
APG Research, LLC
Orlando, Florida, 32803
United States
Complete Health Research
Ormond Beach, Florida, 32174
United States
D&H Tamarac Research Center LLC
Tamarac, Florida, 33321
United States
Santos Research Center, CORP
Tampa, Florida, 33615
United States
Augusta University
Augusta, Georgia, 30912
United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
United States
Extraordinary Family Healthcare
Snellville, Georgia, 30078
United States
Renew Health Clinical Research LLC
Snellville, Georgia, 30078
United States
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704
United States
Diamond Headache Clinic
Chicago, Illinois, 60642
United States
Safe Haven Clinical Research
Clinton, Mississippi, 39056
United States
University of Missouri - Investigational Pharmacy
Columbia, Missouri, 65212
United States
University of Missouri Health Care - Clinical Research Center
Columbia, Missouri, 65212
United States
University of Missouri Health Care - Investigation Pharmacy (IP to be shipped here)
Columbia, Missouri, 65212
United States
University of Missouri Health Care - Pathology Department
Columbia, Missouri, 65212
United States
University of Missouri
Columbia, Missouri, 65212
United States
Velocity Clinical Research, Inc.
Grand Island, Nebraska, 68003
United States
Meridian Clinical Research, LLC
Hastings, Nebraska, 68901
United States
Velocity Clinical Research, Inc.
Hastings, Nebraska, 68901
United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68504
United States
Papillion Research Center/CCT Research
Papillion, Nebraska, 68046
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Ocean Medical Research
Toms River, New Jersey, 08755
United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109
United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, 28303
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Velocity Clinical Research
Cincinnati, Ohio, 45242
United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
United States
Meridian Clinical Research, LLC
Charleston, South Carolina, 29407
United States
Coastal Pediatric Research
Charleston, South Carolina, 29414
United States
Tribe Clinical Research LLC
Greenville, South Carolina, 29607
United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105
United States
Avera Medical Group Pediatric Specialists
Sioux Falls, South Dakota, 57105
United States
Avera Research Institute
Sioux Falls, South Dakota, 57108
United States
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
DCT-Baxter Research, LLC dba Discovery Clinical Trials
Dallas, Texas, 75225
United States
North Texas Center for Clinical Research
Frisco, Texas, 75034
United States
DM Clinical Research - Cy Fair
Houston, Texas, 77065
United States
SCLA Management - Drop Box
Houston, Texas, 77077
United States
SCLA Management Office
Houston, Texas, 77077
United States
SCLA Management
Houston, Texas, 77079
United States
NeuroCare Plus
Houston, Texas, 77094
United States
Red Star Research, LLC
Lake Jackson, Texas, 77566
United States
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503
United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258
United States
Texas Institute for Neurological Disorders
Sherman, Texas, 75092
United States
DM Clinical Research (Administrative Office Only)
Tomball, Texas, 77375
United States
Victoria Clinical Research Group
Victoria, Texas, 77901
United States
South Ogden Family Medicine Ogden Clinic/CCT Research
South Ogden, Utah, 84405
United States
Meridian Clinical Research, LLC
Portsmouth, Virginia, 23703
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 Date2022-02-28
Study Completion Date2027-04-29

Study Record Updates

Study Start Date2022-02-28
Study Completion Date2027-04-29

Terms related to this study

Keywords Provided by Researchers

  • Migraine
  • Migraine prevention
  • Phonophobia
  • Photophobia
  • Nausea
  • Pediatric migraine
  • Adolescent migraine

Additional Relevant MeSH Terms

  • Migraine