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

Description

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

Conditions

Acute Treatment of Migraine

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Acute Treatment of Migraine
Intervention / Treatment

-

Contacts and Locations

Chandler

Physicians Research Group, Chandler, Arizona, United States, 85224

Scottsdale

Perseverance Research Center, LLC, Scottsdale, Arizona, United States, 85253

Scottsdale

Perseverance Research Center, LLC, Scottsdale, Arizona, United States, 85254

Tempe

Physicians Research Group, Tempe, Arizona, United States, 85284

Anaheim

Advanced Research Center, Inc., Anaheim, California, United States, 92805

Banning

Velocity Clinical Research- Banning, Banning, California, United States, 92220

Chula Vista

The Neuron Clinic, Chula Vista, California, United States, 91910

Culver City

ProScience Research Group, Culver City, California, United States, 90230

Fresno

Neuro-Pain Medical Center, Fresno, California, United States, 93710

Lafayette

Sunwise Clinical Research, Lafayette, California, United States, 94549

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 screening.
  • 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 Screening Visit.
  • 5. Ability to distinguish between migraine and other types of headaches.
  • 6. Weight \> 15 kg.
  • 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)
  • 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 at risk of self-harm/harm to others.
  • 5. History of major psychiatric disorder.
  • 6. Current diagnosis or history of substance abuse
  • 7. Reported current use of or tested positive at Screening for drugs of abuse.

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2027-06-09