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

a study on Headache Migraine

Summary

Eligibility
for people ages 6-17 (full criteria)
Location
at UC Davis UCSD
Dates
study started
study ends around

Description

Summary

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).

Official Title

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

Keywords

Acute Treatment of Migraine, Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent, Migraine Disorders, Hyperacusis, Photophobia, Nausea, rimegepant sulfate, Rimegepant (PF-07899801)

Eligibility

You can join if…

Open to people ages 6-17

  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. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg.
  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 on or before the Baseline visit).

You CAN'T join if...

  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.

Locations

  • University of California San Diego, Altman Clinical and Translational Research Institute Clinic accepting new patients
    La Jolla California 92037 United States
  • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy accepting new patients
    Sacramento California 95817 United States
  • University of California, Davis Clinical and Translational Science Center Clinical Research Center accepting new patients
    Sacramento California 95817 United States
  • University of California, Davis Midtown Clinic accepting new patients
    Sacramento California 95817 United States
  • ProScience Research Group accepting new patients
    Culver City California 90230 United States
  • Neuro-Pain Medical Center accepting new patients
    Fresno California 93710 United States
  • Velocity Clinical Research - North Hollywood in progress, not accepting new patients
    North Hollywood California 91606 United States
  • Advanced Research Center, Inc. accepting new patients
    Anaheim California 92805 United States
  • Adult & Child Neurology Medical Associates accepting new patients
    Long Beach California 90806 United States
  • Memorialcare Miller Children's & Women's Hospital Long Beach accepting new patients
    Long Beach California 90806 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT04743141
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated
Contact us about this trial