Summary

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

Description

Summary

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

Keywords

Pediatric Migraine, Migraine, Acute treatment, Phonophobia, Photophobia, Nausea, Pediatric, Children, Adolescent, Migraine Disorders, Rimegepant/BHV3000

Eligibility

You can join if…

Open to people ages 6-17

  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. 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. 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.
    1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
    2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
    3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
  4. Verbally distinguish between migraine and other types of headaches.
  5. Participants must have a weight > 40 kg at the Screening Visit.
  6. Adequate venous access for blood sampling.
  7. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

You CAN'T join if...

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
  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. History of suicidal behavior or major psychiatric disorder.
  5. Current diagnosis or history of substance abuse; positive drug test at Screening.
  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. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
  8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
  9. Current diagnosis of viral hepatitis or a history of liver disease.

    10. Conditions considered clinically relevant in the context of the study such as

    uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Locations

  • University of California, San Diego Altman Clinical Translational Research Institute accepting new patients
    La Jolla California 92037 United States
  • University of California, Davis Midtown Clinic not yet accepting patients
    Sacramento California 95816 United States
  • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy not yet accepting patients
    Sacramento California 95817 United States
  • University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC) not yet accepting 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 accepting new patients
    North Hollywood California 91606 United States
  • Children's Hospital Los Angeles, Division of Neurology not yet accepting patients
    Los Angeles California 90027 United States
  • Children's Hospital Los Angeles-Children's Hospital Los Angeles Dept of Pharmacy not yet accepting patients
    Los Angeles California 90027 United States
  • National Research Institute in progress, not accepting new patients
    Los Angeles California 90057 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04649242
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 2100 study participants
Last Updated