MedTrace Logo

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

NCT05156398 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Rimegepant

Rimegepant 75mg or 50mg (2 X 25mg) ODT

DRUG

Placebo

Matching placebo 75mg or 50mg (2 X 25mg) ODT

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2031-11-29
Completion
2032-11-27
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Japan
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156398 on ClinicalTrials.gov