🔎 Trials Near Me

Home › Migraine › NCT05156398

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

RecruitingPhase 3

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

Who can join

Ages 6 to 17 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:

   1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
   2. 6 or more migraine days during the Observation Period
   3. 14 or less headache days during the Observation Period
   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
   5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
   6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
   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.

      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.

Exclusion Criteria:

1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
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. 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. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
7. History of major psychiatric disorder.
8. The subject has a current diagnosis or history of substance abuse
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.

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 640 · Started: Feb 28, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05156398

Locations in the U.S.

CaliforniaAdvanced Investigative Medicine, Inc., Hawthorne
District of ColumbiaVelocity Clinical Research, Washington DC, Washington D.C.
FloridaDirect Helpers Research Center, Hialeah
D&H Tamarac Research Center LLC, Tamarac
Santos Research Center, CORP, Tampa
GeorgiaAugusta University, Augusta
Clinical Trial Office, Augusta
IdahoNorthwest Clinical Trials, Inc., Boise
LouisianaNola Research Works, LLC, New Orleans
MichiganNRST - Detroit, Detroit (Not yet recruiting)
MinnesotaClinical Research Institute, Minneapolis (Not yet recruiting)
MissouriRoy Blunt NextGen Precision Health Building, Columbia
University of Missouri, Columbia
University of Missouri Health Care - Investigation Pharmacy, Columbia
University of Missouri-Clinical and Translational Sciences Unit, Columbia
NebraskaVelocity Clinical Research, Grand Island, Grand Island
Papillion Research Center/CCT Research, Papillion
New YorkMontefiore Medical Center, The Bronx
OhioCincinnati Children's Hospital Medical Center, Cincinnati
South DakotaAvera McKennan Hospital & University Health Center, Sioux Falls
Avera Medical Group Pediatrics - Dawley Farm, Sioux Falls
Avera Research Institute, Sioux Falls
TexasAlina Clinical Trials, LLC., Dallas
North Texas Center for Clinical Research, Frisco
DM Clinical Research - Cy Fair, Houston
NeuroCare Plus, Houston
SCLA Management - Drop Box, Houston
SCLA Management Office, Houston
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials, McAllen
DCT-Stone Oak, LLC dba Discovery Clinical Trials, San Antonio
DM Clinical Research (Administrative Office Only), Tomball

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.