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Randomized Study in Children and Adolescents With Migraine: Acute Treatment

NCT ID: NCT04649242
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Pfizer
Conditions: Pediatric Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 2100 participants (Estimated).

What is being studied

Drug: Matching placebo
Intervention: rimegepant sulfate
Drug: Rimegepant/BHV3000

Who may be eligible

Ages: 6 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 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). Exclusion Criteria: 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

Study locations

245 study locations are listed.

Recruiting site status is explicitly provided for 245 locations; 123 are listed as Recruiting.

Countries: Canada, China, Japan, Mexico, Poland, Spain, Sweden, United Kingdom, United States

British Columbia, Canada: 1
Quebec, Canada: 1
Anhui, China: 2
Beijing Municipality, China: 1
Chongqing Municipality, China: 1
Gansu, China: 1
Guangdong, China: 1
Hainan, China: 1
Hebei, China: 2
Henan, China: 1
Hubei, China: 3
Hunan, China: 3
Jiangsu, China: 6
Jilin, China: 1
Ningxia, China: 1
Shaanxi, China: 3
Shandong, China: 2
Sichuan, China: 1
Zhejiang, China: 3
Fukuoka, Japan: 2
Gunma, Japan: 1
Hyōgo, Japan: 2
Ibaraki, Japan: 1
Kagoshima-ken, Japan: 1
Miyagi, Japan: 1
Osaka, Japan: 2
Tokyo, Japan: 2
Mexico City, Mexico: 1
Sinaloa, Mexico: 1
State of Mexico, Mexico: 1

Sample of listed locations

Kelowna Health & Memory Centre — Kelowna BC, British Columbia, V1Y 5A8, Canada — Recruiting
Anhui Provincial Hospital — Hefei, Anhui, 230000, China — Recruiting
" The First Affiliated Hospital of Chongqing Medical University" — Chongqing, Chongqing Municipality, 400042, China — Recruiting
Shenzhen Children's Hospital — Shenzhen, Guangdong, 518034, China — Recruiting
The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, 050000, China — Recruiting
The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, 050004, China — Recruiting
People's Hospital of Zhengzhou — Zhengzhou, Henan, 450000, China — Recruiting
Renmin Hospital of Wuhan University — Wuhan, Hubei, 430060, China — Recruiting
Hunan Children's Hospital — Changsha, Hunan, 410007, China — Recruiting
The Second Xiangya Hospital of Central South University — Changsha, Hunan, 410000, China — Recruiting
The Third Xiangya Hospital of Central South University — Changsha, Hunan, 410013, China — Recruiting
The Second People's Hospital of Lianyungang — Lianyungang, Jiangsu, 222002, China — Recruiting
The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, 215006, China — Recruiting
Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, 214115, China — Recruiting
Wuxi Children's Hospital — Wuxi, Jiangsu, 214023, China — Recruiting
Xuzhou Children's Hospital — Xuzhou, Jiangsu, 221002, China — Recruiting
Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, 212001, China — Recruiting
The First Hospital of Jilin University, Pediatric Neurology — Changchun, Jilin, 130021, China — Recruiting
General Hospital of Ningxia Medical University — Yinchuan, Ningxia, 756000, China — Recruiting
Yan 'an University Xianyang Hospital — Xianyang, Shaanxi, 716000, China — Recruiting
Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, 250013, China — Recruiting
Liaocheng People's Hospital — Liaocheng, Shandong, 252000, China — Recruiting
Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, 310052, China — Recruiting
The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, 325000, China — Recruiting
Lu 'an People's Hospital — Lu'an, China — Recruiting

Study details

Start date: January 15, 2021
Primary completion date: January 9, 2029
Completion date: January 9, 2029
First posted: December 2, 2020

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT04649242
Registry last updated: September 24, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT04649242 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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