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

Phase 3

Recruiting

• Conditions: Acute Treatment of Migraine
• Interventions: Drug: Rimegepant (PF-07899801)

• Registration Number: NCT04743141
• Lead Sponsor: Pfizer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Study Start: 2021-04-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2030-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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).

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	Rimegepant (PF-07899801)	rimegepant 75 mg, 50 mg or 35 mg ODT

Primary Outcome Measures

Name	Time	Method
The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities	58 weeks	To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to \< 18 years of age).

Secondary Outcome Measures

Name	Time	Method
The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation	58 weeks	To evaluate the frequency and severity of hepatic-related adverse events and the frequency of hepatic-related treatment discontinuations in children and adolescents (6 to less than 18 years of age) treated with rimegepant.

Trial Locations

Locations (110)

Perseverance Research Center, LLC; 🇺🇸 Scottsdale, Arizona, United States

Physicians Research Group; 🇺🇸 Tempe, Arizona, United States

Advanced Research Center, Inc.; 🇺🇸 Anaheim, California, United States

ProScience Research Group; 🇺🇸 Culver City, California, United States

Neuro-Pain Medical Center; 🇺🇸 Fresno, California, United States

University of California San Diego, Altman Clinical and Translational Research Institute Clinic; 🇺🇸 La Jolla, California, United States

Sunwise Clinical Research; 🇺🇸 Lafayette, California, United States

Memorialcare Miller Children's & Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

Velocity Clinical Research - North Hollywood; 🇺🇸 North Hollywood, California, United States

The Neurology Group; 🇺🇸 Pomona, California, United States

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