Children's National

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

Purpose

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).

Condition

Acute Treatment of Migraine

Eligibility

Eligible Ages: Between 6 Years and 17 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Active	rimegepant 75 mg, 50 mg or 35 mg ODT	Drug: Rimegepant (PF-07899801) Rimegepant 75 mg, 50 mg or 35 mg ODT

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20010

More Details

NCT ID: NCT04743141
Status: Recruiting
Sponsor: Pfizer

Study Contact

Pfizer Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.