NCT04743141 Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
| NCT ID | NCT04743141 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Acute Treatment of Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2021-04-28 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2021-04-28 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT04743141 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Acute Treatment of Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04743141 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT04743141 currently recruiting?
Yes, NCT04743141 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT04743141 trial being conducted?
This trial is being conducted at Scottsdale, United States, Tempe, United States, Anaheim, United States, Culver City, United States and 11 additional locations.
Who is sponsoring the NCT04743141 clinical trial?
NCT04743141 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 600 participants.
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