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Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
NCT05156398 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rimegepant
Study Locations (20)
Florida
- Accel Research Sites Network - Edgewater Clinical Research Unit — Edgewater
- Direct Helpers Research Center — Hialeah
- New Med Research, Inc — Hollywood
- Complete Health Research — Ormond Beach
- D&H Tamarac Research Center LLC — Tamarac
- Santos Research Center, CORP — Tampa
Georgia
- Augusta University — Augusta
- WR-Mount Vernon Clinical Research, LLC — Sandy Springs
- Meridian Clinical Research, LLC — Savannah
- Extraordinary Family Healthcare — Snellville
- Renew Health Clinical Research LLC — Snellville
California
- Advanced Investigative Medicine, Inc. — Hawthorne
- Velocity Clinical Research San Diego — La Mesa
Colorado
- Colorado Springs Neurological Associates — Colorado Springs
- Advanced Neurosciences Research, LLC — Fort Collins
Arkansas
- The Belinga Clinic — Fort Smith
District of Columbia
- Meridian Clinical Research, LLC — Washington D.C.
Idaho
- Northwest Clinical Trials, Inc. — Boise
Illinois
- Diamond Headache Clinic — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2032-11-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05156398
The ClinicalTrials.gov registry entry for NCT05156398 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 640 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05156398 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Georgia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05156398 about?
NCT05156398 is a clinical study titled "Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects". 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 the current status of trial NCT05156398?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 640 participants. The study started on 2022-02-28. Estimated completion is 2032-11-27.
What conditions does trial NCT05156398 study?
This clinical trial studies the following conditions: Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05156398?
The interventions under investigation include: Placebo (DRUG), Rimegepant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05156398?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05156398 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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