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NCT05509400 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 813
- Enrollment target
NCT05509400: Completed Phase 4 study, sponsored by Pfizer.
NCT05509400 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 813 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05509400, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 813 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
Primary Outcome
Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain relief at 2 hours post-dose was defined as pain intensity of none or mild at that time point.
Interventions
- DRUG Placebo
- DRUG Rimegepant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2022-10-18 |
| Est. Completion | 2025-06-10 |
| Phase | Phase 4 |
What the finished NCT05509400 record still lists
NCT05509400 is an interventional study that assigns participants to a tested intervention. The registered 813 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05509400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05509400 about?
NCT05509400 is a clinical study titled "Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use". This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
What is the current status of trial NCT05509400?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 813 participants. The study started on 2022-10-18. Estimated completion is 2025-06-10.
What interventions are being tested in trial NCT05509400?
The interventions under investigation include: Placebo (DRUG), Rimegepant (DRUG).
Who is sponsoring clinical trial NCT05509400?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05509400's enrollment target sits among peer trials
813 95th of 2000 higher than 1,906 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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