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NCT04163185 · ClinicalTrials.gov registry record · Phase 3
Initiating Early Control of Migraine Pain and Associated Symptoms
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
NCT04163185: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT04163185 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 302 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04163185, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
Study Summary
AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo. This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.
Primary Outcome
Absence of headache pain at Hour 2
Interventions
- DRUG Placebo
- DRUG AXS-07 (MoSEIC meloxicam and rizatriptan)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2020-03-23 |
| Phase | Phase 3 |
What the finished NCT04163185 record still lists
NCT04163185 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04163185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04163185 about?
NCT04163185 is a clinical study titled "Initiating Early Control of Migraine Pain and Associated Symptoms". AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to eva...
What is the current status of trial NCT04163185?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2019-10-08. Estimated completion is 2020-03-23.
What interventions are being tested in trial NCT04163185?
The interventions under investigation include: Placebo (DRUG), AXS-07 (MoSEIC meloxicam and rizatriptan) (DRUG).
Who is sponsoring clinical trial NCT04163185?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04163185's enrollment target sits among peer trials
302 1119th of 2000 higher than 880 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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