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NCT03896009 · ClinicalTrials.gov registry record · Phase 3
Maximizing Outcomes in Treating Acute Migraine
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,594
- Enrollment target
NCT03896009: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT03896009 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 1,594 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03896009, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,594 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 meloxicam, rizatriptan, and placebo for the treatment of a migraine attack. This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.
Primary Outcome
Absence of headache pain. AXS-07 vs Placebo.
Interventions
- DRUG Placebo
- DRUG Meloxicam
- DRUG AXS-07 (MoSEIC meloxicam and rizatriptan)
- DRUG Rizatriptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,594 participants |
| Start Date | 2019-03-04 |
| Est. Completion | 2019-12-10 |
| Phase | Phase 3 |
What the finished NCT03896009 record still lists
NCT03896009 is an interventional study that assigns participants to a tested intervention. Its 1,594 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03896009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03896009 about?
NCT03896009 is a clinical study titled "Maximizing Outcomes in Treating Acute Migraine". 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 NCT03896009?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,594 participants. The study started on 2019-03-04. Estimated completion is 2019-12-10.
What interventions are being tested in trial NCT03896009?
The interventions under investigation include: Placebo (DRUG), Meloxicam (DRUG), AXS-07 (MoSEIC meloxicam and rizatriptan) (DRUG), Rizatriptan (DRUG).
Who is sponsoring clinical trial NCT03896009?
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 NCT03896009's enrollment target sits among peer trials
1,594 146th of 2000 higher than 1,854 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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