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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 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 1,594 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03896009
The ClinicalTrials.gov registry entry for NCT03896009 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,594 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03896009 reports 0 study locations.
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.
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