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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 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 302 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04163185
The ClinicalTrials.gov registry entry for NCT04163185 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 302 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 2 interventions - of which Placebo is the first listed.
NCT04163185 reports 0 study locations.
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.
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