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NCT05557409 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 408
- Enrollment target
NCT05557409 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 408 participants.
The verdict
NCT05557409, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 408 participants
- Enrollment target
Study Summary
This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
Interventions
- DRUG Placebo
- DRUG AXS-05
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2024-12-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05557409
The ClinicalTrials.gov registry entry for NCT05557409 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 408 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.
NCT05557409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05557409 about?
NCT05557409 is a clinical study titled "A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation". This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.
What is the current status of trial NCT05557409?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2022-09-06. Estimated completion is 2024-12-21.
What interventions are being tested in trial NCT05557409?
The interventions under investigation include: Placebo (DRUG), AXS-05 (DRUG).
Who is sponsoring clinical trial NCT05557409?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
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