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NCT04634669 · ClinicalTrials.gov registry record · Phase 2
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
A Phase 2 study, sponsored by Axsome Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 181
- Enrollment target
NCT04634669: Clinical Trial Phase 2 study, sponsored by Axsome Therapeutics.
NCT04634669 is a Phase 2 study that was terminated before completion, run by Axsome Therapeutics. The registered enrollment target is 181 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634669, a Phase 2 study, was terminated before completion, sponsored by Axsome Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 181 participants
- Enrollment target
Study Summary
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures
Interventions
- DRUG AXS-05 (dextromethorphan-bupropion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 2 |
Why NCT04634669 stopped before completion
NCT04634669 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 1 intervention - of which AXS-05 (dextromethorphan-bupropion) is the first listed.
NCT04634669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04634669 about?
NCT04634669 is a clinical study titled "Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)". This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures
What is the current status of trial NCT04634669?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2020-09-23. Estimated completion is 2022-03-04.
What interventions are being tested in trial NCT04634669?
The interventions under investigation include: AXS-05 (dextromethorphan-bupropion) (DRUG).
Who is sponsoring clinical trial NCT04634669?
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 NCT04634669's enrollment target sits among peer trials
181 365th of 2000 higher than 1,636 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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