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NCT04969510 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
A Phase 2 study, sponsored by Praxis Precision Medicines.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT04969510: Completed Phase 2 study, sponsored by Praxis Precision Medicines.
NCT04969510 is a Phase 2 study that has completed, run by Praxis Precision Medicines. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04969510, a Phase 2 study, has completed, sponsored by Praxis Precision Medicines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD. The study will enroll participants on adjunctive treatment who had an inadequate response to their current antidepressant treatment and participants not currently being treated with pharmacotherapy for MDD. A sub-study to investigate the pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants with MDD will be conducted in a subset of participants at selected research sites with serial PK sampling capabilities.
Primary Outcome
The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
Interventions
- DRUG Placebo
- DRUG 10 mg PRAX-114
- DRUG 20 mg PRAX-114
- DRUG 40 mg PRAX-114
- DRUG 60 mg PRAX-114
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2022-08-02 |
| Phase | Phase 2 |
What the finished NCT04969510 record still lists
NCT04969510 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04969510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04969510 about?
NCT04969510 is a clinical study titled "A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder". This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD. The study will enroll participants on adjunctive treatment who had an inadequate response to their ...
What is the current status of trial NCT04969510?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2021-06-24. Estimated completion is 2022-08-02.
What interventions are being tested in trial NCT04969510?
The interventions under investigation include: Placebo (DRUG), 10 mg PRAX-114 (DRUG), 20 mg PRAX-114 (DRUG), 40 mg PRAX-114 (DRUG), 60 mg PRAX-114 (DRUG).
Who is sponsoring clinical trial NCT04969510?
This trial is sponsored by Praxis Precision Medicines, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04969510's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 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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