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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 is a Phase 2 study that has completed, run by Praxis Precision Medicines. The registered enrollment target is 110 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04969510
The ClinicalTrials.gov registry entry for NCT04969510 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Praxis Precision Medicines, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04969510 reports 0 study locations.
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.
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