Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05260541 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
A Phase 2 study, sponsored by Praxis Precision Medicines.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT05260541: Clinical Trial Phase 2 study, sponsored by Praxis Precision Medicines.
NCT05260541 is a Phase 2 study that was terminated before completion, run by Praxis Precision Medicines. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05260541, a Phase 2 study, was terminated before completion, sponsored by Praxis Precision Medicines.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This trial is comprised of a 4-week randomized, double-blind, placebo-controlled treatment period followed by an optional 8-week open-label extension (OLE) period. This trial will evaluate the efficacy and safety of oral PRAX-114 flexibly dosed at 40 to 60 mg for 4 weeks compared to placebo in adults with PTSD. The OLE period consisting of treatment with 40 mg PRAX-114 for 8 weeks will provide additional efficacy and safety data.
Primary Outcome
The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.
Interventions
- DRUG Placebo
- DRUG 40 mg PRAX-114
- DRUG 60 mg PRAX-114 or 40 mg PRAX-114
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2022-09-23 |
| Phase | Phase 2 |
Why NCT05260541 stopped before completion
NCT05260541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05260541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05260541 about?
NCT05260541 is a clinical study titled "A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder". This trial is comprised of a 4-week randomized, double-blind, placebo-controlled treatment period followed by an optional 8-week open-label extension (OLE) period. This trial will evaluate the efficacy and safety of oral PRAX-114 flexibly dosed at 40 to 60 mg for 4 weeks compared to placebo in adul...
What is the current status of trial NCT05260541?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2022-01-25. Estimated completion is 2022-09-23.
What interventions are being tested in trial NCT05260541?
The interventions under investigation include: Placebo (DRUG), 40 mg PRAX-114 (DRUG), 60 mg PRAX-114 or 40 mg PRAX-114 (DRUG).
Who is sponsoring clinical trial NCT05260541?
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 NCT05260541's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI