An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD
NCT07670702 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-06-26
Summary
This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial.
Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.
Conditions
- Post Traumatic Stress Disorder
Interventions
- DRUG
-
TSND-201
TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks
Sponsors & Collaborators
-
Transcend Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-12-31
- Completion
- 2029-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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