An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD
EMPOWER-EXT
A Phase 3 Open-Label Extension Study to Assess the Long-term Safety and Efficacy of TSND-201 for the Treatment of PTSD
1 other identifier
interventional
300
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2026
CompletedStudy Start
First participant enrolled
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
September 4, 2026
September 1, 2026
2.4 years
June 19, 2026
September 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Up to 48 weeks
Study Arms (1)
TSND-201
EXPERIMENTALInterventions
TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks
Eligibility Criteria
You may qualify if:
- Completion of a double-blind Transcend-sponsored clinical trial with TSND-201 (e.g., TSND201-PTSD-301) and considered in good standing with the study site.
- Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
- Agree to not participate in any other interventional clinical trials for the duration of this study.
You may not qualify if:
- Experienced an intolerable side effect following dosing with TSND-201 in the prior study.
- Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
- Change or development of any physical or psychological finding that would make participant unsuitable for study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Preferred Research Partners
Little Rock, Arkansas, 72211, United States
CalNeuro Research Group
Los Angeles, California, 90025, United States
Catalina Research Institute
Montclair, California, 91763, United States
Starlight Clinical Research
Evergreen, Colorado, 80439, United States
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256, United States
Segal Trials
Lauderhill, Florida, 33319, United States
Accel Clinical Research
Maitland, Florida, 32751, United States
CNS Healthcare
Orlando, Florida, 32801, United States
Vitalix Clinical
Worcester, Massachusetts, 01608, United States
Arch Clinical Trials
Creve Coeur, Missouri, 63141, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Insight Clinical Trials
Independence, Ohio, 44131, United States
Flourish Research
Plymouth Meeting, Pennsylvania, 19462, United States
Austin Clinical Trial Partners
Austin, Texas, 78737, United States
Haracec Clinical Research
El Paso, Texas, 79902, United States
Cedar Clinical Research
Draper, Utah, 84020, United States
Inner Space Research
Orem, Utah, 84058, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2026
First Posted
June 26, 2026
Study Start
June 22, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
September 4, 2026
Record last verified: 2026-09