Post Traumatic Stress DisorderPhase 3EMPOWER-EXTNCT07670702
An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD
A Phase 3 study testing TSND-201 in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- TSND-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Jun 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites
Austin Clinical Trial Partners
Austin, Texas, 78737
Arch Clinical Trials
Creve Coeur, Missouri, 63141
Cedar Clinical Research
Draper, Utah, 84020
Haracec Clinical Research
El Paso, Texas, 79902
Starlight Clinical Research
Evergreen, Colorado, 80439
Insight Clinical Trials
Independence, Ohio, 44131
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256
Segal Trials
Lauderhill, Florida, 33319
Preferred Research Partners
Little Rock, Arkansas, 72211
CalNeuro Research Group
Los Angeles, California, 90025
Accel Clinical Research
Maitland, Florida, 32751
Catalina Research Institute
Montclair, California, 91763
Inner Space Research
Orem, Utah, 84058
CNS Healthcare
Orlando, Florida, 32801
Flourish Research
Plymouth Meeting, Pennsylvania, 19462
Bio Behavioral Health
Toms River, New Jersey, 08755
Vitalix Clinical
Worcester, Massachusetts, 01608
About this study
Official title: A Phase 3 Open-Label Extension Study to Assess the Long-term Safety and Efficacy of TSND-201 for the Treatment of PTSD
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
- Being tested
- TSND-201
- Keywords
- PTSD, EMPOWER-EXT, Transcend Therapeutics, TSND-201, Neuroplastogen
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSND-201Drug
TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| TSND-201 | Experimental | Not described Receives: Drug: TSND-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start22 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670702
- Sponsor's protocol ID
- TSND201-PTSD-303
- Acronym
- EMPOWER-EXT
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-Label Extension Study to Assess the Long-term Safety and Efficacy of TSND-201 for the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT07670702
- Acronym / sponsor ID
- EMPOWER-EXT / TSND201-PTSD-303
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, EMPOWER-EXT, Transcend Therapeutics, TSND-201, Neuroplastogen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Transcend TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSND-201 | Experimental | Drug: TSND-201 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSND-201TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks | Drug | TSND-201 |
Primary outcome
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Time frame: Up to 48 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TSND-201 in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.