An Evaluation of the Long-Term Safety and Efficacy of TSN... | NCT07670702

Studies
An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSD

NCT07670702

Sponsor

Transcend Therapeutics

Status

Enrolling by invitation

Last Update Posted

Jun 26, 2026Actual

Enrollment

300Estimated

Phase

Phase 3

Conditions

Post Traumatic Stress Disorder

Interventions

TSND-201

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Jun 19, 2026

First Submission Date that Met QC Criteria

Jun 19, 2026

First Posted Date

Jun 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2026

Last Update Posted Date

Jun 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TSND-201	Experimental		Drug: TSND-201

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TSND-201	Drug	TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks	TSND-201

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CNS Healthcare		Orlando	Florida	32801	United States

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided