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Enrolling by invitation NCT07670702

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

Phase III Interventional Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TSND-201.
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [Time frame: Up to 48 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • CNS Healthcare — Orlando

Identifiers

NCT: NCT07670702 · TSND201-PTSD-303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗