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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Transcend Therapeutics
Study ID
NCT07670702
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TSND-201

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CNS HealthcareOrlandoFlorida32801-

Find similar trials in Orlando, FL

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
CNS Healthcare· Orlando, FL

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