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

Part of paid clinical trials in Little Rock, Arkansas.

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

First listed
Jun 26, 2026
Start date
Jun 22, 2026
Status verified
Sep 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 (17)

FacilityCityStateZIPSite coordinators
Preferred Research PartnersLittle RockArkansas72211-
CalNeuro Research GroupLos AngelesCalifornia90025-
Catalina Research InstituteMontclairCalifornia91763-
Starlight Clinical ResearchEvergreenColorado80439-
Clinical Neuroscience Solutions - JacksonvilleJacksonvilleFlorida32256-
Segal TrialsLauderhillFlorida33319-
Accel Clinical ResearchMaitlandFlorida32751-
CNS HealthcareOrlandoFlorida32801-
Vitalix ClinicalWorcesterMassachusetts01608-
Arch Clinical TrialsCreve CoeurMissouri63141-
Bio Behavioral HealthToms RiverNew Jersey08755-
Insight Clinical TrialsIndependenceOhio44131-
Flourish ResearchPlymouth MeetingPennsylvania19462-
Austin Clinical Trial PartnersAustinTexas78737-
Haracec Clinical ResearchEl PasoTexas79902-
Cedar Clinical ResearchDraperUtah84020-
Inner Space ResearchOremUtah84058-

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By specialty
PsychiatryMental healthBehavioral health
By research site
Preferred Research Partners· Little Rock, ARCalNeuro Research Group· Los Angeles, CACatalina Research Institute· Montclair, CAStarlight Clinical Research· Evergreen, COClinical Neuroscience Solutions - Jacksonville· Jacksonville, FLSegal Trials· Lauderhill, FL

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