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ENROLLING BY INVITATION
NCT07670702
PHASE3

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

Sponsor: Transcend Therapeutics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-06-22

Completion Date

2029-01

Last Updated

2026-09-04

Healthy Volunteers

No

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

Locations (17)

Preferred Research Partners

Little Rock, Arkansas, United States

CalNeuro Research Group

Los Angeles, California, United States

Catalina Research Institute

Montclair, California, United States

Starlight Clinical Research

Evergreen, Colorado, United States

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, United States

Segal Trials

Lauderhill, Florida, United States

Accel Clinical Research

Maitland, Florida, United States

CNS Healthcare

Orlando, Florida, United States

Vitalix Clinical

Worcester, Massachusetts, United States

Arch Clinical Trials

Creve Coeur, Missouri, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Insight Clinical Trials

Independence, Ohio, United States

Flourish Research

Plymouth Meeting, Pennsylvania, United States

Austin Clinical Trial Partners

Austin, Texas, United States

Haracec Clinical Research

El Paso, Texas, United States

Cedar Clinical Research

Draper, Utah, United States

Inner Space Research

Orem, Utah, United States