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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
Conditions: Post Traumatic Stress Disorder
Sex: All
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Transcend Therapeutics
Location: CNS Healthcare Orlando Florida
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.
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.
Source: ClinicalTrials.gov (NCT07670702). StuddyBuddy aggregates publicly available trial information.