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

A Phase 3 Open-Label Extension Study to Assess the Long-term Safety and Efficacy of TSND-201 for the Treatment of PTSD

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.

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.