NCT06237426

An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD

A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments With Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Transcend Therapeutics · Industry
• Sex: All
• Age: 18 Years – 71 Years
• Healthy volunteers: Not accepted

Summary

This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD. Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly. Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Methylone	A course of treatment includes 4 weekly doses of TSND-201.

Timeline

• Start date: 2024-03-06
• Primary completion: 2025-10-06
• Completion: 2025-10-06
• First posted: 2024-02-01
• Last updated: 2025-11-25

Locations

9 sites across 3 countries: United States, Ireland, United Kingdom

Regulatory

• FDA-regulated drug study