An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD - Trial NCT06237426
Access comprehensive clinical trial information for NCT06237426 through Pure Global AI's free database. This Phase 2 trial is sponsored by Transcend Therapeutics and is currently Not yet recruiting. The study focuses on Post Traumatic Stress Disorder. Target enrollment is 150 participants.
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Study Focus
Sponsor & Location
Transcend Therapeutics
Timeline & Enrollment
Phase 2
Feb 01, 2024
May 01, 2027
Primary Outcome
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
Summary
This is an extension study of participants who previously completed a Transcend-sponsored
 clinical trial with methylone as a treatment for PTSD (IMPACT-1 or IMPACT-2).
 
 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 methylone
 treatment. After a course of methylone treatment, participants resume observational study
 visits until Week 52.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06237426
Non-Device Trial