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NCT06237426 Clinical Trial

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

Post Traumatic Stress Disorder Clinical Trial

— IMPACT-EXT  

Official title:
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])

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06237426
Other study ID # TSND201-PTSD-203
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date March 6, 2024
Est. completion date May 2027

Study information
Verified date April 2024
Source Transcend Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 150
Est. completion date May 2027
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 71 Years
Eligibility Inclusion Criteria: - Participation in and successful completion of a prior Transcend-sponsored clinical trial with methylone. - Agree to not participate in any other interventional clinical trials for the duration of this study. - Willing and able to provide informed consent. Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methylone
A course of methylone treatment includes weekly oral methylone administrations for up to 4 weeks. Participants may be eligible to receive up to two courses of methylone treatment in this study. After a course of methylone treatment is complete, participants will return to observational study visits.

Locations
Country Name City State
United Kingdom Mirabilis Health Belfast Northern Ireland
United Kingdom Clerkenwell Health London

Sponsors (1)
Lead Sponsor Collaborator
Transcend Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms. Up to 52 weeks
Secondary Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs) Types and rates of adverse events Up to 52 weeks
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