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
• Status: Enrolling by invitation
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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