An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD (IMPACT-EXT)

April 4, 2024 updated by: Transcend Therapeutics

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])

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (Methylone)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
Time Frame: Up to 52 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)
Time Frame: Up to 52 weeks
Types and rates of adverse events
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transcend Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSND201-PTSD-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Traumatic Stress Disorder

Clinical Trials on Methylone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe