An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD (IMPACT-2)

Transcend Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Post Traumatic Stress Disorder

Treatments

Drug: Placebo

Drug: Methylone

Study type

Interventional

Funder types

Industry

Identifiers

NCT06215261

TSND201-PTSD-202

Details and patient eligibility

About

This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.

Part A is open-label and will enroll up to 15 participants with PTSD
Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD

Eligible participants will enter a 3-week Treatment Period where they will receive methylone (or placebo in Part B) once weekly for 3 weeks (3 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period.

Enrollment

79 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
CAPS-5 score of at least 35 at Screening.
Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
Proficient in reading and writing in local language sufficient to complete questionnaires.
Free for any other clinically significant illness or disease.

Exclusion criteria

Primary diagnosis of any other DSM-5 disorder.
Body mass index (BMI) <18kg/m2 or ≥40 kg/m2.
Smokes an average of >10 cigarettes and/or e-cigarettes per day.
Uncontrolled hypertension at Screening.
Use of prohibited concomitant medications or therapies.
Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.