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: 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 (1:1:1), single-blind and will enroll up to 45 participants with PTSD

Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).

Enrollment: 60 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.
• Tried at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
• Proficient in reading and writing in local language sufficient to complete questionnaires.
• Free from 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

TSND-201 Low Dose

Experimental group

Description:

Part B only

Treatment:

Drug: Methylone

TSND-201 Mid Dose

Experimental group

Description:

Part B only

Treatment:

Drug: Methylone

TSND-201 High Dose

Experimental group

Description:

Part B only

Treatment:

Drug: Methylone