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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06215261




Registration number
NCT06215261
Ethics application status
Date submitted
10/01/2024
Date registered
22/01/2024
Date last updated
13/03/2024

Titles & IDs
Public title
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Scientific title
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Secondary ID [1] 0 0
TSND201-PTSD-202
Universal Trial Number (UTN)
Trial acronym
IMPACT-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methylone
Treatment: Drugs - Placebo

Experimental: Methylone -

Placebo Comparator: Placebo -


Treatment: Drugs: Methylone
Methylone capsules, given orally, once a week for 3 weeks

Treatment: Drugs: Placebo
Placebo capsules to match methylone, given orally, once a week for 3 weeks NOTE: Placebo is only in Part B
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
Timepoint [1] 0 0
Up to 9 weeks
Secondary outcome [1] 0 0
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Timepoint [1] 0 0
Up to 9 weeks
Secondary outcome [2] 0 0
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
Timepoint [2] 0 0
Up to 9 weeks
Secondary outcome [3] 0 0
Change from Baseline in Sheehan Disability Scale (SDS)
Timepoint [3] 0 0
Up to 9 weeks
Secondary outcome [4] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [4] 0 0
Up to 9 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
79
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment hospital [2] 0 0
Ramsay Clinic Albert Road - Melbourne
Recruitment hospital [3] 0 0
Monarch Mental Health Group - Melbourne
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Transcend Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06215261
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
+1 (650) 382-2719
Fax 0 0
Email 0 0
alyssa@transcendtherapeutics.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06215261