A Study to Assess the Use of Methylone in the Treatment of Post-Traumatic Stress Disorder (PTSD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Transcend Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

16 Jan 2024 → 19 Feb 2025

Decision date (initial)

2023-09-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Transcend Therapeutics

External identifiers

EU CT number

2023-505874-14-00

ClinicalTrials.gov

NCT05741710

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

PART A: To assess the safety and tolerability of oral methylone administered weekly over 4 weeks in participants with PTSD.
PART:B: To assess the efficacy of methylone in treating PTSD symptoms.

Secondary objectives 2

1. PART A: To assess the efficacy of methylone in treating PTSD symptoms. PART B: To assess the effect of methylone compared to placebo on sleep quality, functional disability, treatment satisfaction, quality of life, and physical function in participants with PTSD.
2. PART A: To assess the effect of methylone on sleep quality, functional disability, treatment satisfaction, quality of life, and physical function in participants with PTSD. PART B: To assess the safety and tolerability of oral methylone compared to placebo administered weekly over 4 weeks in participants with PTSD.

Conditions and MedDRA coding

Post-Traumatic Stress Disorder (PTSD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months. (The PTSD diagnosis will be confirmed at Baseline by the central rater).
2. CAPS-5 score of ‚ ≥35 at Screening and ≥28 at Baseline.
3. Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
4. Proficient in reading and writing in local language sufficient to complete questionnaires.
5. Free from any other clinically significant illness or disease

Exclusion criteria 7

1. Primary diagnosis of any other DSM-5 disorder
2. Body mass index (BMI) <18 kg/m2 or ‚≥40 kg/m2
3. Smokes an average of >10 cigarettes and/or e-cigarettes per day
4. Uncontrolled hypertension at Screening
5. Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
6. Use of an SSRI or other antidepressant within 8 weeks of screening
7. Current or previous history of clinically significant cardiovascular/cerebrovascular conditions

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Part A: Incidence and severity of TEAEs.
2. Part A: Incidence and severity of AESIs.
3. Part A: Change in HR, SBP, DBP and temperature
4. Part A: Clinically significant changes in ECG.
5. Part A: Changes from baseline in clinical laboratory parameters (clinical chemistry, haematology and urinalysis).
6. Part B: Mean change from baseline to Week 10 compared with placebo in CAPS-5 total severity score.

Secondary endpoints 11

1. Part A: Mean change from baseline to week 10 in CAPS-5 (total severity score assessed over 1 week)
2. Part A: Percentage of participants having: - Treatment response, defined as a a. ≥ 10 point reduction on the CAPS-5 from baseline b. 30% improvement from baseline on CAPS-5 c. 50% improvement from baseline on CAPS-5 - Remission, defined as a score of ≤ 11 on the CAPS-5
3. Part A: Mean change from baseline in the following scales: - CGI-S - MADRS - SDS - PCL-5 - PGI-S - BDI-II - WEMWBS - PSQI
4. Part A: Percentage of participants with improvement on the following scales: - PGI-C -CGI-I
5. Part B: Mean change from baseline compared with placebo in the following scales: - CGI-S - MADRS - SDS - PCL-5 - PGI-S - BDI-II - WEMWBS - PSQI
6. Part B: Percentage of participants having: - Treatment response, defined as a a. ≥ 10 point reduction on the CAPS-5 from baseline b. 30% improvement from baseline on CAPS-5 c. 50% improvement from baseline on CAPS-5 - Remission, defined as a score of ≤ 11 on the CAPS-5 - Improvement on the PGI-C - Improvement on the CGI-I
7. Part B: Incidence and severity of TEAEs
8. Part B: Incidence and severity of AESIs
9. Part B: Change in HR, SBP, DBP and temperature during each dosing session
10. Part B: Clinically significant changes in ECG
11. Part B: Changes from baseline in clinical laboratory parameters (clinical chemistry, haematology, and urinalysis)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Transcend Therapeutics Inc.

Sponsor organisation

Transcend Therapeutics Inc.

Address

220 5th Avenue Floor 17

City

New York

Postcode

10001-8026

Country

United States

Scientific contact point

Organisation

Transcend Therapeutics Inc.

Contact name

Amanda Jones

Public contact point

Organisation

Transcend Therapeutics Inc.

Contact name

Amanda Jones

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 48 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications