Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
150
Countries
1
Sites
2
Post-Traumatic Stress Disorder
To evaluate the long-term efficacy of methylone in participants with PTSD.
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
- 13 Jun 2024 → 6 Oct 2025
- Decision date (initial)
- 2024-04-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Transcend Therapeutics
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To evaluate the long-term efficacy of methylone in participants with PTSD.
Secondary objectives 2
- To determine the need for re-treatment with methylone.
- To evaluate the long-term safety of methylone.
Conditions and MedDRA coding
Post-Traumatic Stress Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036316 | Post-traumatic stress disorder | 100000004873 |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- At time of submitting SM-1 this detail has not been decided, but will be communicated at next opportunity via CTIS
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-505874-14-00 | A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD]) | Transcend Therapeutics Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Prior participation in trial number TT-TSND-201 (IMPACT-1)
Exclusion criteria 1
- Any significant change in social or medial history which would preclude participation in this study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 12
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (total severity score; primary efficacy outcome measure)
- PTSD Checklist for DSM-5 (PCL-5)
- Montgomery-Åsberg Depression Rating Scale (MADRS)
- Sheehan Disability Scale (SDS)
- Clinical Global Impression of Improvement (CGI-I)
- Clinical Global Impression of Severity (CGI-S)
- Patient Global Impression of Change (PGI-C)
- Patient Global Impression of Severity (PGI-S)
- Quick Inventory Depressive Symptoms (QIDS)
- Pittsburgh Sleep Quality Index (PSQI)
- Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
- Post-Traumatic Growth Inventory (PTGI)
Secondary endpoints 6
- Columbia-Suicide Severity Rating Scale (C-SSRS)
- Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)
- Adverse events (serious and non-serious) during Methylone treatment
- Vital signs (blood pressure [BP], heart rate, temperature) during Methylone treatment
- Clinical labs (chemistry, haematology, urinalysis) during Methylone treatment
- Electrocardiogram (ECG) during Methylone treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10428389 · Product
- Active substance
- Methylone
- Other product name
- 3,4-methylenedioxy-N-methylcathinone
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- TRANSCEND THERAPEUTICS
- Paediatric formulation
- No
- Orphan designation
- No
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 3
| Organisation | City, country | Duties |
|---|---|---|
| Tcm Groups Inc. ORG-100049149
|
Berkeley Heights, United States | Code 10, Data management, Code 8 |
| TMC Pharma Services Limited ORG-100003679
|
Hook, United Kingdom | Code 12 |
| Eramol Limited ORG-100034061
|
Dublin 15, Ireland | Code 14 |
Sponsor responsibilities
- Article 77 compliance
- Transcend Therapeutics Inc.
- Contact point sponsor
- Transcend Therapeutics Inc.
- Article 77 implementation
- Transcend Therapeutics Inc.
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Ended | 20 | 2 |
| Rest of world
United States, Australia, United Kingdom
|
— | 130 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Ireland | 2024-06-13 | 2025-08-12 | 2024-09-03 |
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
| Title | Submission date | Status | Type |
|---|---|---|---|
| IMPACT-EXT Summary of the Results SUM-136697
|
2026-05-29T16:14:30 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| TSND201-PTSD-203_Lay Summary of Results | 2026-05-29T16:15:08 | Submitted | Laypersons Summary of Results |
Documents 31 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | TSND201-PTSD-203_Lay Summary of Results | n/a |
| Protocol (for publication) | D1_Protocol Clarification memo_1_2023-508381-16 | n/a |
| Protocol (for publication) | D1_Protocol Clarification memo_2_2023-508381-16 | n/a |
| Protocol (for publication) | D1_Protocol SOC_2023-508381-16_REDACTED | 2.0 |
| Protocol (for publication) | D1_Protocol Synopsis_ENG_2023-508381-16_Tracked | 2.0 |
| Protocol (for publication) | D1_Protocol_2023-508381-16_REDACTED | 2.0 |
| Protocol (for publication) | D1_Protocol_2023-508381-16_TRACKED | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-SLV_IRL | 1 |
| Protocol (for publication) | D4_Patient facing documents_CAPS-5_Past Month | 1 |
| Protocol (for publication) | D4_Patient facing documents_CAPS-5_Past Week | 1 |
| Protocol (for publication) | D4_Patient facing documents_CGI-I | 1 |
| Protocol (for publication) | D4_Patient facing documents_CGI-S | 1 |
| Protocol (for publication) | D4_Patient facing documents_MADRS | 1 |
| Protocol (for publication) | D4_Patient facing documents_Patient Contact Card | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PCL-5_Past Week | 1 |
| Protocol (for publication) | D4_Patient facing documents_PGI-C | 1 |
| Protocol (for publication) | D4_Patient facing documents_PGI-S | 1 |
| Protocol (for publication) | D4_Patient facing documents_PSQI | 1 |
| Protocol (for publication) | D4_Patient facing documents_PTGI | 1 |
| Protocol (for publication) | D4_Patient facing documents_QIDS-SR-16 | 1 |
| Protocol (for publication) | D4_Patient facing documents_SDS | 1 |
| Protocol (for publication) | D4_Patient facing documents_WEMWBS | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment and Informed Consent Procedure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Master_GP_Letter | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Extension Study | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Extension Study_TC | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant and Pregnant Partner | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant and Pregnant Partner_TC | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ePRO Participant Interface | 1.0 |
| Summary of results (for publication) | IMPACT-EXT Summary of the Results | n/a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508381-16_REDACTED | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-01 | Ireland | Acceptable 2024-04-02
|
2024-04-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-16 | Ireland | Acceptable 2024-10-11
|
2024-10-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-16 | Ireland | Acceptable 2024-10-11
|
2024-12-16 |