Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215261
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-01-10
Brief Title:
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Sponsor:
Transcend Therapeutics
Organization:
Transcend Therapeutics
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT-2
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 11 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
Part A is open-label and will enroll up to 15 participants with PTSD
Part B is randomized 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None