Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237426
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-08
First Post:
2024-01-23
Brief Title:
An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD
Sponsor:
Transcend Therapeutics
Organization:
Transcend Therapeutics
Study Overview
Official Title:
A 52-Week Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments With Methylone for the Treatment of PTSD IMPACT-EXT Investigation of Methylone for Post-Traumatic Stress Disorder PTSD
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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-EXT
Brief Summary:
This is an extension study of participants who previously completed a Transcend-sponsored clinical trial with methylone as a treatment for PTSD IMPACT-1 or IMPACT-2
Participants will be followed for up to 52 weeks During the 52 week period PTSD symptoms and safety will be assessed monthly
Participants PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met participants may be eligible to receive a course of methylone treatment After a course of methylone treatment participants resume observational study visits until Week 52
Participants will be followed for up to 52 weeks During the 52 week period PTSD symptoms and safety will be assessed monthly
Participants PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met participants may be eligible to receive a course of methylone treatment After a course of methylone treatment participants resume observational study visits until Week 52
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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