Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 5:30 PM
Study NCT ID:
NCT06009003
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2024-08-06
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Esmethadone (REL-1017) Expanded Access Program
Sponsor:
Relmada Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Individual Patient Esmethadone (REL-1017) Expanded Access Program
Status:
TEMPORARILY_NOT_AVAILABLE
Status Verified Date:
2024-08
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:
None
Brief Summary:
To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017).
Detailed Description:
The Expanded Access Program (EAP) is intended to provide pre-approval access to esmethadone (REL-1017) for eligible patients who suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) as determined by the treating physician and have no satisfactory treatment options. This program is open in the United States and operates under the Individual Patient (also referred to as Single Patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the Relmada EAP policy at https://www.relmada.com/our-portfolio/eap.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: