NCT06009003

Individual Patient Esmethadone (REL-1017) Expanded Access Program

• Status: Temporarily Not Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Relmada Therapeutics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Major Depressive Disorder
• Depression

Interventions

Type	Name	Description
DRUG	REL-1017	REL-1017 tablet

Timeline

• First posted: 2023-08-24
• Last updated: 2024-08-06