Individual Patient Esmethadone (REL-1017) Expanded Access Program

NCT06009003 | Unknown

• 1 other identifier: REL-1017-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Major Depressive Disorder; Depression

Keywords

REL-1017; esmethadone; Relmada; antidepressant; NMDA receptor antagonist; Depression

Interventions

REL-1017 DRUG

REL-1017 tablet

Also known as: esmethadone

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who may potentially benefit from treatment with esmethadone (REL-1017) as determined by the treating physician.
• Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition.
• Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
• Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks.

You may not qualify if:

• History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
• History of QTc prolongation.
• History of allergy or hypersensitivity to methadone or related drugs.
• Pregnant or planning to become pregnant.
• Breast-feeding or planning to breast-feed.

Sponsors & Collaborators

• Relmada Therapeutics, Inc.: lead
• Sponsor-Investigator: collaborator

Related Links

• Expanded Access Policy

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Marco Pappagallo, MD

  Relmada Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 24, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08