Individual Patient Esmethadone (REL-1017) Expanded Access Program

August 2, 2024 updated by: Relmada Therapeutics, Inc.
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).

Study Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Relmada Therapeutics, Inc.

Collaborators

Sponsor-Investigator

Investigators

  • Study Director: Marco Pappagallo, MD, Relmada Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REL-1017-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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