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REL-1017 Expanded Access Treatment

Primary Purpose

Major Depressive Disorder, Depression

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
REL-1017
Sponsored by
Relmada Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Major Depressive Disorder focused on measuring REL-1017, esmethadone, Relmada, antidepressant, NMDA receptor antagonist, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Patients with Major Depressive Disorder who may potentially benefit from treatment with 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. There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc. 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 allergy or hypersensitivity to methadone or related drugs. Pregnant or planning to become pregnant. Breast-feeding or planning to breast-feed.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Relmada Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06009003
    Brief Title
    REL-1017 Expanded Access Treatment
    Official Title
    REL-1017 Expanded Access Treatment
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Relmada Therapeutics, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    To provide expanded access of REL-1017 to patients with MDD who do not have access to other effective therapy and are not eligible for other clinical trials with REL-1017

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder, Depression
    Keywords
    REL-1017, esmethadone, Relmada, antidepressant, NMDA receptor antagonist, Depression

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    REL-1017
    Other Intervention Name(s)
    esmethadone
    Intervention Description
    REL-1017 tablet

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patients with Major Depressive Disorder who may potentially benefit from treatment with 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. There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc. 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 allergy or hypersensitivity to methadone or related drugs. Pregnant or planning to become pregnant. Breast-feeding or planning to breast-feed.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Medical Director
    Phone
    786-638-7384
    Email
    expandedaccess@relmada.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cedric O'Gorman, MD
    Organizational Affiliation
    Relmada Therapeutics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://www.relmada.com/our-portfolio/eap
    Description
    Expanded Access Policy

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