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NCT06009003 Clinical Trial

REL-1017 Expanded Access Treatment

Depression Clinical Trial

Official title:
REL-1017 Expanded Access Treatment

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT06009003
Other study ID # REL-1017-EAP
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date September 2023
Source Relmada Therapeutics, Inc.
Contact Medical Director
Phone 786-638-7384
Email expandedaccess@relmada.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• REL-1017
REL-1017 tablet

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Relmada Therapeutics, Inc.
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