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
• Status: Available

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
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• REL-1017
REL-1017 tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Relmada Therapeutics, Inc.

External Links

•   Expanded Access Policy