Status:
TEMPORARILY_NOT_AVAILABLE
Individual Patient Esmethadone (REL-1017) Expanded Access Program
Lead Sponsor:
Relmada Therapeutics, Inc.
Collaborating Sponsors:
Sponsor-Investigator
Conditions:
Major Depressive Disorder
Depression
Eligibility:
All Genders
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...
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 condit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06009003
Last Update
August 6 2024
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