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Also known as esmethadone, Esmethadone HCl, d-Methadone
REL-1017 · 6 trials · 4 indications
Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
Subjects with at least one Treatment Emergent Adverse Events (TEAEs)
Spontaneously reported or observed AEs will be recorded and reported throughout the study, and AEs will be elicited using a non-leading question at every visit from Screening through the Day 21 assessment. An AE was any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and may not necessarily have a causal relationship with the administered treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant laboratory abnormality, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of relationship to the medicinal (investigational) product. During the study, an AE could also occur outside the time that the investigational product(s) was given (e.g., during the time from discontinuation of prohibited medications).
Spontaneously reported and observed AEs were recorded throughout the study, and AEs were elicited using a non-leading question at designated time points. Regardless of seriousness, intensity, or presumed relationship to study drug, all AEs were recorded in the source documentation from the time of first contact with the subject (e.g., screening) until the end of the follow-up period of the study. AEs that occurred after medical screening and prior to administration of the first dose of study drug were recorded in the source documentation as baseline signs and symptoms.
| Arm | Type | Description |
|---|---|---|
| REL-1017 | EXPERIMENTAL | A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. |
| Placebo | PLACEBO_COMPARATOR | Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet. |
| REL-1017 25 mg | EXPERIMENTAL | REL-1017 75 mg of powder in 100 mL of Ocean Spray® Diet Cranberry Juice daily on Day 1, 25 mg of powder in 100 mL Ocean Spray® Diet Cranberry Juice daily on Day 2-7. |
| REL-1017 50 mg | EXPERIMENTAL | REL-1017 100 mg of powder in 100 mL of Ocean Spray® Diet Cranberry Juice daily on Day 1, 50 mg of powder in 100 mL Ocean Spray® Diet Cranberry Juice daily on Day 2-7. |
| Arm 1 | PLACEBO_COMPARATOR | 100 mL Ocean Spray® Diet Cranberry Juice |
| Arm 2 | EXPERIMENTAL | REL-1017 25 mg in 100 mL of Ocean Spray® Diet Cranberry Juice |
| Arm 3 | EXPERIMENTAL | REL-1017 50 mg in 100 mL of Ocean Spray® Diet Cranberry Juice |
| Arm 4 | EXPERIMENTAL | REL-1017 75 mg in 100 mL of Ocean Spray® Diet Cranberry Juice |
| Arm 5 | EXPERIMENTAL | REL-1017 100 mg in 100 mL of Ocean Spray® Diet Cranberry Juice |
| Arm 6 | EXPERIMENTAL | REL-1017 150 mg in 100 mL of Ocean Spray® Diet Cranberry Juice |
| Name | Type | Description |
|---|---|---|
| REL-1017 | DRUG | REL-1017 tablet |
| Placebo | DRUG | Placebo tablet |
Inclusion Criteria: * Adults 18 to 65 years, inclusive. * Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD. * Current major depressive episode. Exclusion Criteria: * Any current ...
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REL-1017 is being developed for the treatment of major depressive disorder, where it has been studied both as a monotherapy and as an adjunctive treatment. It has also been evaluated in neuropathic pain. It is an investigational small molecule and has not been approved for any indication.
REL-1017 is being developed by Relmada Therapeutics, Inc., which trades on the Nasdaq under the ticker RLMD. The company has sponsored the clinical program for the drug, including Phase 3 studies in major depressive disorder and an earlier Phase 1 study in neuropathic pain.
REL-1017 has completed Phase 3 clinical development in major depressive disorder. Four trials have been completed in total, three of them Phase 3 studies and one Phase 1 study. The drug remains investigational and has not been approved by the FDA for any indication.
REL-1017 has been studied in four completed trials. These include NCT05081167, a Phase 3 monotherapy study in major depressive disorder; NCT04855760, a Phase 3 safety study in major depressive disorder; NCT04688164, a Phase 3 adjunctive treatment study in major depressive disorder; and NCT03638869, a Phase 1 study in neuropathic pain.
Across the four completed trials, 1,148 participants were enrolled. The Phase 3 monotherapy study NCT05081167 enrolled 232 patients, the Phase 3 safety study NCT04855760 enrolled 627, the Phase 3 adjunctive study NCT04688164 enrolled 227, and the Phase 1 study NCT03638869 enrolled 24 healthy volunteers.
The REL-1017 trials were randomized, double-blind, and placebo-controlled. Participants were 18 years of age or older and included both sexes. The Phase 3 studies in major depressive disorder enrolled patients in the United States, while the Phase 1 neuropathic pain study used healthy volunteers.