CLINICAL TRIALS PROFILE FOR REL-1017

Clinical Trials for REL-1017

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03051256 ↗	Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD	Completed	INC Research	Phase 2	This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.
NCT03051256 ↗	Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD	Completed	Syneos Health	Phase 2	This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.
NCT03051256 ↗	Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD	Completed	Relmada Therapeutics, Inc.	Phase 2	This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.
NCT03637361 ↗	Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone)	Completed	Relmada Therapeutics, Inc.	Phase 1	This study evaluated the safety, tolerance, and pharmacokinetics (PK) of d-methadone in a limited dose range, in single administrations in humans.
NCT03638869 ↗	Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone)	Completed	Relmada Therapeutics, Inc.	Phase 1	This study evaluated the safety, tolerance, and pharmacokinetics (PK) of d-methadone in a limited dose range, in multiple administrations in humans.
NCT04145674 ↗	A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo	Not yet recruiting	Clinical Trial Unit Ente Ospedaliero Cantonale	Phase 2	Proof of concept, double-blind Randomized Controlled Trial with d-Methadone proposed for the first time for use in the treatment of patients diagnosed with primary, moderate to very severe RLS. Its glutamatergic mechanism of action might be effective on Restless Legs Syndrome arousal pattern and sleep disturbance which highly impair the quality of life of Restless Legs Syndrome's patients. Patients must take study drug once a day for 10 consecutive days.
NCT04145674 ↗	A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo	Not yet recruiting	Mauro Manconi	Phase 2	Proof of concept, double-blind Randomized Controlled Trial with d-Methadone proposed for the first time for use in the treatment of patients diagnosed with primary, moderate to very severe RLS. Its glutamatergic mechanism of action might be effective on Restless Legs Syndrome arousal pattern and sleep disturbance which highly impair the quality of life of Restless Legs Syndrome's patients. Patients must take study drug once a day for 10 consecutive days.

Clinical Trial Conditions for REL-1017

Condition Name

Condition Name
Intervention	Trials
Major Depressive Disorder	5
Neuropathic Pain	2
Restless Legs Syndrome	1
Depression	1

Condition MeSH

Condition MeSH
Intervention	Trials
Depressive Disorder, Major	6
Depressive Disorder	6
Depression	6
Neuralgia	2

Clinical Trial Locations for REL-1017

Trials by Country

Trials by Country
Location	Trials
United States	74
Switzerland	1
Italy	1

Trials by US State

Trials by US State
Location	Trials
Florida	5
California	5
Arkansas	5
Texas	5
New Jersey	4

Clinical Trial Progress for REL-1017

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	5
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for REL-1017

Sponsor Name

Sponsor Name
Sponsor	Trials
Relmada Therapeutics, Inc.	8
Syneos Health	1
Clinical Trial Unit Ente Ospedaliero Cantonale	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	8
Other	4