CLINICAL TRIALS PROFILE FOR SRX246

Clinical Trials for SRX246

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00910455 ↗	Study of SRX246 Capsules in Healthy Adult Volunteers	Completed	Azevan Pharmaceuticals	Phase 1	This is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246.
NCT01088932 ↗	Multiple Dose Safety Study of SRX246 Capsules in Healthy Volunteers	Completed	Azevan Pharmaceuticals	Phase 1	This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period.
NCT02055638 ↗	Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder	Completed	Azevan Pharmaceuticals	Phase 1/Phase 2	This study is designed to explore the safety and tolerability, and to compare the activity of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will be randomized to either SRX246 or Placebo treatment groups. Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits throughout the trial. The study results will be determined based on any changes observed over the study period.
NCT02507284 ↗	Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	This study evaluates the tolerability, safety and activity of SRX246 in the treatment of irritability in patients with Huntington's disease. Two-thirds of all participants will receive SRX246, while the other third will receive a placebo.
NCT02507284 ↗	Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease	Completed	NeuroNEXT Network	Phase 2	This study evaluates the tolerability, safety and activity of SRX246 in the treatment of irritability in patients with Huntington's disease. Two-thirds of all participants will receive SRX246, while the other third will receive a placebo.
NCT02507284 ↗	Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease	Completed	Azevan Pharmaceuticals	Phase 2	This study evaluates the tolerability, safety and activity of SRX246 in the treatment of irritability in patients with Huntington's disease. Two-thirds of all participants will receive SRX246, while the other third will receive a placebo.
NCT02733614 ↗	Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD	Terminated	U.S. Army Medical Research and Development Command	Phase 2	18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.

Clinical Trial Conditions for SRX246

Condition Name

Condition Name
Intervention	Trials
Anxiety	2
Fear	2
Healthy	2
Anxiety Disorder	1

Condition MeSH

Condition MeSH
Intervention	Trials
Anxiety Disorders	2
Stress Disorders, Post-Traumatic	1
Huntington Disease	1
Disruptive, Impulse Control, and Conduct Disorders	1

Clinical Trial Locations for SRX246

Trials by Country

Trials by Country
Location	Trials
United States	29

Trials by US State

Trials by US State
Location	Trials
New York	3
Maryland	3
Ohio	2
Missouri	2
Illinois	2

Clinical Trial Progress for SRX246

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	2
Phase 1/Phase 2	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Unknown status	2
Terminated	1

Clinical Trial Sponsors for SRX246

Sponsor Name

Sponsor Name
Sponsor	Trials
Azevan Pharmaceuticals	7
National Institute of Mental Health (NIMH)	3
National Institute of Neurological Disorders and Stroke (NINDS)	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	7
NIH	4
U.S. Fed	3