CLINICAL TRIALS PROFILE FOR NSI-189

Clinical Trials for NSI-189

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01310881 ↗	Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189	Completed	Neuralstem Inc.	Phase 1	This is a subject single blinded, randomized, placebo-controlled, single dose, first-time-in-human study with three or more ascending cohorts.
NCT01520649 ↗	Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects	Completed	Neuralstem Inc.	Phase 1	This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in depressed human subjects study.
NCT02695472 ↗	Study of NSI-189 for Major Depressive Disorder	Unknown status	Neuralstem Inc.	Phase 2	The study will consist of a screening period and a randomized treatment. Approximately 220 subjects who meet eligibility during the screening period will be randomized to initiate a 12-week, double-blind treatment with NSI-189 80 milligrams/day (provided as 40 milligrams twice per day), NSI-189 40 milligrams once a day, or placebo.
NCT02724735 ↗	A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder	Unknown status	Neuralstem Inc.		All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. The study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.

Clinical Trial Conditions for NSI-189

Condition Name

Condition Name
Intervention	Trials
Depression	3
Major Depressive Disorder	2
Brain Injuries, Traumatic	1

Condition MeSH

Condition MeSH
Intervention	Trials
Depression	5
Depressive Disorder	4
Disease	2
Depressive Disorder, Major	2

Clinical Trial Locations for NSI-189

Trials by Country

Trials by Country
Location	Trials
United States	22

Trials by US State

Trials by US State
Location	Trials
California	4
Texas	2
Tennessee	2
Ohio	2
New York	2

Clinical Trial Progress for NSI-189

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Unknown status	2
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for NSI-189

Sponsor Name

Sponsor Name
Sponsor	Trials
Neuralstem Inc.	4
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	4
Other	1