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Neurogenic Drug
40 Milligrams NSI-189, total dose daily for Depression
Phase 2
Waitlist Available
Research Sponsored by Neuralstem Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Summary
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.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
CogScreen
Cogstate Brief Battery
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 80 Milligrams NSI-189, total dose dailyExperimental Treatment1 Intervention
One 40 Milligrams NSI-189 tablet twice per day
Group II: 40 Milligrams NSI-189, total dose dailyExperimental Treatment2 Interventions
One 40 Milligrams NSI-189 tablet and 1 placebo tablet per day
Group III: Placebo ArmPlacebo Group1 Intervention
One Placebo tablet, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Neuralstem Inc.Lead Sponsor
6 Previous Clinical Trials
325 Total Patients Enrolled
3 Trials studying Depression
281 Patients Enrolled for Depression
Karl Johe, Ph.D.Study DirectorNeuralstem Inc.
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Depression
220 Patients Enrolled for Depression
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