Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2017-11-13
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DNS-3379 (0.5mg)
DNS-3379
DNS-3379
DNS-3379 (2.5mg)
DNS-3379
DNS-3379
Placebo
Placebo
Placebo
Interventions
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DNS-3379
DNS-3379
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Medically stable subjects, with expected survival \> 12 months, who are able to be randomized to study drug beginning between 1 and 52 weeks (i.e., 7 to 365 days) post-stroke.
* Mild to moderately severe upper extremity motor impairment.
* mRS score of 1 to 4 from index stroke.
* Mini Mental State Examination (MMSE) score of ≥ 22.
Exclusion Criteria
* Hemorrhagic stroke. Ischemic stroke with limited hemorrhagic conversion (i.e., petechial hemorrhage or micro-hemorrhage) is acceptable.
* Severe or total sensory loss
* Moderate to severe aphasia and/or severe language deficits
* Excessive spasticity in the affected elbow or change in oral spasticity treatment drugs within 2 weeks before the Screening Visit
* Prior botulinum toxin injection to any portion of the affected arm in the prior 3 months before the Screening Visit
* Major and active neurological, psychiatric, or medical diagnosis that is not adequately controlled and would likely reduce the safety of study participation or impact the subject's ability to comply with study protocol procedures in the opinion of the Investigator
* Any suicidal ideation during the subject's lifetime at any time prior to randomization including childhood (based on subject history), equivalent to type 2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Received an investigational pharmacotherapy therapy within the past 3 months
* Heavy use of any tobacco-smoke emitting products (including but not limited to cigarettes, pipes, and cigars) within 30 days of Baseline.
* Pregnant or lactating females
18 Years
85 Years
ALL
No
Sponsors
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Dart NeuroScience, LLC
INDUSTRY
Responsible Party
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Locations
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John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Repatriation General Hospital
Daw Park, South Australia, Australia
Lyell McEwin
Elizabeth Vale, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
St Vincents Melbourne
Fitzroy, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Western Health
St Albans, Victoria, Australia
Albury/Wodonga Hospital
Wodonga, Victoria, Australia
Hollywood Hospital
Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Auckland Hospital
Auckland, , New Zealand
Countries
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Other Identifiers
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DNS-3379-201
Identifier Type: -
Identifier Source: org_study_id
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