Status:
TERMINATED
DNS-3379 vs. Placebo in Stroke Rehabilitation
Lead Sponsor:
Dart NeuroScience, LLC
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate the effect of DNS-...
Eligibility Criteria
Inclusion
- Main
- Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in upper extremity deficit that warrants the need for rehabilitation therapy.
- 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.
- Main
Exclusion
- Residual motor deficit from any prior stroke
- 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
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03254160
Start Date
November 13 2017
End Date
December 31 2017
Last Update
February 1 2018
Active Locations (16)
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1
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
2
Royal North Shore Hospital
St Leonards, New South Wales, Australia
3
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
4
Royal Adelaide Hospital
Adelaide, South Australia, Australia