DNS-3379 vs. Placebo in Stroke Rehabilitation
- Registration Number
- NCT03254160
- Lead Sponsor
- Dart NeuroScience, LLC
- 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-3379 on upper extremity motor recovery in subjects following ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DNS-3379 (0.5mg) DNS-3379 - DNS-3379 (2.5mg) DNS-3379 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Type and incidence of treatment emergent adverse events 84-days Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D 42-days Safety Laboratory Assessments 84-days Vital signs and 12-lead ECG 84-days
- Secondary Outcome Measures
Name Time Method Nine-Hole Peg Test 84-days EQ-5D-5L 84-days Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D) 84-days Modified Rankin Scale 84-days Columbia Suicide Severity Rating Scale 84-days Action Research Arm Test 84-days Stroke Impact Scale 84-days Change in weight 84-days Two-Minute Walk Test 84-days
Trial Locations
- Locations (16)
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
Lyell McEwin
🇦🇺Elizabeth Vale, South Australia, Australia
Repatriation General Hospital
🇦🇺Daw Park, South Australia, Australia
The Alfred
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Albury/Wodonga Hospital
🇦🇺Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Auckland Hospital
🇳🇿Auckland, New Zealand
Hollywood Hospital
🇦🇺Nedlands, Western Australia, Australia
Western Health
🇦🇺St Albans, Victoria, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St Vincents Melbourne
🇦🇺Fitzroy, Victoria, Australia