Ischemic Stroke
Conditions
Keywords
Stroke, Rehabilitation, Ischemic
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.
Interventions
DRUGDNS-3379
DNS-3379
DRUGPlacebo
Placebo
Sponsors
Dart NeuroScience, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type and incidence of treatment emergent adverse events | 84-days |
| Safety Laboratory Assessments | 84-days |
| Vital signs and 12-lead ECG | 84-days |
| Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D | 42-days |
Secondary
| Measure | Time frame |
|---|---|
| Stroke Impact Scale | 84-days |
| Modified Rankin Scale | 84-days |
| Change in weight | 84-days |
| Columbia Suicide Severity Rating Scale | 84-days |
| Two-Minute Walk Test | 84-days |
| EQ-5D-5L | 84-days |
| Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D) | 84-days |
| Nine-Hole Peg Test | 84-days |
| Action Research Arm Test | 84-days |
Other
| Measure | Time frame |
|---|---|
| fMRI Imaging | 84-days |
Countries
Australia, New Zealand
Outcome results
None listed