Clinical trial NCT03254160: DNS-3379 vs. Placebo in Stroke Rehabilitation
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 42-Day Treatment Study to Evaluate the Effect of DNS-3379 on Upper Extremity Motor Function Following Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: Stroke
Rehabilitation
Ischemic
Lead sponsor: Dart NeuroScience, LLC
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D
timeFrame: 42-days
measure: Type and incidence of treatment emergent adverse events
timeFrame: 84-days
measure: Safety Laboratory Assessments
timeFrame: 84-days
measure: Vital signs and 12-lead ECG
timeFrame: 84-days
Secondary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)
timeFrame: 84-days
measure: Nine-Hole Peg Test
timeFrame: 84-days
measure: Action Research Arm Test
timeFrame: 84-days
measure: Stroke Impact Scale
timeFrame: 84-days
measure: Modified Rankin Scale
timeFrame: 84-days
measure: Change in weight
timeFrame: 84-days
measure: Columbia Suicide Severity Rating Scale
timeFrame: 84-days
measure: Two-Minute Walk Test
timeFrame: 84-days
measure: EQ-5D-5L
timeFrame: 84-days
Other outcomes:
measure: fMRI Imaging
timeFrame: 84-days
Locations:
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Daw Park
country: Australia
facility: Repatriation General Hospital
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: St Albans
country: Australia
facility: Western Health
state: Victoria
city: Wodonga
country: Australia
facility: Albury/Wodonga Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland Hospital
Study officials:
References: