DNS-3379 vs. Placebo in Stroke Rehabilitation (SPIRIT)

Dart NeuroScience

Status and phase

Terminated

Phase 2

Conditions

Ischemic Stroke

Treatments

Drug: DNS-3379

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03254160

DNS-3379-201

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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