A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 21-Day Treatment Study, Including an fMRI Sub-Study, to Evaluate the Effect of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke

Dart NeuroScience, LLC0 sites61 target enrollmentFebruary 2016

ConditionsIschemic Stroke

InterventionsPlacebo HT-3951

DrugsHT-3951 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Ischemic Stroke
Sponsor: Dart NeuroScience, LLC
Enrollment: 61
Primary Endpoint: Fugl-Meyer Assessment of Upper Extremity, Part A-D
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

December 31, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dart NeuroScience, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age range between 21 to 85 years, inclusive, at the Screening Visit
•Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in an upper extremity deficit that, in the opinion of the Investigator, warrants the need for rehabilitation therapy
•Medically stable subjects who are able to be randomized to study medication beginning between ≥ 2 and ≤ 52 weeks post-stroke
•Subjects who have initiated, are undergoing, have completed or agree to begin physical or occupational rehabilitation for at least 2 weeks prior to study Day
•Mild to moderate unilateral upper extremity motor impairment characterized by FMA-EU score of \> 18
•Modified Rankin Scale score of 1 to 4

Exclusion Criteria

•History of stroke within 6 months prior to the subject's current episode of ischemic stroke (History of transient ischemic attacks or ischemic stroke (nonhemorrhagic) more than 6 months prior to the current ischemic stroke are acceptable.)
•Subjects with unresolved upper or lower motor deficits (e.g., range of motion or strength deficits) from any prior stroke
•Significant hemorrhagic stroke
•Any history of seizure disorder or a spontaneous seizure that had occurred at any time after the stroke
•Apraxia that, in the Investigator's opinion, would likely reduce the ability of the subject to participate in the study or confound study outcome measures
•Moderate to severe aphasia and/or severe language deficits
•Severe sensory loss in affected hand
•Moderate to severe hemispatial neglect or anosognosia involving the affected arm
•Absent proprioception at the elbow or shoulder joints
•Excessive spasticity in the affected elbow, defined as a score of greater than or equal to 3 on the Modified Ashworth Spasticity scale (MAS)