HT-3951 vs. Placebo in Stroke Rehabilitation (RESTORE)

Dart NeuroScience

Status and phase

Terminated

Phase 2

Conditions

Ischemic Stroke

Treatments

Drug: HT-3951

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02530307

HT-3951-201

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main 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 1.
Mild to moderate unilateral upper extremity motor impairment characterized by FMA-EU score of > 18
Modified Rankin Scale score of 1 to 4

Main 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)