HT-3951 vs. Placebo in Stroke Rehabilitation

Phase 2

Terminated

• Conditions: Ischemic Stroke
• Interventions: Drug: Placebo; Drug: HT-3951

• Registration Number: NCT02530307
• Lead Sponsor: Dart NeuroScience, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Study Start: 2016-02
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules administered once daily
HT-3951 (15mg)	HT-3951	HT-3951 capsules administered once daily

Primary Outcome Measures

Name	Time	Method
Hand Grip Strength Dynamometer Test	21-days
Nine-Hole Peg Test	21-days
Fugl-Meyer Assessment of Upper Extremity, Part A-D	21-days
Stroke Impact Scale (hand domain)	21-days
Arm Motor Ability Test-9	21-days
Index Finger-Tapping Frequency Test	21-days
Somatosensory evoked potential (if available)	21-days

Secondary Outcome Measures

Name	Time	Method
Two-Minute Walk Test	21-days
Behavioral, neural activity and motor network connectivity levels, using functional MRI	21-days