HT-3951 vs. Placebo in Stroke Rehabilitation "RESTORE"

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo capsules administered once daily
  • HT-3951 Drug
    ARM 1: Kind: Experimental
    Label: HT-3951 (15mg)
    Description: HT-3951 capsules administered once daily

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment of Upper Extremity, Part A-D 21-days No
Primary Index Finger-Tapping Frequency Test 21-days No
Primary Nine-Hole Peg Test 21-days No
Primary Hand Grip Strength Dynamometer Test 21-days No
Primary Arm Motor Ability Test-9 21-days No
Primary Stroke Impact Scale (hand domain) 21-days No
Primary Somatosensory evoked potential (if available) 21-days No
Secondary Two-Minute Walk Test 21-days No
Secondary Behavioral, neural activity and motor network connectivity levels, using functional MRI 21-days No

Sponsors