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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Placebo; Drug: HT-3951

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
    • Scottsdale, Arizona, United States
  • California
    • Downey, California, United States
    • Glendale, California, United States
    • Loma Linda, California, United States
  • Florida
    • Orlando, Florida, United States
  • Illinois
    • Chicago, Illinois, United States
  • Michigan
    • Grand Rapids, Michigan, United States
  • Missouri
    • Kansas City, Missouri, United States
  • New Jersey
    • West Orange, New Jersey, United States
  • New York
    • New York, New York, United States
    • White Plains, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
  • Oklahoma
    • Tulsa, Oklahoma, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States
  • Texas
    • Dallas, Texas, United States
    • Houston, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HT-3951 (15mg); HT-3951 capsules administered once daily	Drug: HT-3951
PLACEBO_COMPARATOR: Placebo; Placebo capsules administered once daily	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dart NeuroScience, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (ESTIMATE): August 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Ischemic; fMRI; Stroke,
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: HT-3951-201