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

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ClinicalTrials.gov Identifier: NCT02530307
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: HT-3951 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Fugl-Meyer Assessment of Upper Extremity, Part A-D [ Time Frame: 21-days ]
  2. Index Finger-Tapping Frequency Test [ Time Frame: 21-days ]
  3. Nine-Hole Peg Test [ Time Frame: 21-days ]
  4. Hand Grip Strength Dynamometer Test [ Time Frame: 21-days ]
  5. Arm Motor Ability Test-9 [ Time Frame: 21-days ]
  6. Stroke Impact Scale (hand domain) [ Time Frame: 21-days ]
  7. Somatosensory evoked potential (if available) [ Time Frame: 21-days ]

Secondary Outcome Measures :
  1. Two-Minute Walk Test [ Time Frame: 21-days ]
  2. Behavioral, neural activity and motor network connectivity levels, using functional MRI [ Time Frame: 21-days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530307


Contacts
Contact: Dart NeuroScience, LLC 858-246-8144 clinicaltrials@dartneuroscience.com

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States
Recruiting
Scottsdale, Arizona, United States
United States, California
Recruiting
Downey, California, United States
Recruiting
Glendale, California, United States
Recruiting
Loma Linda, California, United States
United States, Florida
Recruiting
Orlando, Florida, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Michigan
Recruiting
Grand Rapids, Michigan, United States
United States, Missouri
Recruiting
Kansas City, Missouri, United States
United States, New Jersey
Recruiting
West Orange, New Jersey, United States
United States, New York
Recruiting
New York, New York, United States
Recruiting
White Plains, New York, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Elkins Park, Pennsylvania, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Recruiting
Houston, Texas, United States
Sponsors and Collaborators
Dart NeuroScience, LLC
Investigators
Study Director: Philip Perera, MD Dart NeuroScience, LLC
More Information

Responsible Party: Dart NeuroScience, LLC
ClinicalTrials.gov Identifier: NCT02530307     History of Changes
Other Study ID Numbers: HT-3951-201
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Keywords provided by Dart NeuroScience, LLC:
Stroke,
Rehabilitation
Ischemic
fMRI

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes