HT-3951 vs. Placebo in Stroke Rehabilitation (RESTORE)
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ClinicalTrials.gov Identifier: NCT02530307 |
Recruitment Status :
Terminated
(Administrative)
First Posted : August 21, 2015
Last Update Posted : February 1, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ischemic Stroke | Drug: HT-3951 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 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 |
Actual Primary Completion Date : | December 31, 2017 |
Actual Study Completion Date : | December 31, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: HT-3951 (15mg)
HT-3951 capsules administered once daily
|
Drug: HT-3951 |
Placebo Comparator: Placebo
Placebo capsules administered once daily
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Drug: Placebo |
- Fugl-Meyer Assessment of Upper Extremity, Part A-D [ Time Frame: 21-days ]
- Index Finger-Tapping Frequency Test [ Time Frame: 21-days ]
- Nine-Hole Peg Test [ Time Frame: 21-days ]
- Hand Grip Strength Dynamometer Test [ Time Frame: 21-days ]
- Arm Motor Ability Test-9 [ Time Frame: 21-days ]
- Stroke Impact Scale (hand domain) [ Time Frame: 21-days ]
- Somatosensory evoked potential (if available) [ Time Frame: 21-days ]
- Two-Minute Walk Test [ Time Frame: 21-days ]
- Behavioral, neural activity and motor network connectivity levels, using functional MRI [ Time Frame: 21-days ]

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Ages Eligible for Study: | 21 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
United States, Arizona | |
Phoenix, Arizona, United States | |
Scottsdale, Arizona, United States | |
United States, California | |
Downey, California, United States | |
Glendale, California, United States | |
Loma Linda, California, United States | |
United States, Florida | |
Orlando, Florida, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Michigan | |
Grand Rapids, Michigan, United States | |
United States, Missouri | |
Kansas City, Missouri, United States | |
United States, New Jersey | |
West Orange, New Jersey, United States | |
United States, New York | |
New York, New York, United States | |
White Plains, New York, United States | |
United States, North Carolina | |
Charlotte, North Carolina, United States | |
United States, Oklahoma | |
Tulsa, Oklahoma, United States | |
United States, Oregon | |
Portland, Oregon, United States | |
United States, Pennsylvania | |
Elkins Park, Pennsylvania, United States | |
United States, Texas | |
Dallas, Texas, United States | |
Houston, Texas, United States |
Study Director: | Philip Perera, MD | Dart NeuroScience, LLC |
Responsible Party: | Dart NeuroScience, LLC |
ClinicalTrials.gov Identifier: | NCT02530307 |
Other Study ID Numbers: |
HT-3951-201 |
First Posted: | August 21, 2015 Key Record Dates |
Last Update Posted: | February 1, 2018 |
Last Verified: | January 2018 |
Stroke, Rehabilitation Ischemic fMRI |
Stroke Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |