Study Stopped
Administrative
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
1 other identifier
interventional
61
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2016
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
August 21, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFebruary 1, 2018
January 1, 2018
1.9 years
August 6, 2015
January 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (2)
Two-Minute Walk Test
21-days
Behavioral, neural activity and motor network connectivity levels, using functional MRI
21-days
Study Arms (2)
HT-3951 (15mg)
EXPERIMENTALHT-3951 capsules administered once daily
Placebo
PLACEBO COMPARATORPlacebo capsules administered once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Downey, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Loma Linda, California, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
West Orange, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
White Plains, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Elkins Park, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philip Perera, MD
Dart NeuroScience, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2015
First Posted
August 21, 2015
Study Start
February 1, 2016
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
February 1, 2018
Record last verified: 2018-01