Clinical trial NCT02530307: HT-3951 vs. Placebo in Stroke Rehabilitation
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: Stroke,
Rehabilitation
Ischemic
fMRI
Lead sponsor: Dart NeuroScience, LLC
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 61
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity, Part A-D
timeFrame: 21-days
measure: Index Finger-Tapping Frequency Test
timeFrame: 21-days
measure: Nine-Hole Peg Test
timeFrame: 21-days
measure: Hand Grip Strength Dynamometer Test
timeFrame: 21-days
measure: Arm Motor Ability Test-9
timeFrame: 21-days
measure: Stroke Impact Scale (hand domain)
timeFrame: 21-days
measure: Somatosensory evoked potential (if available)
timeFrame: 21-days
Secondary outcomes:
measure: Two-Minute Walk Test
timeFrame: 21-days
measure: Behavioral, neural activity and motor network connectivity levels, using functional MRI
timeFrame: 21-days
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Downey
country: United States
state: California
city: Glendale
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Grand Rapids
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: West Orange
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: White Plains
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Elkins Park
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Dart NeuroScience, LLC
name: Philip Perera, MD
role: STUDY_DIRECTOR
References: