HT-3951 vs. Placebo in Stroke Rehabilitation

NCT ID: NCT02530307

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-12-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HT-3951 (15mg)

HT-3951 capsules administered once daily

Group Type: EXPERIMENTAL

HT-3951

Intervention Type: DRUG

Placebo

Placebo capsules administered once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

HT-3951

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dart NeuroScience, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Perera, MD

Role: STUDY_DIRECTOR

Dart NeuroScience, LLC

Locations

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Downey, California, United States

Glendale, California, United States

Loma Linda, California, United States

Orlando, Florida, United States

Chicago, Illinois, United States

Grand Rapids, Michigan, United States

Kansas City, Missouri, United States

West Orange, New Jersey, United States

New York, New York, United States

White Plains, New York, United States

Charlotte, North Carolina, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Elkins Park, Pennsylvania, United States

Dallas, Texas, United States

Houston, Texas, United States

Countries

United States

Other Identifiers

HT-3951-201

Identifier Type: -

Identifier Source: org_study_id