HT-3951 vs. Placebo in Stroke Rehabilitation

Ischemic Stroke Clinical Trial

— RESTORE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02530307
• Other study ID #: HT-3951-201
• Status: Terminated
• Phase: Phase 2
• First received: August 6, 2015
• Last updated: January 30, 2018
• Start date: February 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Dart NeuroScience, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• HT-3951

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dart NeuroScience, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment of Upper Extremity, Part A-D		21-days
Primary	Index Finger-Tapping Frequency Test		21-days
Primary	Nine-Hole Peg Test		21-days
Primary	Hand Grip Strength Dynamometer Test		21-days
Primary	Arm Motor Ability Test-9		21-days
Primary	Stroke Impact Scale (hand domain)		21-days
Primary	Somatosensory evoked potential (if available)		21-days
Secondary	Two-Minute Walk Test		21-days
Secondary	Behavioral, neural activity and motor network connectivity levels, using functional MRI		21-days