DNS-3379 vs. Placebo in Stroke Rehabilitation (SPIRIT)

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 42-Day Treatment Study to Evaluate the Effect of DNS-3379 on Upper Extremity Motor Function Following Ischemic Stroke

This is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate the effect of DNS-3379 on upper extremity motor recovery in subjects following ischemic stroke.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Placebo; Drug: DNS-3379

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia
      • John Hunter Hospital
    • St Leonards, New South Wales, Australia
      • Royal North Shore Hospital
  • Queensland
    • Birtinya, Queensland, Australia
      • Sunshine Coast University Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Royal Adelaide Hospital
    • Daw Park, South Australia, Australia
      • Repatriation General Hospital
    • Elizabeth Vale, South Australia, Australia
      • Lyell McEwin
  • Victoria
    • Box Hill, Victoria, Australia
      • Box Hill Hospital
    • Fitzroy, Victoria, Australia
      • St Vincents Melbourne
    • Heidelberg, Victoria, Australia
      • Austin Hospital
    • Melbourne, Victoria, Australia
      • The Alfred
    • Parkville, Victoria, Australia
      • Royal Melbourne Hospital
    • St Albans, Victoria, Australia
      • Western Health
    • Wodonga, Victoria, Australia
      • Albury/Wodonga Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia
      • Sir Charles Gairdner Hospital
    • Nedlands, Western Australia, Australia
      • Hollywood Hospital
• New Zealand
  • Auckland, New Zealand
    • Auckland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in upper extremity deficit that warrants the need for rehabilitation therapy.
• Medically stable subjects, with expected survival > 12 months, who are able to be randomized to study drug beginning between 1 and 52 weeks (i.e., 7 to 365 days) post-stroke.
• Mild to moderately severe upper extremity motor impairment.
• mRS score of 1 to 4 from index stroke.
• Mini Mental State Examination (MMSE) score of ≥ 22.

Main Exclusion Criteria:

• Residual motor deficit from any prior stroke
• Hemorrhagic stroke. Ischemic stroke with limited hemorrhagic conversion (i.e., petechial hemorrhage or micro-hemorrhage) is acceptable.
• Severe or total sensory loss
• Moderate to severe aphasia and/or severe language deficits
• Excessive spasticity in the affected elbow or change in oral spasticity treatment drugs within 2 weeks before the Screening Visit
• Prior botulinum toxin injection to any portion of the affected arm in the prior 3 months before the Screening Visit
• Major and active neurological, psychiatric, or medical diagnosis that is not adequately controlled and would likely reduce the safety of study participation or impact the subject's ability to comply with study protocol procedures in the opinion of the Investigator
• Any suicidal ideation during the subject's lifetime at any time prior to randomization including childhood (based on subject history), equivalent to type 2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Received an investigational pharmacotherapy therapy within the past 3 months
• Heavy use of any tobacco-smoke emitting products (including but not limited to cigarettes, pipes, and cigars) within 30 days of Baseline.
• Pregnant or lactating females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo
EXPERIMENTAL: DNS-3379 (0.5mg)	Drug: DNS-3379; DNS-3379
EXPERIMENTAL: DNS-3379 (2.5mg)	Drug: DNS-3379; DNS-3379

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D	42-days
Type and incidence of treatment emergent adverse events	84-days
Safety Laboratory Assessments	84-days
Vital signs and 12-lead ECG	84-days

Secondary Outcome Measures

Outcome Measure	Time Frame
Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)	84-days
Nine-Hole Peg Test	84-days
Action Research Arm Test	84-days
Stroke Impact Scale	84-days
Modified Rankin Scale	84-days
Change in weight	84-days
Columbia Suicide Severity Rating Scale	84-days
Two-Minute Walk Test	84-days
EQ-5D-5L	84-days

Other Outcome Measures

Outcome Measure	Time Frame
fMRI Imaging	84-days

Collaborators and Investigators

• Sponsor: Dart NeuroScience, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2017
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (ACTUAL): August 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Ischemic
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: DNS-3379-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No