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

Primary Purpose

Ischemic Stroke

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DNS-3379
Placebo
Sponsored by
Dart NeuroScience, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke, Rehabilitation, Ischemic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Hunter Hospital
  • Royal North Shore Hospital
  • Sunshine Coast University Hospital
  • Royal Adelaide Hospital
  • Repatriation General Hospital
  • Lyell McEwin
  • Box Hill Hospital
  • St Vincents Melbourne
  • Austin Hospital
  • The Alfred
  • Royal Melbourne Hospital
  • Western Health
  • Albury/Wodonga Hospital
  • Hollywood Hospital
  • Sir Charles Gairdner Hospital
  • Auckland Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DNS-3379 (0.5mg)

DNS-3379 (2.5mg)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2017
Last Updated
January 30, 2018
Sponsor
Dart NeuroScience, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03254160
Brief Title
DNS-3379 vs. Placebo in Stroke Rehabilitation
Acronym
SPIRIT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Administrative
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dart NeuroScience, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Stroke, Rehabilitation, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DNS-3379 (0.5mg)
Arm Type
Experimental
Arm Title
DNS-3379 (2.5mg)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DNS-3379
Intervention Description
DNS-3379
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D
Time Frame
42-days
Title
Type and incidence of treatment emergent adverse events
Time Frame
84-days
Title
Safety Laboratory Assessments
Time Frame
84-days
Title
Vital signs and 12-lead ECG
Time Frame
84-days
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)
Time Frame
84-days
Title
Nine-Hole Peg Test
Time Frame
84-days
Title
Action Research Arm Test
Time Frame
84-days
Title
Stroke Impact Scale
Time Frame
84-days
Title
Modified Rankin Scale
Time Frame
84-days
Title
Change in weight
Time Frame
84-days
Title
Columbia Suicide Severity Rating Scale
Time Frame
84-days
Title
Two-Minute Walk Test
Time Frame
84-days
Title
EQ-5D-5L
Time Frame
84-days
Other Pre-specified Outcome Measures:
Title
fMRI Imaging
Time Frame
84-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Repatriation General Hospital
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
Lyell McEwin
City
Elizabeth Vale
State/Province
South Australia
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
St Vincents Melbourne
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
Western Health
City
St Albans
State/Province
Victoria
Country
Australia
Facility Name
Albury/Wodonga Hospital
City
Wodonga
State/Province
Victoria
Country
Australia
Facility Name
Hollywood Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Auckland Hospital
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

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DNS-3379 vs. Placebo in Stroke Rehabilitation

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