Study Stopped
Administrative
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
1 other identifier
interventional
1
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2017
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedStudy Start
First participant enrolled
November 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFebruary 1, 2018
January 1, 2018
2 months
August 14, 2017
January 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (9)
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
- +4 more secondary outcomes
Other Outcomes (1)
fMRI Imaging
84-days
Study Arms (3)
DNS-3379 (0.5mg)
EXPERIMENTALDNS-3379 (2.5mg)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Repatriation General Hospital
Daw Park, South Australia, Australia
Lyell McEwin
Elizabeth Vale, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
St Vincents Melbourne
Fitzroy, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Western Health
St Albans, Victoria, Australia
Albury/Wodonga Hospital
Wodonga, Victoria, Australia
Hollywood Hospital
Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Auckland Hospital
Auckland, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 18, 2017
Study Start
November 13, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
February 1, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share