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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03254160




Registration number
NCT03254160
Ethics application status
Date submitted
14/08/2017
Date registered
18/08/2017

Titles & IDs
Public title
DNS-3379 vs. Placebo in Stroke Rehabilitation
Scientific 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
Secondary ID [1] 0 0
DNS-3379-201
Universal Trial Number (UTN)
Trial acronym
SPIRIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DNS-3379
Treatment: Drugs - Placebo

Experimental: DNS-3379 (0.5mg) -

Experimental: DNS-3379 (2.5mg) -

Placebo comparator: Placebo -


Treatment: Drugs: DNS-3379
DNS-3379

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D
Timepoint [1] 0 0
42-days
Primary outcome [2] 0 0
Type and incidence of treatment emergent adverse events
Timepoint [2] 0 0
84-days
Primary outcome [3] 0 0
Safety Laboratory Assessments
Timepoint [3] 0 0
84-days
Primary outcome [4] 0 0
Vital signs and 12-lead ECG
Timepoint [4] 0 0
84-days
Secondary outcome [1] 0 0
Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)
Timepoint [1] 0 0
84-days
Secondary outcome [2] 0 0
Nine-Hole Peg Test
Timepoint [2] 0 0
84-days
Secondary outcome [3] 0 0
Action Research Arm Test
Timepoint [3] 0 0
84-days
Secondary outcome [4] 0 0
Stroke Impact Scale
Timepoint [4] 0 0
84-days
Secondary outcome [5] 0 0
Modified Rankin Scale
Timepoint [5] 0 0
84-days
Secondary outcome [6] 0 0
Change in weight
Timepoint [6] 0 0
84-days
Secondary outcome [7] 0 0
Columbia Suicide Severity Rating Scale
Timepoint [7] 0 0
84-days
Secondary outcome [8] 0 0
Two-Minute Walk Test
Timepoint [8] 0 0
84-days
Secondary outcome [9] 0 0
EQ-5D-5L
Timepoint [9] 0 0
84-days

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Repatriation General Hospital - Daw Park
Recruitment hospital [6] 0 0
Lyell McEwin - Elizabeth Vale
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
St Vincents Melbourne - Fitzroy
Recruitment hospital [9] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [10] 0 0
The Alfred - Melbourne
Recruitment hospital [11] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [12] 0 0
Western Health - St Albans
Recruitment hospital [13] 0 0
Albury/Wodonga Hospital - Wodonga
Recruitment hospital [14] 0 0
Hollywood Hospital - Nedlands
Recruitment hospital [15] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- New Lambton Heights
Recruitment postcode(s) [2] 0 0
- St Leonards
Recruitment postcode(s) [3] 0 0
- Birtinya
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Daw Park
Recruitment postcode(s) [6] 0 0
- Elizabeth Vale
Recruitment postcode(s) [7] 0 0
- Box Hill
Recruitment postcode(s) [8] 0 0
- Fitzroy
Recruitment postcode(s) [9] 0 0
- Heidelberg
Recruitment postcode(s) [10] 0 0
- Melbourne
Recruitment postcode(s) [11] 0 0
- Parkville
Recruitment postcode(s) [12] 0 0
- St Albans
Recruitment postcode(s) [13] 0 0
- Wodonga
Recruitment postcode(s) [14] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dart NeuroScience, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03254160