Ischemic StrokePhase 2SPIRITNCT03254160
DNS-3379 vs. Placebo in Stroke Rehabilitation
A Phase 2 study testing DNS-3379 in people with Ischemic Stroke, run by Dart NeuroScience, LLC at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- DNS-3379
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 13 Nov 2017to 31 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Australia15 sites
Royal Adelaide Hospital
Adelaide, South Australia
Sunshine Coast University Hospital
Birtinya, Queensland
Box Hill Hospital
Box Hill, Victoria
Repatriation General Hospital
Daw Park, South Australia
Lyell McEwin
Elizabeth Vale, South Australia
St Vincents Melbourne
Fitzroy, Victoria
Austin Hospital
Heidelberg, Victoria
The Alfred
Melbourne, Victoria
Hollywood Hospital
Nedlands, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia
John Hunter Hospital
New Lambton Heights, New South Wales
Royal Melbourne Hospital
Parkville, Victoria
Western Health
St Albans, Victoria
Royal North Shore Hospital
St Leonards, New South Wales
Albury/Wodonga Hospital
Wodonga, Victoria
About this study
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
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.
- Conditions
- Ischemic Stroke
- Being tested
- DNS-3379, Placebo
- Keywords
- Stroke, Rehabilitation, Ischemic
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNS-3379Drug
DNS-3379
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DNS-3379 (0.5mg) | Experimental | Not described Receives: Drug: DNS-3379 |
| DNS-3379 (2.5mg) | Experimental | Not described Receives: Drug: DNS-3379 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D
Measured: 42-days
Type and incidence of treatment emergent adverse events
Measured: 84-days
Safety Laboratory Assessments
Measured: 84-days
Vital signs and 12-lead ECG
Measured: 84-days
Secondary outcomes (9)
Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)
Measured: 84-days
Nine-Hole Peg Test
Measured: 84-days
Action Research Arm Test
Measured: 84-days
Stroke Impact Scale
Measured: 84-days
Modified Rankin Scale
Measured: 84-days
Change in weight
Measured: 84-days
Columbia Suicide Severity Rating Scale
Measured: 84-days
Two-Minute Walk Test
Measured: 84-days
EQ-5D-5L
Measured: 84-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start13 Nov 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dart NeuroScience, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254160
- Sponsor's protocol ID
- DNS-3379-201
- Acronym
- SPIRIT
- Status last verified
- Jan 2018
- First submitted
- 14 Aug 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03254160
- Acronym / sponsor ID
- SPIRIT / DNS-3379-201
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Rehabilitation, Ischemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dart NeuroScience, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DNS-3379 (0.5mg) | Experimental | Drug: DNS-3379 |
| DNS-3379 (2.5mg) | Experimental | Drug: DNS-3379 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNS-3379DNS-3379 | Drug | DNS-3379 (0.5mg), DNS-3379 (2.5mg) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D
Time frame: 42-days
Type and incidence of treatment emergent adverse events
Time frame: 84-days
Safety Laboratory Assessments
Time frame: 84-days
Vital signs and 12-lead ECG
Time frame: 84-days
9 secondary outcomes
Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)
Time frame: 84-days
Nine-Hole Peg Test
Time frame: 84-days
Action Research Arm Test
Time frame: 84-days
Stroke Impact Scale
Time frame: 84-days
Modified Rankin Scale
Time frame: 84-days
Change in weight
Time frame: 84-days
Columbia Suicide Severity Rating Scale
Time frame: 84-days
Two-Minute Walk Test
Time frame: 84-days
EQ-5D-5L
Time frame: 84-days
Results and safety
The study was stopped early (reason given: Administrative). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DNS-3379 in people with Ischemic Stroke, run by Dart NeuroScience, LLC at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administrative). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D (time frame: 42-days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.