DNS-3379 vs. Placebo in Stroke Rehabilitation

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03254160
• Other study ID #: DNS-3379-201
• Status: Terminated
• Phase: Phase 2
• First received: August 14, 2017
• Last updated: January 30, 2018
• Start date: November 13, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Dart NeuroScience, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• DNS-3379
DNS-3379
• Placebo
Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dart NeuroScience, LLC

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fMRI Imaging		84-days
Primary	Fugl-Meyer Assessment of Upper Extremity Motor Function, Parts A-D		42-days
Primary	Type and incidence of treatment emergent adverse events		84-days
Primary	Safety Laboratory Assessments		84-days
Primary	Vital signs and 12-lead ECG		84-days
Secondary	Fugl-Meyer Assessment of Upper Extremity Motor Function (Parts A-D)		84-days
Secondary	Nine-Hole Peg Test		84-days
Secondary	Action Research Arm Test		84-days
Secondary	Stroke Impact Scale		84-days
Secondary	Modified Rankin Scale		84-days
Secondary	Change in weight		84-days
Secondary	Columbia Suicide Severity Rating Scale		84-days
Secondary	Two-Minute Walk Test		84-days
Secondary	EQ-5D-5L		84-days