This research study is designed to evaluate the safety, tolerability, and efficacy of SUN N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of symptoms.
The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 (piclozotan) in subjects with clinical findings of an acute ischemic stroke and a magnetic resonance imaging (MRI) demonstrating a measurable penumbra (perfusion-weighted imaging \[PWI\] minus diffusion-weighted imaging \[DWI\] volume). Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume as assessed by DWI at Screening to stroke lesion volume assessed by FLAIR (fluid-attenuated inversion recovery) on Day 28 in the piclozotan group versus the placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Continuous IV infusion over a period of up to 72 hours of piclozotan
Continuous IV infusion over a period of up to 72 hours of placebo.
Continuous IV infusion over a period of up to 72 hours of piclozotan
Improvement in MRI
Time frame: 28 days
The change in stroke lesion volume from Screening to day 28
Time frame: 28 days
Clinical outcomes at Days 28 and 90 using the individual clinical scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale [NIHSS]).
Time frame: Days 28 and 90
To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke.
Time frame: Days 28, 60 and 90
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UCLA Stroke Network
Los Angeles, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
The Stroke Center at Hartford Hospital
Hartford, Connecticut, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
OCALA Neurodiagnostic Center
Ocala, Florida, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Ruan Neurology Clinic and Clinical Research Center
Des Moines, Iowa, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
University of Kentucky, Sanders Brown Center on Aging/Stroke Program
Lexington, Kentucky, United States
University of Massachusetts, Memorial Health Center, Department of Neurology
Worcester, Massachusetts, United States
...and 37 more locations