Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00272909

Run by

Daiichi Sankyo

People needed

43

Starts

2004-09-01

Expected to finish

2007-01-01

Last updated by the study team

2015-10-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General inclusion criteria:
• Males or females >= 18 and <= 85 years of age at randomization. Female subjects must be either:
• Surgically sterile;
• Postmenopausal for at least 1 year; or
• Non-pregnant, confirmed by a serum pregnancy test, and using a method of birth control that is acceptable to the investigator.
• Neurological examination demonstrating localizing cortical signs
• Receipt of study drug less than 6 hours (50% of subjects) or between 6 and 9 hours, inclusive, (50% of subjects) after the onset of symptoms (for un-witnessed stroke, last time seen in normal state or at bedtime for un-witnessed stroke during sleep)
• Signed informed consent from subject or legally acceptable representative
• NIHSS score of 6 - 22, inclusive, or at least 2 on the aphasia item of the NIHSS with a location of MRI findings consistent with aphasia
• MRI-determined inclusion criteria:
• Acute ischemic stroke with substantial cortical involvement in the middle cerebral artery (MCA) distribution, as verified by the Screening DWI abnormality and/or Screening PWI abnormality. (Note: white matter involvement, in addition to cortex, is not an exclusion.)

You may not qualify if…

• General exclusion criteria:
• Two or more of the following:
• Reduced level of consciousness (score >= 2 on NIHSS Q1a)
• Forced eye deviation or total gaze paresis (score of 2 on NIHSS Q2)
• Dense hemiplegia (no movement) of upper and lower extremities (score of 4 on NIHSS Q5 regarding motor arm and a score of 4 on NIHSS Q6 regarding motor leg)
• Pre-stroke modified Rankin score >= 2 at Screening
• Rapid neurological improvement from Screening up to the start of drug infusion
• Persistent systolic blood pressure (SBP) > 220 mmHg and/or diastolic blood pressure (DBP) > 120 mmHg (confirmed by at least three readings taken at least 3 minutes apart) prior to randomization. If subsequent readings are consistently below these levels, either spontaneously or following mild antihypertensive therapy, subject may be enrolled.
• MRI-determined exclusion criteria:
• Intracranial hemorrhage as verified by Screening MRI. (Note: intracranial hemorrhage on pre-screen computerized tomography [CT] scan also excludes subject.)

Where it is running

• 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
• Wayne State University — Detroit, Michigan, United States
• Michigan State University, Sparrow Health System — East Lansing, Michigan, United States
• St. Luke's Hospital — Kansas City, Missouri, United States
• Advance Neurology Specialists — Great Falls, Montana, United States
• St. Francis Medical Center — Trenton, New Jersey, United States
• SUNY at Stony Brook, University Hospital at Stony Brook — Stony Brook, New York, United States
• Moses Cone Hospital — Greensboro, North Carolina, United States
• Clinical Research Center of Winston-Salem — Winston-Salem, North Carolina, United States
• Summa Health System Neurology and Neuroscience Associates — Akron, Ohio, United States
• Chattanooga Neurology Associates — Chattanooga, Tennessee, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• The Methodist Hospital Neurological Institute — Houston, Texas, United States
• INOVA Research Center — Falls Church, Virginia, United States
• Charleston Area Medical Center Health Education and Research Institute — Charleston, West Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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