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

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Piclozotan

Criteria

Inclusion Criteria:

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.)

Exclusion Criteria:

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.)