A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of SUN N4057 (Piclozotan)Administered for 72 Hours by Continuous Intravenous Infusion in Subjects with Acute Ischemic Stroke and Measurable Penumbra on MRI.

Daiichi Asubio Pharmaceuticals Inc.0 sites206 target enrollmentMay 19, 2005

Overview

No summary available.

Registry

who.int

Start Date

May 19, 2005

End Date

October 24, 2006

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Daiichi Asubio Pharmaceuticals Inc.

•General Inclusion Criteria
•1\.Males or females \>\= 18 and \<\= 85 years of age at randomization. Female subjects must be either:
•\- Surgically sterile
•\- Post\-menopausal for at least 1 year
•\- Non pregnant confirmed by serum pregnancy test, and using a method
•of birth control that is acceptable to the investigator.
•2\.Neurological examination demonstrating localizing cortical signs
•3\.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)
•4\.Signed informed consent from subject or a legally acceptable representative
•5\.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

•General Exclusion Criteria:
•1\.Two or more of the following:
•a.Reduced level of consciousness (score ? 2 on NIHSS Q1a)
•b.Forced eye deviation or total gaze paresis (score of 2 on NIHSS Q2\)
•c.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)
•2\.Pre\-stroke Modified Rankin score ? 2 at Screening
•3\.Rapid neurological improvement from Screening up to the start of drug infusion
•4\.Persistent systolic blood pressure (SBP) \> 220 mmHg and/or diastolic blood pressure (DSP) \> 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, the subject may be enrolled.
•5\.Aggressive anti\-hypertensive therapy required to maintain blood pressure at acceptable levels
•6\.Female subjects who are pregnant and/or nursing, confirmed by serum pregnancy test