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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT00272909
• Date of registration: 05/01/2006
• Prospective Registration: No
• Primary sponsor: Daiichi Sankyo Inc.
• Public title: Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)
• Scientific title: 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
• Date of first enrolment: September 2004
• Target sample size: 43
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00272909
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Germany, Israel, Poland, South Africa, Spain, United States

Key inclusion & exclusion 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.)



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Drug: piclozotan low dose

Drug: piclozotan high dose

Drug: placebo

Primary Outcome(s)

Improvement in MRI [Time Frame: 28 days]

Secondary Outcome(s)

To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke. [Time Frame: Days 28, 60 and 90]

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]

Secondary ID(s)

SPI-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors