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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272909
Recruitment Status : Terminated
First Posted : January 9, 2006
Last Update Posted : October 20, 2015
Information provided by:
Daiichi Sankyo, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Drug: piclozotan low dose Drug: placebo Drug: piclozotan high dose Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : January 2007

Arm Intervention/treatment
Experimental: 1
piclozotan IV infusion, low dose, for 72 hours.
Drug: piclozotan low dose
Continuous IV infusion over a period of up to 72 hours of piclozotan

Experimental: 2
piclozotan IV infusion, high dose, for 72 hours.
Drug: piclozotan high dose
Continuous IV infusion over a period of up to 72 hours of piclozotan

Placebo Comparator: 3
placebo (normal saline) IV infusion, for 72 hours.
Drug: placebo
Continuous IV infusion over a period of up to 72 hours of placebo.

Primary Outcome Measures :
  1. Improvement in MRI [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. The change in stroke lesion volume from Screening to day 28 [ Time Frame: 28 days ]
  2. 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 ]
  3. To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke. [ Time Frame: Days 28, 60 and 90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00272909

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Sponsors and Collaborators
Daiichi Sankyo, Inc.
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Responsible Party: Ron Corey, PhD, MBA Executive Director, Clinical and Project Management, Asubio Pharmaceuticals, Inc. Identifier: NCT00272909    
Other Study ID Numbers: SPI-103
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by Daiichi Sankyo, Inc.:
Acute Ischemic Stroke
9-Hour window MRI
Serotonin receptor agonist
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs