Trial record 3 of 7 for:    ASUBIO

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

This study has been terminated.
Sponsor:
Information provided by:
Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00272909
First received: January 5, 2006
Last updated: April 4, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Stroke
Drug: piclozotan low dose
Drug: placebo
Drug: piclozotan high dose
Phase 2

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
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

Resource links provided by NLM:


Further study details as provided by Asubio Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Improvement in MRI [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in stroke lesion volume from Screening to day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke. [ Time Frame: Days 28, 60 and 90 ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2004
Study Completion Date: January 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272909

  Show 47 Study Locations
Sponsors and Collaborators
Asubio Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Ron Corey, PhD, MBA Executive Director, Clinical and Project Management, Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00272909     History of Changes
Other Study ID Numbers: SPI-103
Study First Received: January 5, 2006
Last Updated: April 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:
Acute Ischemic Stroke
9-Hour window MRI
Serotonin receptor agonist

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014