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

October 19, 2015 updated by: Daiichi Sankyo, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • General Hospital Middelheim, Dept. of Neurology
      • Brussels, Belgium, B-1070
        • Hopital Erasme - Dept. of Neurology, Universite Libre de Bruxelles
      • Leuven, Belgium, 3000
        • Uz Gasthuisberg, Neurology
  • Germany
      • Essen, Germany, D-45147
        • Universitatsklinikum Essen, Department of Neurology
      • Freiburg, Germany, 79106
        • Neurologische Universitatsklinik und Poliklinik - Neurzentrum
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig Aor, Klinik And Poliklinok Fur Neurologie
      • Munchen, Germany, 81675
        • Neurologische Klinik, Klinikum Rechts Der Isar Der Tu Munchen
  • Israel
      • Beer-Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
      • Tel Hashomer, Israel, 52621
        • Chaim Sheba Medical Center
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
      • Zrifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Poland
      • Katowice, Poland, 40-752
        • Centralny Szpital Kliniczny
      • Krakow, Poland, 31-503
        • Collegium Medicum Jegiellonian University
      • Warsaw, Poland, 00-909
        • Military Institute of Medicine
  • South Africa
      • Durban, South Africa, 4001
        • St Augustines Hospital
      • Somerset West, South Africa, 7130
        • Vergelegen Medi-Clinic
      • Sunninghill, South Africa, 2157
        • Sunninghill Hospital Cnr.
  • Spain
      • Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias I Pujol
      • Girona, Spain, 17007
        • University Hospital of Girona Dr. Josep Trueta, Neurology Department
      • Sevilla, Spain, 41013
        • Hospitales Universitarios Virgen del Rocío
  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Stroke Network
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • The Stroke Center at Hartford Hospital
    • Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Medical Center
      • Ocala, Florida, United States, 34471
        • Ocala Neurodiagnostic Center
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Ruan Neurology Clinic and Clinical Research Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, Sanders Brown Center on Aging/Stroke Program
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts, Memorial Health Center, Department of Neurology
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • East Lansing, Michigan, United States, 48824
        • Michigan State University, Sparrow Health System
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
    • Montana
      • Great Falls, Montana, United States, 59405
        • Advance Neurology Specialists
    • New Jersey
      • Trenton, New Jersey, United States, 08629
        • St. Francis Medical Center
    • New York
      • Stony Brook, New York, United States, 11794
        • SUNY at Stony Brook, University Hospital at Stony Brook
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Moses Cone Hospital
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Research Center of Winston-Salem
    • Ohio
      • Akron, Ohio, United States, 44309
        • Summa Health System Neurology and Neuroscience Associates
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Neurology Associates
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Neurological Institute
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Research Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center Health Education and Research Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in MRI
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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