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

NCT ID: NCT00272909

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-01-31

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

piclozotan IV infusion, low dose, for 72 hours.

Group Type: EXPERIMENTAL

piclozotan low dose

Intervention Type: DRUG

Continuous IV infusion over a period of up to 72 hours of piclozotan

2

piclozotan IV infusion, high dose, for 72 hours.

Group Type: EXPERIMENTAL

piclozotan high dose

Intervention Type: DRUG

Continuous IV infusion over a period of up to 72 hours of piclozotan

3

placebo (normal saline) IV infusion, for 72 hours.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Continuous IV infusion over a period of up to 72 hours of placebo.

Interventions

piclozotan low dose

Continuous IV infusion over a period of up to 72 hours of piclozotan

Intervention Type: DRUG

placebo

Continuous IV infusion over a period of up to 72 hours of placebo.

Intervention Type: DRUG

piclozotan high dose

Continuous IV infusion over a period of up to 72 hours of piclozotan

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• 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.

• Intracranial hemorrhage as verified by Screening MRI. (Note: intracranial hemorrhage on pre-screen computerized tomography [CT] scan also excludes subject.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Asubio Pharmaceuticals, Inc.

Locations

UCLA Stroke Network

Los Angeles, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

The Stroke Center at Hartford Hospital

Hartford, Connecticut, United States

Lakeland Regional Medical Center

Lakeland, Florida, United States

OCALA Neurodiagnostic Center

Ocala, Florida, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Ruan Neurology Clinic and Clinical Research Center

Des Moines, Iowa, United States

Via Christi Regional Medical Center

Wichita, Kansas, United States

University of Kentucky, Sanders Brown Center on Aging/Stroke Program

Lexington, Kentucky, United States

University of Massachusetts, Memorial Health Center, Department of Neurology

Worcester, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Michigan State University, Sparrow Health System

East Lansing, Michigan, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Advance Neurology Specialists

Great Falls, Montana, United States

St. Francis Medical Center

Trenton, New Jersey, United States

SUNY at Stony Brook, University Hospital at Stony Brook

Stony Brook, New York, United States

Moses Cone Hospital

Greensboro, North Carolina, United States

Clinical Research Center of Winston-Salem

Winston-Salem, North Carolina, United States

Summa Health System Neurology and Neuroscience Associates

Akron, Ohio, United States

Chattanooga Neurology Associates

Chattanooga, Tennessee, United States

Methodist University Hospital

Memphis, Tennessee, United States

The Methodist Hospital Neurological Institute

Houston, Texas, United States

INOVA Research Center

Falls Church, Virginia, United States

Charleston Area Medical Center Health Education and Research Institute

Charleston, West Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

General Hospital Middelheim, Dept. of Neurology

Antwerp, , Belgium

Hopital Erasme - Dept. of Neurology, Universite Libre de Bruxelles

Brussels, , Belgium

Uz Gasthuisberg, Neurology

Leuven, , Belgium

Universitatsklinikum Essen, Department of Neurology

Essen, , Germany

Neurologische Universitatsklinik und Poliklinik - Neurzentrum

Freiburg im Breisgau, , Germany

Universitatsklinikum Leipzig Aor, Klinik And Poliklinok Fur Neurologie

Leipzig, , Germany

Neurologische Klinik, Klinikum Rechts Der Isar Der Tu Munchen

München, , Germany

Soroka University Medical Center

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Hadassah University Hospital

Jerusalem, , Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Assaf Harofeh Medical Center

Zrifin, , Israel

Centralny Szpital Kliniczny

Katowice, , Poland

Collegium Medicum Jegiellonian University

Krakow, , Poland

Military Institute of Medicine

Warsaw, , Poland

St Augustines Hospital

Durban, , South Africa

Vergelegen Medi-Clinic

Somerset West, , South Africa

Sunninghill Hospital Cnr.

Sunninghill, , South Africa

Hospital Universitari Germans Trias i Pujol

Barcelona, , Spain

University Hospital of Girona Dr. Josep Trueta, Neurology Department

Girona, , Spain

Hospitales Universitarios Virgen Del Rocio

Seville, , Spain

Countries

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

Other Identifiers

SPI-103

Identifier Type: -

Identifier Source: org_study_id