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

NCT00272909 | Terminated Phase 2 DMC

• 1 other identifier: SPI-103
• Study Type: interventional
• Target: 43
• Locations: 7 countries
• Sites: 47

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.

Conditions

Stroke

Keywords

Acute Ischemic Stroke; 9-Hour window MRI; Serotonin receptor agonist

Outcome Measures

Primary Outcomes (1)

• Improvement in MRI

  28 days

Secondary Outcomes (3)

• The change in stroke lesion volume from Screening to day 28

  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]).

  Days 28 and 90

• To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke.

  Days 28, 60 and 90

Study Arms (3)

1

EXPERIMENTAL

piclozotan IV infusion, low dose, for 72 hours.

Drug: piclozotan low dose

2

EXPERIMENTAL

piclozotan IV infusion, high dose, for 72 hours.

Drug: piclozotan high dose

3

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

piclozotan low dose DRUG

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

1

placebo DRUG

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

3

piclozotan high dose DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (47)

UCLA Stroke Network

Los Angeles, California, 90024, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

The Stroke Center at Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

OCALA Neurodiagnostic Center

Ocala, Florida, 34471, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Ruan Neurology Clinic and Clinical Research Center

Des Moines, Iowa, 50314, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

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

Lexington, Kentucky, 40536, United States

Location

University of Massachusetts, Memorial Health Center, Department of Neurology

Worcester, Massachusetts, 01655, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Michigan State University, Sparrow Health System

East Lansing, Michigan, 48824, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Advance Neurology Specialists

Great Falls, Montana, 59405, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

SUNY at Stony Brook, University Hospital at Stony Brook

Stony Brook, New York, 11794, United States

Location

Moses Cone Hospital

Greensboro, North Carolina, 27401, United States

Location

Clinical Research Center of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Summa Health System Neurology and Neuroscience Associates

Akron, Ohio, 44309, United States

Location

Chattanooga Neurology Associates

Chattanooga, Tennessee, 37404, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

The Methodist Hospital Neurological Institute

Houston, Texas, 77030, United States

Location

INOVA Research Center

Falls Church, Virginia, 22042, United States

Location

Charleston Area Medical Center Health Education and Research Institute

Charleston, West Virginia, 25304, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

General Hospital Middelheim, Dept. of Neurology

Antwerp, 2020, Belgium

Location

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

Brussels, B-1070, Belgium

Location

Uz Gasthuisberg, Neurology

Leuven, 3000, Belgium

Location

Universitatsklinikum Essen, Department of Neurology

Essen, D-45147, Germany

Location

Neurologische Universitatsklinik und Poliklinik - Neurzentrum

Freiburg im Breisgau, 79106, Germany

Location

Universitatsklinikum Leipzig Aor, Klinik And Poliklinok Fur Neurologie

Leipzig, 04103, Germany

Location

Neurologische Klinik, Klinikum Rechts Der Isar Der Tu Munchen

München, 81675, Germany

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Assaf Harofeh Medical Center

Zrifin, 70300, Israel

Location

Centralny Szpital Kliniczny

Katowice, 40-752, Poland

Location

Collegium Medicum Jegiellonian University

Krakow, 31-503, Poland

Location

Military Institute of Medicine

Warsaw, 00-909, Poland

Location

St Augustines Hospital

Durban, 4001, South Africa

Location

Vergelegen Medi-Clinic

Somerset West, 7130, South Africa

Location

Sunninghill Hospital Cnr.

Sunninghill, 2157, South Africa

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Location

University Hospital of Girona Dr. Josep Trueta, Neurology Department

Girona, 17007, Spain

Location

Hospitales Universitarios Virgen Del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Piclozotan

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: September 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: January 1, 2007
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

IL (6); PL (3); ZA (3); ES (3); DE (4); BE (3); US (25)