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

Primary Purpose

Stroke

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
piclozotan low dose
placebo
piclozotan high dose
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute Ischemic Stroke, 9-Hour window MRI, Serotonin receptor agonist

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • UCLA Stroke Network
  • San Francisco Clinical Research Center
  • The Stroke Center at Hartford Hospital
  • Lakeland Regional Medical Center
  • OCALA Neurodiagnostic Center
  • Southern Illinois University School of Medicine
  • Ruan Neurology Clinic and Clinical Research Center
  • Via Christi Regional Medical Center
  • University of Kentucky, Sanders Brown Center on Aging/Stroke Program
  • University of Massachusetts, Memorial Health Center, Department of Neurology
  • Wayne State University
  • Michigan State University, Sparrow Health System
  • St. Luke's Hospital
  • Advance Neurology Specialists
  • St. Francis Medical Center
  • SUNY at Stony Brook, University Hospital at Stony Brook
  • Moses Cone Hospital
  • Clinical Research Center of Winston-Salem
  • Summa Health System Neurology and Neuroscience Associates
  • Chattanooga Neurology Associates
  • Methodist University Hospital
  • The Methodist Hospital Neurological Institute
  • INOVA Research Center
  • Charleston Area Medical Center Health Education and Research Institute
  • Medical College of Wisconsin
  • General Hospital Middelheim, Dept. of Neurology
  • Hopital Erasme - Dept. of Neurology, Universite Libre de Bruxelles
  • Uz Gasthuisberg, Neurology
  • Universitatsklinikum Essen, Department of Neurology
  • Neurologische Universitatsklinik und Poliklinik - Neurzentrum
  • Universitatsklinikum Leipzig Aor, Klinik And Poliklinok Fur Neurologie
  • Neurologische Klinik, Klinikum Rechts Der Isar Der Tu Munchen
  • Soroka University Medical Center
  • Rambam Medical Center
  • Hadassah University Hospital
  • Chaim Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • Centralny Szpital Kliniczny
  • Collegium Medicum Jegiellonian University
  • Military Institute of Medicine
  • St Augustines Hospital
  • Vergelegen Medi-Clinic
  • Sunninghill Hospital Cnr.
  • Hospital Universitari Germans Trias i Pujol
  • University Hospital of Girona Dr. Josep Trueta, Neurology Department
  • Hospitales Universitarios Virgen Del Rocio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

piclozotan IV infusion, low dose, for 72 hours.

piclozotan IV infusion, high dose, for 72 hours.

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

Outcomes

Primary Outcome Measures

Improvement in MRI

Secondary Outcome Measures

The change in stroke lesion volume from Screening to day 28
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]).
To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke.

Full Information

First Posted
January 5, 2006
Last Updated
October 19, 2015
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00272909
Brief Title
Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acute Ischemic Stroke, 9-Hour window MRI, Serotonin receptor agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
piclozotan IV infusion, low dose, for 72 hours.
Arm Title
2
Arm Type
Experimental
Arm Description
piclozotan IV infusion, high dose, for 72 hours.
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
placebo (normal saline) IV infusion, for 72 hours.
Intervention Type
Drug
Intervention Name(s)
piclozotan low dose
Intervention Description
Continuous IV infusion over a period of up to 72 hours of piclozotan
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Continuous IV infusion over a period of up to 72 hours of placebo.
Intervention Type
Drug
Intervention Name(s)
piclozotan high dose
Intervention Description
Continuous IV infusion over a period of up to 72 hours of piclozotan
Primary Outcome Measure Information:
Title
Improvement in MRI
Time Frame
28 days
Secondary Outcome Measure Information:
Title
The change in stroke lesion volume from Screening to day 28
Time Frame
28 days
Title
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
Title
To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke.
Time Frame
Days 28, 60 and 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
Facility Name
UCLA Stroke Network
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
The Stroke Center at Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
OCALA Neurodiagnostic Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Ruan Neurology Clinic and Clinical Research Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Kentucky, Sanders Brown Center on Aging/Stroke Program
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Massachusetts, Memorial Health Center, Department of Neurology
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Michigan State University, Sparrow Health System
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Advance Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Francis Medical Center
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08629
Country
United States
Facility Name
SUNY at Stony Brook, University Hospital at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Moses Cone Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Clinical Research Center of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Summa Health System Neurology and Neuroscience Associates
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States
Facility Name
Chattanooga Neurology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
The Methodist Hospital Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
INOVA Research Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Charleston Area Medical Center Health Education and Research Institute
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
General Hospital Middelheim, Dept. of Neurology
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Hopital Erasme - Dept. of Neurology, Universite Libre de Bruxelles
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Uz Gasthuisberg, Neurology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Universitatsklinikum Essen, Department of Neurology
City
Essen
ZIP/Postal Code
D-45147
Country
Germany
Facility Name
Neurologische Universitatsklinik und Poliklinik - Neurzentrum
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Leipzig Aor, Klinik And Poliklinok Fur Neurologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Neurologische Klinik, Klinikum Rechts Der Isar Der Tu Munchen
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Centralny Szpital Kliniczny
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Collegium Medicum Jegiellonian University
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
St Augustines Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Vergelegen Medi-Clinic
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Sunninghill Hospital Cnr.
City
Sunninghill
ZIP/Postal Code
2157
Country
South Africa
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
University Hospital of Girona Dr. Josep Trueta, Neurology Department
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospitales Universitarios Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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