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

19. oktober 2015 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

43

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
piclozotan IV infusion, low dose, for 72 hours.
Legemiddel: piclozotan low dose
Continuous IV infusion over a period of up to 72 hours of piclozotan
Eksperimentell: 2
piclozotan IV infusion, high dose, for 72 hours.
Legemiddel: piclozotan high dose
Continuous IV infusion over a period of up to 72 hours of piclozotan
Placebo komparator: 3
placebo (normal saline) IV infusion, for 72 hours.
Legemiddel: placebo
Continuous IV infusion over a period of up to 72 hours of placebo.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Improvement in MRI
Tidsramme: 28 days
28 days

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Daiichi Sankyo, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2004

Primær fullføring (Faktiske)

1. oktober 2006

Studiet fullført (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først innsendt

5. januar 2006

Først innsendt som oppfylte QC-kriteriene

5. januar 2006

Først lagt ut (Anslag)

9. januar 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. oktober 2015

Sist bekreftet

1. oktober 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SPI-103

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Legemiddelintervensjoner

CROs by country

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Forhold

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