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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

43

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Antwerp, Belgien, 2020
        • General Hospital Middelheim, Dept. of Neurology
      • Brussels, Belgien, B-1070
        • Hopital Erasme - Dept. of Neurology, Universite Libre de Bruxelles
      • Leuven, Belgien, 3000
        • Uz Gasthuisberg, Neurology
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90024
        • UCLA Stroke Network
      • San Francisco, California, Forenede Stater, 94109
        • San Francisco Clinical Research Center
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06102
        • The Stroke Center at Hartford Hospital
    • Florida
      • Lakeland, Florida, Forenede Stater, 33805
        • Lakeland Regional Medical Center
      • Ocala, Florida, Forenede Stater, 34471
        • Ocala Neurodiagnostic Center
    • Illinois
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50314
        • Ruan Neurology Clinic and Clinical Research Center
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Regional Medical Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky, Sanders Brown Center on Aging/Stroke Program
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts, Memorial Health Center, Department of Neurology
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University
      • East Lansing, Michigan, Forenede Stater, 48824
        • Michigan State University, Sparrow Health System
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • St. Luke's Hospital
    • Montana
      • Great Falls, Montana, Forenede Stater, 59405
        • Advance Neurology Specialists
    • New Jersey
      • Trenton, New Jersey, Forenede Stater, 08629
        • St. Francis Medical Center
    • New York
      • Stony Brook, New York, Forenede Stater, 11794
        • SUNY at Stony Brook, University Hospital at Stony Brook
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Moses Cone Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Clinical Research Center of Winston-Salem
    • Ohio
      • Akron, Ohio, Forenede Stater, 44309
        • Summa Health System Neurology and Neuroscience Associates
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Chattanooga Neurology Associates
      • Memphis, Tennessee, Forenede Stater, 38104
        • Methodist University Hospital
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • The Methodist Hospital Neurological Institute
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Research Center
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • Charleston Area Medical Center Health Education and Research Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede 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
  • Spanien
      • Barcelona, Spanien, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Girona, Spanien, 17007
        • University Hospital of Girona Dr. Josep Trueta, Neurology Department
      • Sevilla, Spanien, 41013
        • Hospitales Universitarios Virgen del Rocío
  • Sydafrika
      • Durban, Sydafrika, 4001
        • St Augustines Hospital
      • Somerset West, Sydafrika, 7130
        • Vergelegen Medi-Clinic
      • Sunninghill, Sydafrika, 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
piclozotan IV infusion, low dose, for 72 hours.
Medicin: piclozotan low dose
Continuous IV infusion over a period of up to 72 hours of piclozotan
Eksperimentel: 2
piclozotan IV infusion, high dose, for 72 hours.
Medicin: 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.
Medicin: placebo
Continuous IV infusion over a period of up to 72 hours of placebo.

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Daiichi Sankyo, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2004

Primær færdiggørelse (Faktiske)

1. oktober 2006

Studieafslutning (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først indsendt

5. januar 2006

Først indsendt, der opfyldte QC-kriterier

5. januar 2006

Først opslået (Skøn)

9. januar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SPI-103

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med piclozotan low dose

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Montenegro

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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