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En studie for å evaluere effekten og sikkerheten til intravenøs Prasinezumab hos deltakere med tidlig Parkinsons sykdom

En fase IIB, randomisert, dobbeltblind, placebokontrollert, multisenterstudie for å evaluere effekten og sikkerheten til intravenøs Prasinezumab hos deltakere med tidlig Parkinsons sykdom

Sponsorer

Hovedsponsor: Hoffmann-La Roche

Samarbeider: Prothena Biosciences Limited

Kilde Hoffmann-La Roche
Kort oppsummering

Dette er en multisenter, randomisert, dobbeltblind, placebokontrollert studie som vil bli evaluert effekten og sikkerheten til intravenøs (IV) prasinezumab kontra placebo hos deltakere med Tidlig Parkinsons sykdom (PD) som er på stabil symptomatisk PD -medisinering.

Samlet status Rekruttering
Startdato 2021-05-05
Fullføringsdato 2024-01-22
Primær sluttdato 2023-11-13
Fase Fase 2
Studietype Intervensjonell
Primært utfall
Måle Tidsramme
Tid til meningsfylt utvikling på motoriske tegn på sykdommen, vurdert av> = 5 poeng økning i bevegelsessykdomssamfunn - enhetlig Parkinsons sykdomskala (MDS -UPDRS) Del III -poengsum fra baseline Fra baseline til 28 dager etter sluttdose studiebehandling
Sekundært utfall
Måle Tidsramme
Time-to-worsening of Participants Motor Function as Reported by the Participant in MDS-UPDRS Part II and Confirmed by the Clinician in MDS-UPDRS Part III From baseline until 28 days after final dose of study treatment
Tid til meningsfull forverring i pasientens globale inntrykk av endring (PGI-C, generell sykdomssubskala) Fra baseline til 28 dager etter sluttdose studiebehandling
Tid til en forverret forverring hos klinikerens globale inntrykk av endring (CGI-C, generell sykdomssubskala) Fra baseline til 28 dager etter sluttdose studiebehandling
Endring i motorfunksjon fra grunnlinje til uke 76, målt ved total score på MDS-UPDRS del III Fra baseline til uke 76
Endring i Bradykinesia fra baseline til uke 76, målt ved MDS-UPDRS del III Bradykinesia Subscore Fra baseline til uke 76
Endring i motoraspekter av dagliglivsopplevelser fra grunnlinje til uke 76, målt ved MDS-UPDRS del II Fra baseline til uke 76
Andel deltakere med bivirkninger (AE) og seriøse AE (SAE) Fra baseline til 70 dager etter sluttdose studiebehandling
Antall deltakere med bivirkninger av spesiell interesse (AESI) Fra baseline til 70 dager etter sluttdose studiebehandling
Antall deltakere med infusjonsrelaterte reaksjoner (IRR) Fra baseline til 70 dager etter sluttdose studiebehandling
Endring fra baseline i selvmordstanker, målt ved Columbia-Suicide Severity Rating Scale (C-SSRS) Fra baseline til 28 dager etter sluttdose studiebehandling
Serumkonsentrasjon av Prasinezumab Fra uke 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 og etter uke 76 hver 12. uke etter studiestart (ca. 28 dager etter sluttdosen)
Prosentandel deltakere med antistoffantistoffer (ADA) mot Prasinezumab ved baseline Ved baseline
Andel deltakere med ADA mot Prasinezumab under studien Fram til slutten av studiebesøket (ca. 76 uker)
Registrering 575
Tilstand
Innblanding

Intervensjonstype: Drug

Intervensjonsnavn: Prasinezumab

Beskrivelse: Prasinezumab will be administered as an IV infusion to participants Q4W.

Arm Group-etikett: Prasinezumab

Intervensjonstype: Legemiddel

Intervensjonsnavn: Placebo

Beskrivelse: Prasinezumab placebo vil bli gitt til deltakerne.

Arm Group-etikett: Placebo

Kvalifisering

Kriterier:

Inklusjonskriterier: - Diagnose av idiopatisk PD basert på MDS -kriterier med bradykinesi pluss en av andre kardinale tegn på PD (hvilestemning, stivhet), uten andre kjente eller mistenkt årsak til parkinsonisme - På symptomatisk PD -medisinering i minst 6 måneder, med stabile doser i 3 måneder før baseline - En diagnose av PD i minst 6 måneder til maksimalt 3 år ved screening - MDS-UPDRS Part IV score = 0 - Hoehn og Yahr (H&Y) trinn I eller II i tilstandene PÅ og AV - Dopamintransporter avbildning med enkelt fotonutslipp computertomografi (DaT-SPECT) bildediagnostikk som er i samsvar med underskudd på dopamintransportører, vurdert av sentral leser - Ingen forventede endringer i PD -medisinering fra baseline gjennom hele studietiden basert på klinisk status under screening - Villighet og evne til å bruke en smarttelefonapplikasjon til å måle PD-relaterte symptomer i løpet av studiet - Villighet og evne til å bruke en smartklokke for å måle PD-relaterte motorskilt Ekskluderingskriterier: - Medisinsk historie som indikerer et annet Parkinson -syndrom enn idiopatisk PD - Diagnose av PD -demens - Diagnose av en annen signifikant sykdom i sentralnervesystemet (CNS) enn Parkinsons sykdom - I løpet av det siste året, ustabil eller klinisk signifikant hjerte- og karsykdom - Ukontrollert hypertensjon - Narkotika- og/eller alkoholmisbruk innen 12 måneder før screening, hos etterforskeren dom (Nikotin er tillatt, bruk av marihuana er ikke tillatt) - Klinisk signifikante abnormiteter i laboratorietestresultater ved screening besøk, inkludert lever- og nyrepaneler, fullstendig blodtelling, kjemipanel og urinalyse - Allergi mot noen av komponentene i prasinezumab, en kjent overfølsomhet, eller a tidligere IRR etter administrering av et annet monoklonalt antistoff - Eventuelle kontraindikasjoner for å få hjernemagnetisk resonansavbildning (MR) - Eventuelle kontraindikasjoner for DaT-SPECT-avbildning

Kjønn:

Alle

Minimumsalder:

50 år

Maksimal alder:

85 år

Sunne frivillige:

Nei

Samlet offisiell
Etternavn Roll Tilhørighet
Clinical Trials Study Director Hoffmann-La Roche
Generell kontakt

Etternavn: Reference Study ID Number: BN42358 www.roche.com/about_roche/roche_worldwide.htm

Telefon: 888-662-6728 (U.S. and Canada)

E-post: [email protected]

plassering
Anlegget: Status:
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JEM Research LLC | Atlantis, Florida, 33462, United States Recruiting
Aventura Neurologic Associates; Department of Research | Aventura, Florida, 33180, United States Recruiting
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University of Florida Center For Movement Disorders And Neurorestoration | Gainesville, Florida, 32608, United States Not yet recruiting
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University of South Florida | Tampa, Florida, 33613-4706, United States Recruiting
Conquest Research, LLC | Winter Park, Florida, 32789, United States Not yet recruiting
Charter Research - Winter Park/Orlando | Winter Park, Florida, 32792, United States Recruiting
Northwestern University Feinberg School Of Medicine | Chicago, Illinois, 60611, United States Not yet recruiting
Southern Illinois University, School of Medicine | Springfield, Illinois, 62702, United States Recruiting
Indiana University Health University Hospital | Indianapolis, Indiana, 46202, United States Recruiting
University of Kansas Medical Center | Kansas City, Kansas, 66160, United States Not yet recruiting
Massachusetts General Hospital | Boston, Massachusetts, 02114-2759, United States Not yet recruiting
Quest Research Institute | Farmington Hills, Michigan, 48334, United States Recruiting
Henry Ford Hospital; Henry Ford Medical Center | West Bloomfield, Michigan, 48322, United States Recruiting
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Neuroscience Institute at Great Neck | New York, New York, 11021, United States Not yet recruiting
Raleigh Neurology Associates | Raleigh, North Carolina, 27607-6520, United States Recruiting
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The Movement Disorder Clinic of Oklahoma | Tulsa, Oklahoma, 74136, United States Recruiting
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Abington Neurological Associates Willow Grove | Willow Grove, Pennsylvania, 19090, United States Not yet recruiting
Texas Neurology PA | Dallas, Texas, 75206, United States Not yet recruiting
Baylor College of Medicine Medical Center | Houston, Texas, 77030, United States Recruiting
Central Texas Neurology Consultants | Round Rock, Texas, 78681, United States Recruiting
University of Vermont Medical Center | Burlington, Vermont, 05401, United States Not yet recruiting
Sentara Neurology Specialists | Norfolk, Virginia, 23507, United States Recruiting
Evergreen Health Care Center | Kirkland, Washington, 98034, United States Not yet recruiting
Inland Northwest Research | Spokane, Washington, 99202, United States Recruiting
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Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie | Innsbruck, 6020, Austria Recruiting
Klinik Ottakring; Neurologische Abteilung | Wien, 1160, Austria Not yet recruiting
Toronto Memory Program | Toronto, Ontario, M3B 2S7, Canada Recruiting
Toronto Western Hospital | Toronto, Ontario, M5T 2S8, Canada Not yet recruiting
Clinique Neuro Outaouais | Gatineau, Quebec, J8Y 1W2, Canada Recruiting
Montreal Neurological Institute and Hospital | Montreal, Quebec, H3A 2B4, Canada Not yet recruiting
Groupe Hospitalier Pellegrin | Bordeaux, 33000, France Not yet recruiting
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CHU de Limoges - Hôpital Dupuytren | Limoges, 87042, France Recruiting
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CHU de Nice Hopital Pasteur | Nice, 06002, France Recruiting
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CHU Strasbourg - Hôpital Hautepierre | Strasbourg, 67098, France Recruiting
CIC - Hôpital Purpan | Toulouse, 31059, France Recruiting
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Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease | Salerno, Campania, 84131, Italy Recruiting
Ospedale Bellaria; Istituto delle Scienze Neurologiche | Bologna, Emilia-Romagna, 40139, Italy Not yet recruiting
IRCCS San Raffaele Pisana; Clinical Trial Center | Roma, Lazio, 00163, Italy Recruiting
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Irccs A.O.U.San Martino Ist; Dinogmi | Genova, Liguria, 16132, Italy Not yet recruiting
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A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica | Catania, Sicilia, 95123, Italy Not yet recruiting
A.O. Universitaria Pisana; Neurologia | Pisa, Toscana, 56126, Italy Not yet recruiting
AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica | Perugia, Umbria, 06156, Italy Not yet recruiting
Azienda Ospedaliera S. Maria; SC Neurologia | Terni, Umbria, 05100, Italy Not yet recruiting
Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze | Padova, Veneto, 35128, Italy Not yet recruiting
NZOZ Vitamed | Bydgoszcz, 85-079, Poland Recruiting
Szpital Sw. Wojciecha; Oddzial Neurologiczny | Gdańsk, 80-462, Poland Recruiting
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Hospital Universitario Clínico San Carlos; Servicio de Neurología | Madrid, 28040, Spain Not yet recruiting
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Hospital Universitario Virgen Macarena; Servicio de Neurologia | Sevilla, 41009, Spain Recruiting
Hospital Virgen del Rocío; Servicio de Neurología | Sevilla, 41013, Spain Not yet recruiting
Hospital Universitario Dr. Peset; Servicio de Neurologia | Valencia, 46017, Spain Not yet recruiting
Hospital Universitari i Politecnic La Fe; Servicio de Neurología | Valencia, 46026, Spain Not yet recruiting
Servicio de Neurología Hospital Viamed Montecanal. | Zaragoza, 50012, Spain Not yet recruiting
Ninewells Hospital, Dundee- Scotland; Neurology | Dundee, DD2 1SY, United Kingdom Recruiting
Kings College Hospital | London, SE5 9RS, United Kingdom Not yet recruiting
Charing Cross Hospital | London, W6 8RF, United Kingdom Recruiting
Campus for Ageing and Vitality | Newcastle, NE4 5PL, United Kingdom Not yet recruiting
Oxford University Hospitals NHS Foundation Trust | Oxford, OX3 7LE, United Kingdom Recruiting
North West Anglia NHS Foundation Trust | Peterborough, PE3 9GZ, United Kingdom Recruiting
Derriford Hospital | Plymouth, PL6 8DH, United Kingdom Not yet recruiting
Lancashire Teaching Hospitals NHS Foundation Trust | Preston, PR5 6YA, United Kingdom Withdrawn
Sted Land

Austria

Canada

France

Italy

Poland

Spain

United Kingdom

United States

Bekreftelsesdato

2021-10-01

Ansvarlig fest

Type: Sponsor

Har utvidet tilgang Nei
Antall våpen 2
Arm Group

Merkelapp: Prasinezumab

Type: Experimental

Beskrivelse: Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W).

Merkelapp: Placebo

Type: Placebo -sammenligning

Beskrivelse: Deltakerne vil få placebo som en IV -infusjon Q4W.

Forkortelse PADOVA
Informasjon om studiedesign

Tildeling: Tilfeldig

Intervensjonsmodell: Parallell oppgave

Hovedformål: Behandling

Maskering: Dobbelt (deltaker, etterforsker)

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