Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

237

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

July 31, 2026

Conditions
Parkinson's Disease
Interventions
DRUG

BIA 28-6156 10 mg

BIA 28-6156 10 mg, once daily, oral administration.

DRUG

BIA 28-6156 60 mg

BIA 28-6156 60 mg, once daily, oral administration.

DRUG

Placebo

Placebo, once daily, oral administration.

Trial Locations (95)

163

IRCSS San Raffaele Pisana, Roma

3801

Montreal Neurological Institute & Hospital, Montreal

6002

CHU de Nice Hopital Pasteur, Nice

10003

Icahn School of Medicine at Mount Sinai Beth Israel, New York

10021

Weil Cornell Medical Center, New York

10032

Columbia University Medical Center, New York

10075

Northwell Health, New York

14547

Neurologisches Fachkrankenhaus für, Bewegungsstörungen und Parkinson, Beelitz-Heilstätten

14642

University of Rochester Neurology, Rochester

19107

Parkinson's Disease and Movement Disorders Cente at University of Pennyslvania, Philadelphia

Thomas Jefferson University, Philadelphia

20086

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20133

IRCCS Carlo Besta Neurological Institute, Milan

21201

University of Maryland Medical Center, Baltimore

21287

Baylor University Medical Center, Baltimore

The Johns Hopkins University School of Medicine, Baltimore

25123

Spedali Civilia di Brescia, Brescia

28006

Hospital Universitaio de La Princesa, Madrid

28034

Hospital Ruber Internacional, Madrid

29425

MUSC, Charleston

30310

Morehouse School of Medicine, Atlanta

33136

University of Miami, Dept. of Neurology, Miami

33486

Parkinson's Center and Movement Disorders of Boca Raton, Boca Raton

34128

Paracelsus-Elena-Klinik, Kassel

34470

Renstar Medical Research, Ocala

35039

Universitats klinikum Marburg, Marburg

35128

Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica, Padua

35638

Gertrudis Clinic Biskirchen, Parkinson-Center, Biskirchen

37232

Vanderbilt Medical Center, Nashville

40536

University of Kentucky, Lexington

41013

Hospital Universitario Virgen del Rocio, Seville

43614

Univerity of Toledo, Toledo

44121

University Hospitals Cleveland Medical Center, South Euclid

44195

Cleveland Clinic Foundation, Cleveland

48334

Quest Research Institute, LLC, Farmington Hills

48903

Hospital Universitario Cruces, Barakaldo

52242

University of Iowa Hospitals and Clinics, Iowa City

55130

Struthers Parkinson's Center- East, Saint Paul

55427

Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners), Saint Paul

55905

Mayo Clinic, Rochester

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

66103

University of Kansas Medical Center, Kansas City

72100

Ospedale Antonio Perrino, Brindisi

77030

Baylor College of Medicine, Houston

77709

Parkinson-Klinik Ortenau GmbH&Co KG, Wolfach

78229

University of Texas Health Science Center - San Antonio, San Antonio

80045

University of Colorado, Aurora

80138

Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I, Napoli

81377

Klinikum der Universität München, Campus Grosshadern, Neurologische Klinik und Poliklinik, Munich

84107

Intermountain Healthcare, Salt Lake City

84125

A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT, Salerno

85013

Barrow Neurological Institute, Phoenix

90048

Cedars-Sinai, Los Angeles

92037

University of California San Diego, La Jolla

97239

Oregon Health and Science University, Portland

98034

Evergreen Neuroscience Institute, Kirkland

98195

University of Washington, Seattle

99202

Inland Northwest Research, Spokane

02114

Massachusetts General Hospital, Boston

02115

Beth Israel Deaconess Medical Center, Boston

08901

Robert Wood Johnson Medical School, New Brunswick

10075-1851

Northwell Health Physician Partners, New York

Unknown

Clinique Neuro-Outaouais (Neuro-Outaouais Clinic), Gatineau

Ottawa Hospital Research Institute, Ottawa

CHU de Nantes - Hopital Nord Laennec, Nantes

CHU de Nimes, Nîmes

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Pitie-Salpetriere - Centres d'Investigation Clinique (CIC) Paris-Est, Paris

CHU de Rennes Hopital Pontchaillou, Rennes

CIC Toulouse, Toulouse

Hopital Paule de Viguier, Toulouse

Ludwig-Maximilians University Munich, Munich

IRCCS Istituto Delle Scienze Neurologiche DI, Bologna

Amsterdam Medical Center UMC, Amsterdam

University Medical Center Groningen, Groningen

St. Antonius Ziekenhuis (St. Antonius Hospital) - Utrecht, Utrecht

Centro Hospitalar Universitario de Coimbra, Coimbra

CNS - Campus Neurologico, Torres Vedras

Neurologmottagningen, QD 62, Uppsala

NHS Tayside-Ninewells Hospital and Medical School, Dundee

Glasgow Memory Clinic, Glasgow

King's College London - David Goldberg Centre, London

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne

University Hospitals Plymouth NHS Trust, Plymouth

85-163

Centrum Medyczne NEUROMED Sp. z o.o. ul., Bydgoszcz

31-505

Krakowkska Akademia Neurologii Sp. z o.o, Krakow

90-640

NeuroKlinika Gabinet Lekarski, Lodz

4835-044

Hospital Senhora da Oliveira de Guimaraes, Guimarães

4099-001

Centro Hospitalar Universitario de Santo Antonio, Porto

4200-319

Hospital S.JOÃO, Porto

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08025

Hospital de la Santa Creu I Sant Pau, Barcelona

08035

Hospital Vall D´Hebron, Barcelona

221 85

Skane University Hospital, Lund University, Lund

All Listed Sponsors
lead

Bial R&D Investments, S.A.

INDUSTRY