A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease

Status: Active_not_recruiting
Location: See all (113) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study. The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms. The main question researchers want to answer is: \- How long does it take for PD symptoms to worsen during BIIB122 treatment? Researchers will answer this and other questions by measuring the symptoms of PD over time using a variety of scoring tools. These include the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the modified Schwab and England Activities of Daily Living Scale (mSE-ADL). The MDS-UPDRS is used to measure symptoms of PD. It has 4 parts: Part I, II, III, and IV. Each part measures different aspects of motor and non-motor symptoms. The mSE-ADL measures a participant's ability to perform daily activities or personal chores. Researchers will also learn more about the safety of BIIB122. They will check participants for adverse events. Adverse events are unwanted health problems that may or may not be caused by the study drug. The study will be done as follows: * Participants will be randomly assigned to take either BIIBB122 or placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know if the participants are receiving BIIB122 or placebo. * Participants will take BIIB122 or placebo tablets by mouth once a day. * The treatment period for each participant will last between 48 and 144 weeks. * There will be a safety follow-up period for 2 weeks after the last dose of BIIB122. * In total, participants will have up to 29 study visits. * Participants will stay in the study for at least 1 year, up to about 3 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis

• Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at screening

• MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal to (≤)50 at screening

Locations
United States
Arizona
Mayo Clinic Arizona
Phoenix
Banner Sun Health Research Institute
Sun City
California
Cedars Sinai
Los Angeles
University of Southern California
Los Angeles
SC3 Research Group Inc.
Pasadena
University of California San Francisco (UCSF)
San Francisco
Colorado
University of Colorado
Aurora
CenExel Rocky Mountain Clinical Research
Englewood
Connecticut
Invicro
New Haven
Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton
University of Miami
Miami
Adventist Health System/Sunbelt, Inc.
Orlando
USF Health Byrd Institute
Tampa
Hawaii
Hawaii Pacific Neuroscience, LLC
Honolulu
Illinois
Northwestern University
Chicago
Rush University Medical Center
Chicago
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Boston University Medical Center
Boston
Massachusetts General Hospital
Boston
Michigan
Quest Research Institute
Farmington Hills
North Carolina
Duke Movement Disorders Clinic
Durham
New York
Mount Sinai Beth Israel
New York
Weill Medical College of Cornell University
New York
Ohio
The Cleveland Clinic Foundation
Cleveland
Pennsylvania
UPHS
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Neurology Clinic, PC
Cordova
Texas
The Methodist Hospital Research Institute
Houston
Central Texas Neurology Consultants
Round Rock
Virginia
Virginia Commonwealth University Department of Neurology
Richmond
Washington
Evergreen Hospital Medical Center
Kirkland
Inland Northwest Research
Spokane
Other Locations
Austria
Medizinische Universität
Innsbruck
Klinik Ottakring
Vienna
Canada
University of Calgary
Calgary
True North Clinical Research
Halifax
CHUM Centre de Recherche
Montreal
Montreal Neurological Institute
Montreal
Toronto Western Hospital
Toronto
China
Beijing Hospital
Beijing
Xuanwu Hospital Capital Medical University
Beijing
West China Hospital, Sichuan University
Chengdu
Second Affiliated Hospital of Soochow University
Jiangsu
France
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
Bron
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-ferrand
CHU Nantes - Hopital Nord Laën
Loire-atlantique
Hôpital de la Timone
Marseille
Hopital Gui de Chauliac
Montpellier
Groupe Hospitalier Pitie-Salpetriere
Paris
Hopital Henri Mondor
Paris
CHU Rennes - Hopital Pontchaillou
Rennes
Hopital Purpan
Toulouse
Germany
Katholisches Klinikum Bochum gGmbH
Bochum
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf
Medizinische Hochschule Hannover
Hanover
Paracelsus-Elena-Klinik Kassel
Kassel
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck
Philipps University of Marburg
Marburg
Klinikum der Universität München
Munich
Klinikum rechts der Isar der TU Muenchen
Munich
Universitaetsklinikum Tuebingen
Tübingen
Universitaetsklinikum Ulm
Ulm
Universitaetsklinikum Wuerzburg
Würzburg
Israel
Rabin Medical Center
Petah Tikva
Center Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
IRCCS-Institute of Neurological Sciences of Bologna
Bologna
Azienda Ospedaliera Spedali
Brescia
Azienda Ospedaliero Universitaria Policlinico 'Gaspare Rodolico - San Marco' (Presidio G. Rodolico)
Catania
Ospedale Clinicizzato SS. Annu
Chieti
I.R.C.C.S. Neuromed
Diego
Fondazione
Milan
Ospedale San Raffaele
Milan
AOU Luigi Vanvitelli
Napoli
AO Universitaria Pisana
Pisa
IRCCS San Raffaele Pisana
Roma
Japan
NHO Asahikawa Medical Center
Asahikawa-shi
Okinawa Prefectural Nanbu
Haeburu
Himeji Central
Himeji-shi
Tazuke-kofukai Medical Research Institute Kitano Hospital
Osaka
Sendai Nishitaga National Hospital
Sendai
Juntendo University
Tokyo
Netherlands
Brain Research Center Amsterdam
Amsterdam
Radboudumc
Nijmegen
Brain Research Center Zwolle B.V.
Zwolle
Poland
Centrum Medyczne Neuromed
Bydgoszcz
Nzoz Novo-Med
Katowice
Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
Oświęcim
INSULA Centrum Badan Klinicznych
Warsaw
MD Clinic Praga
Warsaw
NeuroProtect Sp. z o.o.
Warsaw
Spain
Complejo Hospitalario Universitario A Coruña
A Coruña
Hospital de Cruces
Barakaldo
Hospital Clinic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Policlinica Gipuzkoa
Donostia / San Sebastian
Hospital Universitario de La Princesa
Madrid
Clinica Universidad de Navarra
Pamplona
Hospital General de Catalunya
Sant Cugat Del Vallès
Hospital Universitario Marques
Santanda
Hospital Universitario Virgen del Rocio
Seville
United Kingdom
Re:Cognition Health - Birmingham
Birmingham
Ninewells Hospital
Dundee
Charing Cross Hospital
London
Re:Cognition Health Ltd (London)
London
The National Hospital for Neurology & Neurosurgery
London
NeuroClin Limited
Motherwell
Newcastle University
Newcastle Upon Tyne
University Hospitals Plymouth
Plymouth
Salford Royal NHS Foundation Trust
Salford
Time Frame
Start Date: 2022-04-19
Completion Date: 2026-03-09
Participants
Target number of participants: 650
Treatments
Experimental: BIIB122 225 mg
Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks.~Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.
Placebo_comparator: BIIB122 Matching Placebo
Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.~Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.
Related Therapeutic Areas
Sponsors
Leads: Biogen
Collaborators: Denali Therapeutics Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.