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ACTIVE NOT RECRUITING
NCT05348785
PHASE2

A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80

Sponsor: Biogen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

650

Start Date

2022-04-19

Completion Date

2026-03-09

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

DRUG

BIIB122

Administered as specified in the treatment arm

DRUG

BIIB122-Matching Placebo

Administered as specified in the treatment arm

Locations (113)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

University of Southern California

Los Angeles, California, United States

Cedars Sinai

Los Angeles, California, United States

SC3 Research Group Inc.

Pasadena, California, United States

University of California San Francisco (UCSF)

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, United States

Invicro

New Haven, Connecticut, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

University of Miami

Miami, Florida, United States

Adventist Health System/Sunbelt, Inc.

Orlando, Florida, United States

USF Health Byrd Institute

Tampa, Florida, United States

Hawaii Pacific Neuroscience, LLC

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, United States

Boston University Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Mount Sinai Beth Israel

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Duke Movement Disorders Clinic

Durham, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

UPHS

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Neurology Clinic, PC

Cordova, Tennessee, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

Virginia Commonwealth University Department of Neurology

Richmond, Virginia, United States

Evergreen Hospital Medical Center

Kirkland, Washington, United States

Inland Northwest Research

Spokane, Washington, United States

Medizinische Universität

Innsbruck, Tyrol, Austria

Klinik Ottakring

Vienna, Austria

University of Calgary

Calgary, Alberta, Canada

True North Clinical Research

Halifax, Nova Scotia, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

CHUM Centre de Recherche

Montreal, Quebec, Canada

Montreal Neurological Institute

Montreal, Quebec, Canada

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Second Affiliated Hospital of Soochow University

Jiangsu, Jiangsu, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Hôpital de la Timone

Marseille, Bouches-du-Rhône, France

Hopital Purpan

Toulouse, Haute Garonne, France

Hopital Gui de Chauliac

Montpellier, Herault, France

CHU Rennes - Hopital Pontchaillou

Rennes, Ille Et Vilaine, France

CHU Nantes - Hopital Nord Laën

Loire-Atlantique, Loire-Atlantique, France

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, Puy De Dome, France

Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer

Bron, Rhone, France

Groupe Hospitalier Pitie-Salpetriere

Paris, France

Hopital Henri Mondor

Paris, France

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Klinikum der Universität München

Munich, Bavaria, Germany

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, Germany

Paracelsus-Elena-Klinik Kassel

Kassel, Hesse, Germany

Philipps University of Marburg

Marburg, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Katholisches Klinikum Bochum gGmbH

Bochum, North Rhine-Westphalia, Germany

Universitaetsklinikum Duesseldorf AoeR

Düsseldorf, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Saxony, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, Schleswig-Holstein, Germany

Rabin Medical Center

Petah Tikva, Israel

Center Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

I.R.C.C.S. Neuromed

Diego, Centonze, Italy

IRCCS-Institute of Neurological Sciences of Bologna

Bologna, Italy

Azienda Ospedaliera Spedali

Brescia, Italy

Azienda Ospedaliero Universitaria Policlinico 'Gaspare Rodolico - San Marco' (Presidio G. Rodolico)

Catania, Italy

Ospedale Clinicizzato SS. Annu

Chieti, Italy

Fondazione

Milan, Italy

Ospedale San Raffaele

Milan, Italy

AOU Luigi Vanvitelli

Naples, Italy

AO Universitaria Pisana

Pisa, Italy

IRCCS San Raffaele Pisana

Roma, Italy

Okinawa Prefectural Nanbu

Haeburu, Okinawa, Japan

Tazuke-kofukai Medical Research Institute Kitano Hospital

Osaka, Osaka, Japan

NHO Asahikawa Medical Center

Asahikawa-shi, Japan

Himeji Central

Himeji-shi, Japan

Sendai Nishitaga National Hospital

Sendai, Japan

Juntendo University

Tokyo, Japan

Brain Research Center Amsterdam

Amsterdam, Netherlands

Radboudumc

Nijmegen, Netherlands

Brain Research Center Zwolle B.V.

Zwolle, Netherlands

Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K

Oświęcim, Katowice, Poland

NeuroProtect Sp. z o.o.

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Neuromed

Bydgoszcz, Poland

Nzoz Novo-Med

Katowice, Poland

INSULA Centrum Badan Klinicznych

Warsaw, Poland

MD Clinic Praga

Warsaw, Poland

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Marques

Santanda, Santanda, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital de Cruces

Barakaldo, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Policlinica Gipuzkoa

Donostia / San Sebastian, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

University Hospitals Plymouth

Plymouth, Devon, United Kingdom

Re:Cognition Health Ltd (London)

London, Greater London, United Kingdom

Charing Cross Hospital

London, Greater London, United Kingdom

The National Hospital for Neurology & Neurosurgery

London, Greater London, United Kingdom

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, United Kingdom

NeuroClin Limited

Motherwell, Strathclyde, United Kingdom

Newcastle University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Re:Cognition Health - Birmingham

Birmingham, West Midlands, United Kingdom

Ninewells Hospital

Dundee, United Kingdom