A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80 (LUMA)

April 17, 2024 updated by: Biogen

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

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study:

  • Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it.
  • Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks.
  • Certain medications for PD will be allowed at enrollment for a subset of participants.
  • Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD.

To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BIIB122 is an investigational central nervous system-penetrant small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2). Participants who completed the early termination (ET) visit of the study 283PD302 (NCT05418673) would be eligible for screening of this study and if enrolled, these participants are not eligible for the sub studies of 283PD201.

Study Type

Interventional

Enrollment (Estimated)

640

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1160
        • Recruiting
        • Klinik Ottakring
        • Contact:
          • Phone Number: +431491502001
        • Principal Investigator:
          • Walter Pirker
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medizinische Universität
        • Principal Investigator:
          • Klaus Seppi
        • Contact:
          • Phone Number: +4351250481498
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • University of Calgary
        • Contact:
          • Phone Number: 8015852886
        • Principal Investigator:
          • Camila Aquino
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • Recruiting
        • True North Clinical Research
        • Principal Investigator:
          • Kerrie Schoffer
        • Contact:
          • Phone Number: 9024734327
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
          • Phone Number: 4166032581
        • Principal Investigator:
          • Emily Swinkin
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Recruiting
        • Montreal Neurological Institute
        • Contact:
          • Phone Number: 5149348026
        • Principal Investigator:
          • Anne-Louise Lafontaine
      • Montreal, Quebec, Canada, H2L 4M1
        • Recruiting
        • CHUM Centre de Recherche
        • Contact:
          • Phone Number: 5148908000
        • Principal Investigator:
          • Nicolas Jodoin
  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Hospital
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
    • Jiangsu
      • Jiangsu, Jiangsu, China, 215004
        • Recruiting
        • Second Affiliated Hospital of Soochow University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
  • France
      • Loire-Atlantique, France, 44093
        • Recruiting
        • CHU Nantes - Hopital Nord Laën
        • Principal Investigator:
          • Philippe Damier
        • Contact:
          • Phone Number: 33240165285
      • Paris, France, 94010
        • Recruiting
        • Hôpital Henri Mondor
        • Contact:
          • Phone Number: 33149812459
        • Principal Investigator:
          • Philippe Remy
      • Paris, France, 75013
        • Recruiting
        • Groupe Hospitalier Pitie-Salpetriere
        • Contact:
          • Phone Number: 33142165766
        • Principal Investigator:
          • Jean Christophe Corvol
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Recruiting
        • Hôpital de la Timone
        • Contact:
          • Phone Number: 33491384333
        • Principal Investigator:
          • Jean Philippe Azulay
    • Haute Garonne
      • Toulouse Cedex 09, Haute Garonne, France, TSA 40031
        • Recruiting
        • Hopital Purpan
        • Contact:
          • Phone Number: 33 (0)561 14 59 62
        • Principal Investigator:
          • Olivier Rascol
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Hopital Gui de Chauliac
        • Contact:
          • Phone Number: 3346733629
        • Principal Investigator:
          • Christian Geny
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, France, 35033
        • Recruiting
        • Chu Rennes - Hopital Pontchaillou
        • Contact:
          • Phone Number: 33299289564
        • Principal Investigator:
          • Sophie Drapier
    • Puy De Dome
      • Clermont Ferrand Cedex, Puy De Dome, France, 63003
        • Recruiting
        • CHU Clermont Ferrand - Hopital Gabriel Montpied
        • Contact:
          • Phone Number: 33473751600
        • Principal Investigator:
          • Ana-Raquel Marques
    • Rhone
      • Bron, Rhone, France, 69500
        • Recruiting
        • Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
        • Contact:
          • Phone Number: +33 825 08 25 69
        • Principal Investigator:
          • Stephane Thobois
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
        • Contact:
          • Phone Number: 493514582524
        • Principal Investigator:
          • Björn Falkenburger
      • Hannover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannov
        • Contact:
          • Phone Number: +49 89440046464
        • Principal Investigator:
          • Guenter Hoeglinger
      • Kassel, Germany, 34128
        • Recruiting
        • Paracelsus-Elena-Klinik Kassel
        • Principal Investigator:
          • Brit Mollenhauer
        • Contact:
          • Phone Number: +495616009200
      • Luebeck, Germany, 23538
        • Recruiting
        • University Hospital Schleswig
        • Contact:
          • Phone Number: + 49 451 500 43420
        • Principal Investigator:
          • Norbert Falkenburger Björn
      • Marburg, Germany, 35043
        • Recruiting
        • Universitätsklinikum Marburg
        • Principal Investigator:
          • Karla Eggert
        • Contact:
          • Phone Number: +49 6421 58 65439
      • Tuebingen, Germany, 72074
        • Recruiting
        • Universitaetsklinikum Tuebinge
        • Contact:
          • Phone Number: 4970710290
        • Principal Investigator:
          • Thomas Gasser
    • Baden Wuerttemberg
      • Ulm, Baden Wuerttemberg, Germany, 89081
        • Recruiting
        • Universitat Ulm
        • Principal Investigator:
          • Jan Kassubek
        • Contact:
          • Phone Number: 4973150050980
    • Bayern
      • Muenchen, Bayern, Germany, 81675
        • Recruiting
        • Katholisches Klinikum Bochum
        • Contact:
          • Phone Number: 498941404672
        • Principal Investigator:
          • Lars Toenges
      • Wuerzburg, Bayern, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
          • Phone Number: 4993120123751
        • Principal Investigator:
          • Jens Volkmann
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Phone Number: 49511532198
        • Principal Investigator:
          • Gunter Hoglinger
    • Nordrhein Westfalen
      • Bochum, Nordrhein Westfalen, Germany, 44791
        • Recruiting
        • Katholisches Klinikum Bochum gGmbH
        • Contact:
          • Phone Number: 492345092420
        • Principal Investigator:
          • Alfons Schnitzler
      • Duesseldorf, Nordrhein Westfalen, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf AoeR
        • Contact:
          • Phone Number: 492118116756
        • Principal Investigator:
          • Bernhard Haslinger
  • Israel
      • Petah Tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center
        • Contact:
          • Phone Number: +972 3 9378218
        • Principal Investigator:
          • Ruth Djaldetti
      • Ramat Gan, Israel, 5262000
        • Recruiting
        • Center Chaim Sheba Medical Center
        • Contact:
          • Phone Number: +972507746017
        • Principal Investigator:
          • Tsvia Fay-Karmon
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Tanya Gurevich
        • Contact:
          • Phone Number: +972306973949
  • Italy
      • Bologna, Italy, 40139
        • Recruiting
        • IRCCS-Institute of Neurological Sciences of Bologna
        • Principal Investigator:
          • Pietro Cortelli
        • Contact:
          • Phone Number: 390512092929
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali
        • Principal Investigator:
          • Alessandro Padovani
        • Contact:
          • Phone Number: 390303995260
      • Catania, Italy, 95123
        • Recruiting
        • U.O. Neurologia I
        • Contact:
          • Phone Number: +390953782783
        • Principal Investigator:
          • Mario Zappia
      • Chieti, Italy, 66100
        • Recruiting
        • Ospedale Clinicizzato SS. Annu
        • Contact:
          • Phone Number: +3286537740
        • Principal Investigator:
          • Astrid Thomas
      • Milano, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Massimo Filippi
        • Contact:
          • Phone Number: +390226435737
      • Milano, Italy, 20122
        • Recruiting
        • Fondazione
        • Principal Investigator:
          • Alessio Barnaba Di Fonzo
        • Contact:
          • Phone Number: 39 025 503 3847
      • Napoli, Italy, 80138
        • Recruiting
        • AOU Luigi Vanvitelli
        • Principal Investigator:
          • Alessandro Tessitore
        • Contact:
          • Phone Number: +390815665120
      • Pisa, Italy, 56126
        • Recruiting
        • AO Universitaria Pisana
        • Principal Investigator:
          • Roberto Ceravolo
        • Contact:
          • Phone Number: +39050993604
      • Roma, Italy, 00163
        • Recruiting
        • IRCCS San Raffaele Pisana
        • Contact:
          • Phone Number: +3908659291
        • Principal Investigator:
          • Laura Vacca
    • Centonze
      • Diego, Centonze, Italy, 86077
        • Recruiting
        • I.R.C.C.S. Neuromed
        • Contact:
          • Phone Number: 39865929250
        • Principal Investigator:
          • Diego Centonze
  • Japan
      • Asahikawa-shi, Japan, 070-8644
        • Recruiting
        • NHO Asahikawa Medical Center
      • Himeji-shi, Japan, 672-8043
        • Recruiting
        • Himeji Central
      • Sendai-shi, Japan, 982-8555
        • Recruiting
        • Sendai Nishitaga National Hospital
      • Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University
    • Okinawa
      • Haeburu, Okinawa, Japan, 901-1105
        • Recruiting
        • Okinawa Prefectural Nanbu
  • Netherlands
      • Amsterdam, Netherlands, 1081 GN
        • Recruiting
        • Brain Research Center Amsterdam
        • Contact:
          • Phone Number: 31205662500
        • Principal Investigator:
          • Rob de Bie
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc
        • Contact:
          • Phone Number: 31243615202
        • Principal Investigator:
          • Bastiaan Bloem
      • Zwolle, Netherlands, 8025 AZ
        • Recruiting
        • Brain Research Center Zwolle B.V.
        • Contact:
          • Phone Number: +31 38 202 6120
        • Principal Investigator:
          • Teus Van Laar
  • Poland
      • Bydgoszcz, Poland, 85-163
        • Recruiting
        • Centrum Medyczne Neuromed
        • Contact:
          • Phone Number: +48 513 904 844
        • Principal Investigator:
          • Pawel Lisewski
      • Katowice, Poland, 40-650
        • Recruiting
        • NZOZ Novo-Med
        • Contact:
          • Phone Number: 48322030106
        • Principal Investigator:
          • Tomasz Zielinski
      • Katowice, Poland, 40-588
        • Recruiting
        • Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
        • Contact:
          • Phone Number: 48501485317
        • Principal Investigator:
          • Magdalena Boczarska-Jedynak
      • Warszawa, Poland, 04-965
        • Recruiting
        • INSULA Centrum Badan Klinicznych
        • Contact:
          • Phone Number: +48 793 640 320
        • Principal Investigator:
          • Zanna Pastuszak Stepien
      • Warszawa, Poland, 03-505
        • Recruiting
        • MD Clinic Praga
        • Contact:
          • Phone Number: 48223265815
        • Principal Investigator:
          • Dariusz Koziorowski
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 01-684
        • Recruiting
        • Centrum Medyczne NeuroProtect
        • Contact:
          • Phone Number: +48226996015
        • Principal Investigator:
          • Maciej Czarnecki
  • Spain
      • A Coruna, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruna
        • Contact:
          • Phone Number: +34646173341
        • Principal Investigator:
          • Diego Santos García
      • Barakaldo, Spain, 48903
        • Recruiting
        • Hospital de Cruces
        • Contact:
          • Phone Number: +34946006363
        • Principal Investigator:
          • Juan Carlos Gomez Esteban
      • Barcelona, Spain, 8035
        • Recruiting
        • Hospital Universitari Vall D'Hebron
        • Principal Investigator:
          • Jorge Hernandez-Vara
        • Contact:
          • Phone Number: +34932746235
      • Barcelona, Spain, 8041
        • Recruiting
        • Hospital de La Santa Creu I Sant Pau
        • Principal Investigator:
          • Jaime Kulisevsky
        • Contact:
          • Phone Number: 34935537117
      • Barcelona, Spain, 8036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
          • Phone Number: 34932275785
        • Principal Investigator:
          • Marta Ferrer Puga
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
        • Contact:
          • Phone Number: +34915202416
        • Principal Investigator:
          • Lydia Lopez Manzanares
      • San Sebastian, Spain, 20014
        • Recruiting
        • Policlinica Gipuzkoa
        • Contact:
          • Phone Number: +34943002839818
        • Principal Investigator:
          • Gurutz Linazasoro Cristobal
      • Santanda, Spain, 38003
        • Recruiting
        • Hospital Universitario Marques
        • Contact:
          • Phone Number: +34942202507
        • Principal Investigator:
          • Jon Infante
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • Phone Number: 34955923039
        • Principal Investigator:
          • Pablo Mir Rivera
    • Barcelona
      • Sant Cugat del Valles, Barcelona, Spain, 8190
        • Recruiting
        • Hospital General de Catalunya
        • Contact:
          • Phone Number: 34931751575
        • Principal Investigator:
          • Ernest Balaguer Martinez
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Rosario Luquin Piudo
        • Contact:
          • Phone Number: 34948255400
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Recruiting
        • Ninewells Hospital
        • Principal Investigator:
          • Esther Sammler
        • Contact:
          • Phone Number: 441382660111
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Recruiting
        • University Hospitals Plymouth
        • Contact:
          • Phone Number: +4407810485465
        • Principal Investigator:
          • Stephen Mullin
    • Greater London
      • London, Greater London, United Kingdom, W6 8RF
        • Recruiting
        • Charing Cross Hospital
        • Contact:
          • Phone Number: +442033111714
        • Principal Investigator:
          • Yen Tai
      • London, Greater London, United Kingdom, WC1N 3BG
        • Recruiting
        • The National Hospital for Neurology & Neurosurgery
        • Contact:
          • Phone Number: +448451555000
        • Principal Investigator:
          • Huw Morris
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Recruiting
        • Salford Royal NHS Foundation Trust
        • Contact:
          • Phone Number: +44 16 12 06 05 34
        • Principal Investigator:
          • Montague Silverdale
    • Strathclyde
      • Motherwell, Strathclyde, United Kingdom, ML1 4UF
        • Recruiting
        • Glasgow Memory Clinic Ltd
        • Principal Investigator:
          • Donald Grosset
        • Contact:
          • Phone Number: 441412012486
    • Tyne And Wear
      • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE4 5PL
        • Recruiting
        • Newcastle University
        • Principal Investigator:
          • Nicola Pavese
        • Contact:
          • Phone Number: +448448115522
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
          • Phone Number: 480-342-3005
        • Principal Investigator:
          • Erika Driver-Dunkley
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Banner Sun Health Research Institute
        • Contact:
          • Phone Number: 623-832-6530
        • Principal Investigator:
          • David Shprecher
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai
        • Principal Investigator:
          • Michele Tagliati
        • Contact:
          • Phone Number: 310-248-6704
      • Pasadena, California, United States, 91105
        • Recruiting
        • SC3 Research Group Inc.
        • Contact:
          • Phone Number: 626-250-2070
        • Principal Investigator:
          • Lorraine Purino
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco (UCSF)
        • Contact:
          • Phone Number: 415-353-2211
        • Principal Investigator:
          • Marta San Luciano Palenzuela
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Phone Number: 303-724-5000
        • Principal Investigator:
          • Emily Forbes
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • CenExel Rocky Mountain Clinical Research
        • Contact:
          • Phone Number: 856-566-9000
        • Principal Investigator:
          • Rajeev Kumar
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Institute for Neurodegenerative Disorders (IND)
        • Contact:
          • Phone Number: 203-401-4300
        • Principal Investigator:
          • David Russell
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
        • Contact:
          • Phone Number: x2 561-392-1818
        • Principal Investigator:
          • Stuart Isaacson
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
          • Phone Number: 305-790-4246
        • Principal Investigator:
          • Jason H. Margolesky
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Adventist Health System/Sunbelt, Inc.
        • Contact:
          • Phone Number: 407-303-5600
        • Principal Investigator:
          • Anwar Ahmed
      • Tampa, Florida, United States, 33613
        • Recruiting
        • USF Health Byrd Institute
        • Contact:
          • Phone Number: 813-396-0606
        • Principal Investigator:
          • Robert Hauser
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience, LLC
        • Contact:
          • Phone Number: 808-261-4476
        • Principal Investigator:
          • Kore Liow
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
          • Phone Number: 312-942-5157
        • Principal Investigator:
          • Katie Kompoliti
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Danielle Larson
        • Contact:
          • Phone Number: 312-503-2970
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center Research Institute, Inc.
        • Contact:
          • Phone Number: 913-588-1261
        • Principal Investigator:
          • Rajesh Pahwa
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Phone Number: 617-667-0519
        • Principal Investigator:
          • Shabbir Merchant
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University Medical Center
        • Contact:
          • Phone Number: 617-638-7745
        • Principal Investigator:
          • Marie-Helene Saint-Hilaire
      • Boston, Massachusetts, United States, 02421
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Phone Number: 617-726-5532
        • Principal Investigator:
          • Anne-Marie Wills
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Quest Research Institute
        • Contact:
          • Phone Number: 248-957-8940
        • Principal Investigator:
          • Aaron Ellenbogen
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Mount Sinai Beth Israel
        • Principal Investigator:
          • Swan Matthew
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Medical College of Cornell University
        • Contact:
          • Phone Number: 212-746-1685
        • Principal Investigator:
          • Harini Sarva
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Movement Disorders Clinic
        • Principal Investigator:
          • Sneha Mantri
        • Contact:
          • Phone Number: 919-668-2905
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Contact:
          • Phone Number: 216-444-9715
        • Principal Investigator:
          • Michal T. Gostkowski
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • UPHS
        • Principal Investigator:
          • Andrew Siderowf
        • Contact:
          • Phone Number: 215-829-6500
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Principal Investigator:
          • Lana Chahine
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Phone Number: 843-792-3223
        • Principal Investigator:
          • Christine Cooper
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Neurology Clinic, PC
        • Contact:
          • Phone Number: 901-747-1111
        • Principal Investigator:
          • Kendrick Henderson
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital Research Institute
        • Principal Investigator:
          • William Ondo
        • Contact:
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Central Texas Neurology Consultants
        • Principal Investigator:
          • Elizabeth Peckham
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University Department of Neurology
        • Principal Investigator:
          • Matthew Barrett
        • Contact:
    • Washington
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • Evergreen Hospital Medical Center
        • Contact:
          • Phone Number: 425-899-1000
        • Principal Investigator:
          • Pinky Agarwal
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Inland Northwest Research
        • Contact:
          • Phone Number: 509-960-2818
        • Principal Investigator:
          • Jason Aldred

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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 (≤)40 at screening

Key Exclusion Criteria:

  • Clinically significant neurological disorder other than PD, including but not limited to stroke, dementia, or seizure, within 5 years of screening visit, in the opinion of the Investigator
  • Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
  • Montreal Cognitive Assessment (MoCA) score <24 at the screening visit.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: BIIB122
Administered as specified in the treatment arm
Other Names:
  • DNL151
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.
Drug: BIIB122-Matching Placebo
Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score Over the Treatment Period
Time Frame: Up to Week 144
Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (Range 0-184). A higher score indicates more severe symptoms of PD.
Up to Week 144

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 146
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Up to Week 146
Time to Confirmed Worsening in MDS-UPDRS Part II Score Over the Treatment Period
Time Frame: Up to a minimum of 48 weeks and a maximum of 144 weeks
Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be completed by the participant. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.
Up to a minimum of 48 weeks and a maximum of 144 weeks
Change From Baseline in MDS-UPDRS Parts II and III Combined Score
Time Frame: From Baseline up to Week 48
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be completed by the participant. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD. Part III assesses the motor signs of PD and is administered by the rater (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Parts II and III combined score equals the sum of Part II and III (Range 0-184). A higher score indicates more severe symptoms of PD.
From Baseline up to Week 48
Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score
Time Frame: From Baseline up to Week 48
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assesses non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and is assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which are to be completed by the participant (Range 0-28). Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS total score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicates more severe symptoms of PD.
From Baseline up to Week 48
Time to Confirmed Worsening in Modified Schwab and England Activities of Daily Living Scale (mSE-ADL) Over the Treatment Period
Time Frame: Up to a minimum of 48 weeks and a maximum of 144 weeks
Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. The mSE-ADL scale reflects the speed, ease, and independence with which an individual performs daily activities or personal chores with 100% indicating total independence, falling to 0%, which indicates a state of complete dependence. The individual is asked to rate his or her function using an 11-point scale (10% increments), from 100% (completely independent; able to do all chores without slowness, difficulty, or impairment; essentially normal; unaware of any difficulty) to 0% (vegetative functions such as swallowing, bladder and bowels are not functioning; bedridden). The lower the score, the worse the functional status.
Up to a minimum of 48 weeks and a maximum of 144 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Denali Therapeutics Inc.

Investigators

  • Study Director: Medical Director, Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 283PD201
  • 2021-004849-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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