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)
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Early-stage Parkinson Disease
Eligibility Criteria
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
- Screening genetic test results verifying the absence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.
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.
Sites / Locations
- Mayo Clinic ArizonaRecruiting
- Banner Sun Health Research InstituteRecruiting
- Cedars SinaiRecruiting
- SC3 Research Group Inc.Recruiting
- University of California San Francisco (UCSF)Recruiting
- University of ColoradoRecruiting
- CenExel Rocky Mountain Clinical ResearchRecruiting
- Institute for Neurodegenerative Disorders (IND)Recruiting
- Parkinson's Disease and Movement Disorders Center of Boca RatonRecruiting
- University of MiamiRecruiting
- Adventist Health System/Sunbelt, Inc.Recruiting
- USF Health Byrd InstituteRecruiting
- Hawaii Pacific Neuroscience, LLCRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- University of Kansas Medical Center Research Institute, Inc.Recruiting
- Boston University Medical CenterRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Massachusetts General HospitalRecruiting
- Quest Research InstituteRecruiting
- Mount Sinai Beth IsraelRecruiting
- Weill Medical College of Cornell UniversityRecruiting
- Duke Movement Disorders ClinicRecruiting
- The Cleveland Clinic FoundationRecruiting
- UPHSRecruiting
- University of PittsburghRecruiting
- Medical University of South CarolinaRecruiting
- Neurology Clinic, PCRecruiting
- The Methodist Hospital Research InstituteRecruiting
- Virginia Commonwealth University Department of NeurologyRecruiting
- Evergreen Hospital Medical CenterRecruiting
- Inland Northwest ResearchRecruiting
- Medizinische UniversitätRecruiting
- Klinik OttakringRecruiting
- University of CalgaryRecruiting
- True North Clinical ResearchRecruiting
- Toronto Western HospitalRecruiting
- CHUM Centre de RechercheRecruiting
- Montreal Neurological InstituteRecruiting
- Xuanwu Hospital Capital Medical UniversityRecruiting
- Beijing HospitalRecruiting
- Second Affiliated Hospital of Soochow UniversityRecruiting
- West China Hospital, Sichuan UniversityRecruiting
- Hôpital de la TimoneRecruiting
- Hopital PurpanRecruiting
- Hopital Gui de ChauliacRecruiting
- CHU Rennes - Hopital PontchaillouRecruiting
- CHU Clermont Ferrand - Hopital Gabriel MontpiedRecruiting
- Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre WertheimerRecruiting
- CHU Nantes - Hopital Nord LaënRecruiting
- Groupe Hospitalier Pitie-SalpetriereRecruiting
- Hopital Henri MondorRecruiting
- Universitat UlmRecruiting
- Katholisches Klinikum BochumRecruiting
- Universitaetsklinikum WuerzburgRecruiting
- Medizinische Hochschule HannoverRecruiting
- Katholisches Klinikum Bochum gGmbHRecruiting
- Universitaetsklinikum Duesseldorf AoeRRecruiting
- Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
- Paracelsus-Elena-Klinik KasselRecruiting
- Universitätsklinikum MarburgRecruiting
- Universitaetsklinikum TuebingeRecruiting
- Rabin Medical CenterRecruiting
- Center Chaim Sheba Medical CenterRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- I.R.C.C.S. NeuromedRecruiting
- IRCCS-Institute of Neurological Sciences of BolognaRecruiting
- Azienda Ospedaliera SpedaliRecruiting
- U.O. Neurologia IRecruiting
- Ospedale Clinicizzato SS. AnnuRecruiting
- Ospedale San RaffaeleRecruiting
- AO Universitaria PisanaRecruiting
- IRCCS San Raffaele PisanaRecruiting
- Okinawa Prefectural NanbuRecruiting
- NHO Asahikawa Medical CenterRecruiting
- Himeji CentralRecruiting
- Sendai Nishitaga National HospitalRecruiting
- Juntendo UniversityRecruiting
- Brain Research Center AmsterdamRecruiting
- RadboudumcRecruiting
- Brain Research Center Zwolle B.V.Recruiting
- Centrum Medyczne NeuroProtectRecruiting
- Centrum Medyczne NeuromedRecruiting
- Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.KRecruiting
- Nzoz Novo-MedRecruiting
- MD Clinic PragaRecruiting
- INSULA Centrum Badan KlinicznychRecruiting
- Hospital General de CatalunyaRecruiting
- Clinica Universidad de NavarraRecruiting
- Complejo Hospitalario Universitario A CoruñaRecruiting
- Hospital de CrucesRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitario de La PrincesaRecruiting
- Policlinica GipuzkoaRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- University Hospitals PlymouthRecruiting
- The National Hospital for Neurology & NeurosurgeryRecruiting
- Salford Royal NHS Foundation TrustRecruiting
- Glasgow Memory Clinic LtdRecruiting
- Newcastle UniversityRecruiting
- Ninewells HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BIIB122 225 mg
BIIB122 Matching Placebo
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.
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.