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
- Conditions
- Parkinson Disease
- Interventions
- Drug: BIIB122-Matching Placebo
- Registration Number
- NCT05348785
- Lead Sponsor
- Biogen
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 650
- 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
Key
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIIB122 Matching Placebo 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. BIIB122 225 mg BIIB122 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.
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Time to Confirmed Worsening in MDS-UPDRS Part II Score Over the Treatment Period 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.
Change From Baseline in MDS-UPDRS Parts II and III Combined Score 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) 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.
Time to Confirmed Worsening in Modified Schwab and England Activities of Daily Living Scale (mSE-ADL) Over the Treatment Period 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.
Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score 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.
Trial Locations
- Locations (113)
Hopital Henri Mondor
🇫🇷Paris, France
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, China
Beijing Hospital
🇨🇳Beijing, Beijing, 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 Cedex 09, Haute Garonne, France
Hopital Gui de Chauliac
🇫🇷Montpellier, Herault, France
CHU Rennes - Hopital Pontchaillou
🇫🇷Rennes, Ille Et Vilaine, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
🇫🇷Clermont Ferrand Cedex, Puy De Dome, France
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
🇫🇷Bron, Rhone, France
CHU Nantes - Hopital Nord Laën
🇫🇷Loire-Atlantique, France
Groupe Hospitalier Pitie-Salpetriere
🇫🇷Paris, France
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Baden Wuerttemberg, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden Wuerttemberg, Germany
Klinikum der Universität München
🇩🇪Muenchen, Bayern, Germany
Klinikum rechts der Isar der TU Muenchen
🇩🇪Muenchen, Bayern, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Bayern, Germany
Paracelsus-Elena-Klinik Kassel
🇩🇪Kassel, Hessen, Germany
Philipps University of Marburg
🇩🇪Marburg, Hessen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Katholisches Klinikum Bochum gGmbH
🇩🇪Bochum, Nordrhein Westfalen, Germany
Universitaetsklinikum Duesseldorf AoeR
🇩🇪Duesseldorf, Nordrhein Westfalen, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
🇩🇪Dresden, Sachsen, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
🇩🇪Luebeck, 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
🇮🇹Milano, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
AOU Luigi Vanvitelli
🇮🇹Napoli, 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-shi, Osaka-Fu, Japan
NHO Asahikawa Medical Center
🇯🇵Asahikawa-shi, Japan
Himeji Central
🇯🇵Himeji-shi, Japan
Sendai Nishitaga National Hospital
🇯🇵Sendai-shi, 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
🇵🇱Oswiecim, Katowice, Poland
NeuroProtect Sp. z o.o.
🇵🇱Warsaw, Mazowieckie, Poland
Centrum Medyczne Neuromed
🇵🇱Bydgoszcz, Poland
Nzoz Novo-Med
🇵🇱Katowice, Poland
INSULA Centrum Badan Klinicznych
🇵🇱Warszawa, Poland
MD Clinic Praga
🇵🇱Warszawa, Poland
Hospital General de Catalunya
🇪🇸Sant Cugat del Valles, Barcelona, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruna, 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
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Policlinica Gipuzkoa
🇪🇸San Sebastian, Spain
Hospital Universitario Marques
🇪🇸Santanda, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, 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