A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale
NCT ID: NCT05418673
Last Updated: 2024-06-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
7 participants
INTERVENTIONAL
2022-08-26
2023-07-27
Brief Summary
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The main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD 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.
* The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms.
* The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms.
* Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety.
* Part II measures motor experiences of daily living.
* Part III is the results of a motor symptoms exam by a medical professional.
* Part IV records PD complications caused by motor symptoms.
Researchers will also learn more about the safety of BIIB122.
A description of how the study will be done is given below.
* Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine.
* Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods.
* Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks.
* Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins.
* Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BIIB122 225 mg
Participants will receive 225 mg of BIIB122 tablets, orally, once daily (QD) for up to 180 weeks.
BIIB122
Administered as specified in the treatment arm.
BIIB122-Matching Placebo
Participants will receive BIIB122-matching placebo tablets, orally, QD for up to 180 weeks.
BIIB122-Matching Placebo
Administered as specified in the treatment arm.
Interventions
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BIIB122
Administered as specified in the treatment arm.
BIIB122-Matching Placebo
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Modified Hoehn and Yahr scale (mHY), Stages 1 to 2.5 (in OFF state), inclusive, at Screening
* MDS-UPDRS Parts II and III (in OFF state) combined score ≤40 at Screening
* Screening genetic test results verifying the presence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant
Exclusion Criteria
* Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism
30 Years
80 Years
ALL
No
Sponsors
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Denali Therapeutics Inc.
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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University of California San Francisco (UCSF)
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, United States
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, United States
USF Health Byrd Institute
Tampa, Florida, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mount Sinai Beth Israel
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Evergreen Hospital Medical Center
Kirkland, Washington, United States
Inland Northwest Research
Spokane, Washington, United States
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France
Hopital Purpan
Toulouse, Haute Garonne, France
CHU Rennes - Hopital Pontchaillou
Rennes, Ille Et Vilaine, France
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
Bron, Rhone, France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Ninewells Hospital
Dundee, Tayside Region, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022-000747-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
283PD302
Identifier Type: -
Identifier Source: org_study_id
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