Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
NCT ID: NCT06602193
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2024-10-24
2028-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT05418673
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
NCT05348785
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease
NCT03716570
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease
NCT03976349
Study to Evaluate SYN115 in Parkinson's Disease
NCT00605553
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIIB122 225 mg
Oral 225 mg dose, once daily (QD)
BIIB122 225 mg
Administered as specified in the treatment arm
BIIB122 Matching Placebo
Oral BIIB122 matching placebo, once daily (QD)
BIIB122-Matching Placebo
Administered as specified in the treatment arm
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIIB122 225 mg
Administered as specified in the treatment arm
BIIB122-Matching Placebo
Administered as specified in the treatment arm
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
* Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
* Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.
Exclusion Criteria
* Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
* Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).
* Have previously participated or are currently participating in a gene therapy study for PD.
* Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).
* Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).
* Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature
* Have abnormal PFT results at screening
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Denali Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Danna Jennings, MD
Role: STUDY_DIRECTOR
Denali Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars-Sinai Department of Neurology
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York, New York, United States
Evergreen Health Laboratory
Kirkland, Washington, United States
Inland Northwest Research
Spokane, Washington, United States
Technische Universität Dresden
Dresden, , Germany
University of Lübeck
Lübeck, , Germany
University Hospital Tübingen
Tübingen, , Germany
Hospital Universitari General de Catalunya
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Donostia
Donostia / San Sebastian, , Spain
Universitary Hospital La Princesa
Madrid, , Spain
IDIVAL/University Hospital Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DNLI-C-0009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.