What is the Purpose of this Study?
The purpose of this study is to evaluate whether an experimental drug called BIIB122 is safe and tolerable in LRRK2-associated Parkinson’s disease (LRRK2-PD) patients. LRRK2-PD is a form of Parkinson’s disease caused by genetic mutation(s) that increase the activity of the LRRK2 gene. LRRK2-PD is similar to other forms of Parkinson’s disease in that there are differences within the brain that cause people to have movements they cannot control. BIIB122 inhibits the activity of LRRK2.
The study will also use blood and cerebrospinal fluid (body fluid that surrounds the brain and spinal cord) to measure proteins in the body that provide information about Parkinson’s disease (biomarkers). Study procedures include drug administration, blood draws, electrocardiogram, evaluations, lumbar punctures, and imaging. Participants will be randomly assigned to receive either BIIB122 or placebo (inactive substance).
Eligibility
- * For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
- * 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.
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Inclusion Criteria:
- * For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
- * 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 a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.
- * 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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease