Phase
Condition
Dyskinesias
Dystonias
Tic Disorders
Treatment
BIIB122 225 mg
BIIB122-Matching Placebo
Clinical Study ID
Ages > 30 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 LRRK2variant.
Have a clinical diagnosis of PD meeting the Movement Disorder Society ClinicalDiagnostic Criteria.
Exclusion
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 theinvestigator, within 5 years of the screening visit.
Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy orprogressive supranuclear palsy) or evidence of drug-induced parkinsonism.
Have previously participated or are currently participating in the BIIB122 LUMAstudy (Study 283PD201).
Have previously participated or are currently participating in a gene therapy studyfor 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) overtime (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanentphysical disability).
Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature
Have abnormal PFT results at screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
Connect with a study center
Technische Universität Dresden
Dresden,
GermanySite Not Available
Technische Universität Dresden
Dresden 2935022,
GermanyActive - Recruiting
University of Lübeck
Lübeck,
GermanySite Not Available
University of Lübeck
Lübeck 2875601,
GermanyActive - Recruiting
University Hospital Tübingen
Tübingen,
GermanySite Not Available
University Hospital Tübingen
Tübingen 2820860,
GermanyActive - Recruiting
Rabin Medical Center
Petah Tikva 293918,
IsraelActive - Recruiting
Movement Disorders Institute, Sheba Medical Center
Ramat Gan 293788,
IsraelActive - Recruiting
Tel Aviv Medical Center
Tel Aviv 293397,
IsraelActive - Recruiting
Hospital Universitari General de Catalunya
Barcelona,
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona,
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona 3128760,
SpainActive - Recruiting
Hospital Universitari General de Catalunya
Barcelona 3128760,
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona 3128760,
SpainActive - Recruiting
Hospital Universitario Donostia
Donostia,
SpainSite Not Available
Hospital Universitario Donostia
Donostia / San Sebastian 3110044,
SpainActive - Recruiting
Universitary Hospital La Princesa
Madrid,
SpainSite Not Available
Universitary Hospital La Princesa
Madrid 3117735,
SpainActive - Recruiting
IDIVAL/University Hospital Marques de Valdecilla
Santander,
SpainSite Not Available
IDIVAL/University Hospital Marques de Valdecilla
Santander 3109718,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla,
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Seville 2510911,
SpainActive - Recruiting
Cedars-Sinai Department of Neurology
Los Angeles, California 90048
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94158
United StatesSite Not Available
Cedars-Sinai Department of Neurology
Los Angeles 5368361, California 5332921 90048
United StatesActive - Recruiting
University of California San Francisco
San Francisco 5391959, California 5332921 94158
United StatesActive - Recruiting
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida 33486
United StatesSite Not Available
Parkinson's Disease and Movement Disorders Center
Boca Raton 4148411, Florida 4155751 33486
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York, New York 10003
United StatesSite Not Available
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York 5128581, New York 5128638 10003
United StatesActive - Recruiting
Evergreen Health Laboratory
Kirkland, Washington 98034
United StatesSite Not Available
Inland Northwest Research
Spokane, Washington 99202
United StatesSite Not Available
Evergreen Health Laboratory
Kirkland 5799841, Washington 5815135 98034
United StatesActive - Recruiting
Inland Northwest Research
Spokane 5811696, Washington 5815135 99202
United StatesActive - Recruiting

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