Parkinson's Disease| Part A (SAD): BIIB094 Dose 1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson’s Disease
Purpose of Study
The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson's Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic variant.
Age:35 - 80
Key Inclusion / Exclusion Criteria
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
- Diagnosed with PD within 7 years at the time of initial enrollment (i.e., at time of SAD enrollment for rollover participants), without major motor fluctuations or dyskinesia that may interfere with study treatment and assessments in the opinion of the investigator after consultation with the Sponsor.
- Modified Hoehn and Yahr Stage ≤ 3.
- Montreal Cognitive Assessment (MoCA) score less than (
- History of any brain surgery for PD or a history of focused ultrasound treatment at any time; or history of neuromodulation procedures.
- Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year before Screening.
- History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities within 1 year before Screening.
- Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobin value greater than or equal to (≥) 8 percent (%) at Screening.
- History or positive test result at Screening for human immunodeficiency virus.
- History or positive test result at Screening for hepatitis C virus antibody.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical Trials ID
Read Detailed Summary:
Start Date / End Date:
08 2019 - 12 2023
Part A (SAD): BIIB094 Dose 1
18 Study Locations
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Quest Research Institute
Farmington Hills, Michigan, 48334
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Alliance for Multispecialty Research NOCCR/VRG
Knoxville, Tennessee, 37920
Inland Northwest Research
Spokane, Washington, 99202
Montreal Neurological Institute and Hospital
Montreal, Quebec, QC H3A 2B4
Laboratorios de Investigación Biocruces 3., Hospital de Cruces
Barakaldo, Bizkaia, 48903
Hospital General de Catalunya
Barcelona, Vizcaya, 08195
Hospital Clinic de Barcelona
Hospital General Universitario Gregorio Marañón
Queen Square (Neurology) CRF Site Institute of Neurology & the National Hospital for Neurology and Neurosurgery UCLH
London, WC1N 3BG
phone: +44 0203 44 84531