A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease
Completed · Phase 1 · Has a placebo group
Conditions studied: Parkinson's Disease
In brief
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.
Key facts
- Study ID
- NCT03976349
- Run by
- Ionis Pharmaceuticals, Inc.
- People needed
- 62
- Starts
- 2019-08-12
- Expected to finish
- 2024-08-12
- Last updated by the study team
- 2025-09-23
Who can join
Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Northwestern University PD and Movement Disorders Center — Chicago, Illinois, United States
- Quest Research Institute — Farmington Hills, Michigan, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Oregon Health and Science University — Portland, Oregon, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Alliance for Multispecialty Research — Knoxville, Tennessee, United States
- Inland Northwest Research — Spokane, Washington, United States
- Research Site — Toronto, Ontario, Canada
- Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada
- Sourasky Medical Center — Tel Aviv, Israel
- Neuro-SysMed Center — Bergen, Norway
- St. Olav University Hospital — Trondheim, Norway
- Laboratorios de Investigación Biocruces 3., Hospital de Cruces — Barakaldo, Bizkaia, Spain
- Hospital General de Catalunya — Barcelona, Vizcaya, Spain
- Hospital Clinic de Barcelona — Barcelona, Spain
- Hospital General Universitario Gregorio Marañón — Madrid, Spain
- Research Site — Seville, Spain
- Queen Square (Neurology) CRF Site Institute of Neurology & the National Hospital for Neurology and Neurosurgery UCLH — London, United Kingdom
Full record on ClinicalTrials.gov
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