Condition: Parkinson's Disease · Sponsor: Ionis Pharmaceuticals, Inc.
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Key Inclusion 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. Key Exclusion Criteria: * Montreal Cognitive Assessment (MoCA) score less than (\<) 23, dementia, or other significant cognitive impairment that, in the opinion of the Investigator, would interfere with study evaluation. * 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 6 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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