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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease
NCT03976349 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BIIB094
Study Locations (18)
Other
- Sourasky Medical Center — Tel Aviv
- Neuro-SysMed Center — Bergen
- St. Olav University Hospital — Trondheim
- Hospital Clinic de Barcelona — Barcelona
- Hospital General Universitario Gregorio Marañón — Madrid
- Research Site — Seville
- Queen Square (Neurology) CRF Site Institute of Neurology & the National Hospital for Neurology and Neurosurgery UCLH — London
Illinois
- Northwestern University PD and Movement Disorders Center — Chicago
Michigan
- Quest Research Institute — Farmington Hills
Ohio
- The Cleveland Clinic Foundation — Cleveland
Oregon
- Oregon Health and Science University — Portland
Pennsylvania
- University of Pennsylvania — Philadelphia
Tennessee
- Alliance for Multispecialty Research — Knoxville
Washington
- Inland Northwest Research — Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2024-08-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03976349
The ClinicalTrials.gov registry entry for NCT03976349 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03976349 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Other, Illinois, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03976349 about?
NCT03976349 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease". 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 B...
What is the current status of trial NCT03976349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2019-08-12. Estimated completion is 2024-08-12.
What conditions does trial NCT03976349 study?
This clinical trial studies the following conditions: Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03976349?
The interventions under investigation include: Placebo (DRUG), BIIB094 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03976349?
This trial is sponsored by Ionis Pharmaceuticals, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03976349 being conducted?
This trial has 18 study locations across Illinois, Michigan, Ohio, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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