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NCT03976349 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease
A Phase 1 study of Parkinson's Disease, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 18
- Study locations
NCT03976349: Completed Phase 1 study of Parkinson's Disease, sponsored by Ionis Pharmaceuticals.
NCT03976349 is a Phase 1 study of Parkinson's Disease that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 62 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (90% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03976349, a Phase 1 study of Parkinson's Disease, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have cau
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 |
What the finished NCT03976349 record still lists
NCT03976349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (90% lower).
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.
NCT03976349 lists 18 locations in 12 states (Other, Illinois, Michigan).
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.
What interventions are being tested in trial NCT03976349?
The interventions under investigation include: Placebo (DRUG), BIIB094 (DRUG).
Who is sponsoring clinical trial NCT03976349?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03976349's enrollment target sits among peer trials
62 74th of 158 higher than 85 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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