A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease
NCT ID: NCT03976349
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2019-08-12
2024-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part A (SAD): BIIB094 Dose 1
Participants will receive a single IT injection of BIIB094 during Part A \[Single Ascending Dose (SAD)\].
BIIB094
Administered as specified in the treatment arm.
Part A (SAD): BIIB094 Dose 2
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
BIIB094
Administered as specified in the treatment arm.
Part A (SAD): BIIB094 Dose 3
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
BIIB094
Administered as specified in the treatment arm.
Part A (SAD): BIIB094 Dose 4
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
BIIB094
Administered as specified in the treatment arm.
Part A (SAD): BIIB094 Dose 5
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
BIIB094
Administered as specified in the treatment arm.
Part A (SAD): BIIB094 Dose 6
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
BIIB094
Administered as specified in the treatment arm.
Part B (MAD): BIIB094 Dose 1
Participants will receive a single IT injection of BIIB094 on multiple days during Part B \[Multiple Ascending Dose (MAD)\].
BIIB094
Administered as specified in the treatment arm.
Part B (MAD): BIIB094 (Non LRRK2) Dose 2
Participants \[Non leucine-rich repeat kinase 2 (Non LRRK2)\] will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
BIIB094
Administered as specified in the treatment arm.
Part B (MAD): BIIB094 (LRRK2) Dose 2
Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
BIIB094
Administered as specified in the treatment arm.
Part B (MAD): BIIB094 (Non LRRK2) Dose 3
Participants (Non LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
BIIB094
Administered as specified in the treatment arm.
Part B (MAD): BIIB094 (LRRK2) Dose 3
Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
BIIB094
Administered as specified in the treatment arm.
Part A (SAD): Matching Placebo
Participants will receive matching placebo during Part A \[Single Ascending Dose (SAD)\].
Placebo
Administered as specified in the treatment arm.
Part B (MAD): Matching Placebo
Participants will receive matching placebo on multiple days during Part B (MAD).
Placebo
Administered as specified in the treatment arm.
Interventions
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BIIB094
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
35 Years
80 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2018-002995-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
254PD101
Identifier Type: -
Identifier Source: org_study_id
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