A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease
NCT ID: NCT03716570
Last Updated: 2021-05-25
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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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2019-03-12
2021-04-23
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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Cohort 1: BIIB054 Dose A
Participants will receive IV infusion of BIIB054 Dose A (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
BIIB054
Administered as specified in the treatment arm.
Cohort 2: BIIB054 Dose B
Participants will receive IV infusion of BIIB054 Dose B (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
BIIB054
Administered as specified in the treatment arm.
Cohort 3: BIIB054 Dose C
Participants will receive IV infusion of BIIB054 Dose C (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
BIIB054
Administered as specified in the treatment arm.
Cohorts 1-3: Placebo
Participants will receive a single IV infusion of BIIB054 matching placebo (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
Placebo
Administered as specified in the treatment arm.
Interventions
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BIIB054
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* Has not received levodopa or any other treatment for PD, herein referred to as symptomatic PD medication (including but, not limited to, dopamine agonists, amantadine, anticholinergics, monoamine oxidase type B (MAO-B) inhibitors, or safinamide) for at least 12 weeks prior to Day 1. Maximum total duration of prior PD regimens should not exceed 30 days.
* Score of less than equal to (\<=) 2.5 on the Modified Hoehn and Yahr Scale.
* Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reader).
Exclusion Criteria
* History of or positive test result at Screening for human immunodeficiency virus (HIV) or hepatitis C virus antibody (anti-HCV).
* Screening value for hemoglobin less than (\<)12 gram per deciliter (g/dL) for men or \<11 g/dL for women.
* Montreal Cognitive Assessment (MoCA) score \<23 or other significant cognitive impairment or clinical dementia.
* History of any brain surgery for PD.
* Participation in any passive or active immunotherapy targeting alpha-synuclein or other PD-related protein.
40 Years
80 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Toon-shi, Ehime, Japan
Research Site
Asahikawa-shi, Hokkaido, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Suita-shi, Osaka, Japan
Research Site
Bunkyō City, Tokyo-To, Japan
Research Site
Kodaira-shi, Tokyo-To, Japan
Countries
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Related Links
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Fox Trial Finder
Other Identifiers
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228PD103
Identifier Type: -
Identifier Source: org_study_id
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