Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
Public ClinicalTrials.gov record NCT03318523. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score. The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.
Study identification
- NCT ID
- NCT03318523
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 357 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 9, 2018
- Primary completion
- Oct 25, 2020
- Completion
- Apr 28, 2021
- Last update posted
- Feb 27, 2022
2018 – 2021
United States locations
- U.S. sites
- 32
- U.S. states
- 19
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| Research Site | La Jolla | California | 92093-0886 | — |
| Cedars Sinai | Los Angeles | California | 90048 | — |
| University of California San Francisco Medical Center | San Francisco | California | 94158 | — |
| Research Site | Stanford | California | 94305 | — |
| University of Colorado Health | Aurora | Colorado | 80045 | — |
| Rocky Mountain Movement Disorders Center, PC | Englewood | Colorado | 80113 | — |
| Parkinson's Disease and Movement Disorders Centerf | Boca Raton | Florida | 33486 | — |
| Mayo Clinic Hospital | Jacksonville | Florida | 32224 | — |
| Bioclinica Research | Orlando | Florida | 32806 | — |
| USF Health Byrd Institute | Tampa | Florida | 33616 | — |
| Northwestern University PD and Movement Disorders Center | Chicago | Illinois | 60611 | — |
| Research Site | Chicago | Illinois | 60612 | — |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | — |
| Ochsner Health System | New Orleans | Louisiana | 70121 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston University Medical Center | Boston | Massachusetts | 02118 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| NYU Langone Health Center | New York | New York | 10017 | — |
| Research Site | New York | New York | 10032 | — |
| Research Site | Durham | North Carolina | 27705 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44106 | — |
| Research Site | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Research Site | Nashville | Tennessee | 37232 | — |
| Research Site | Houston | Texas | 77030 | — |
| Booth Gardner Parkinson's Care Center at Evergreen Health | Kirkland | Washington | 98034 | — |
| Inland Northwest Research | Spokane | Washington | 99204 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03318523, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2022 · Synced Sep 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03318523 live on ClinicalTrials.gov.