A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80
Public ClinicalTrials.gov record NCT05348785. 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 Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study. The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms. The main question researchers want to answer is: \- How long does it take for PD symptoms to worsen during BIIB122 treatment? Researchers will answer this and other questions by measuring the symptoms of PD over time using a variety of scoring tools. These include the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the modified Schwab and England Activities of Daily Living Scale (mSE-ADL). The MDS-UPDRS is used to measure symptoms of PD. It has 4 parts: Part I, II, III, and IV. Each part measures different aspects of motor and non-motor symptoms. The mSE-ADL measures a participant's ability to perform daily activities or personal chores. Researchers will also learn more about the safety of BIIB122. They will check participants for adverse events. Adverse events are unwanted health problems that may or may not be caused by the study drug. The study will be done as follows: * Participants will be randomly assigned to take either BIIBB122 or placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know if the participants are receiving BIIB122 or placebo. * Participants will take BIIB122 or placebo tablets by mouth once a day. * The treatment period for each participant will last between 48 and 144 weeks. * There will be a safety follow-up period for 2 weeks after the last dose of BIIB122. * In total, participants will have up to 29 study visits. * Participants will stay in the study for at least 1 year, up to about 3 years.
Study identification
- NCT ID
- NCT05348785
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 650 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 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
- Apr 19, 2022 (Actual)
- Primary completion
- Mar 9, 2026 (Actual)
- Completion
- Mar 9, 2026 (Actual)
- Last update posted
- Jun 4, 2026
2022 – 2026
United States locations
- U.S. sites
- 33
- U.S. states
- 19
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Cedars Sinai | Los Angeles | California | 90048 | — |
| SC3 Research Group Inc. | Pasadena | California | 91105 | — |
| University of California San Francisco (UCSF) | San Francisco | California | 94143 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| CenExel Rocky Mountain Clinical Research | Englewood | Colorado | 80113 | — |
| Invicro | New Haven | Connecticut | 06510 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Adventist Health System/Sunbelt, Inc. | Orlando | Florida | 32803 | — |
| USF Health Byrd Institute | Tampa | Florida | 33613 | — |
| Hawaii Pacific Neuroscience, LLC | Honolulu | Hawaii | 96817 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | — |
| Boston University Medical Center | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02421 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Weill Medical College of Cornell University | New York | New York | 10021 | — |
| Duke Movement Disorders Clinic | Durham | North Carolina | 27705 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| UPHS | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Neurology Clinic, PC | Cordova | Tennessee | 38018 | — |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | — |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | — |
| Virginia Commonwealth University Department of Neurology | Richmond | Virginia | 23298 | — |
| Evergreen Hospital Medical Center | Kirkland | Washington | 98034 | — |
| Inland Northwest Research | Spokane | Washington | 99202 | — |
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 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05348785, 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 Jun 4, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05348785 live on ClinicalTrials.gov.