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NCT05348785 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Parkinson Disease, sponsored by Biogen.

Active
Registry status
Phase 2
Development phase
650
Enrollment target
20
Study locations

NCT05348785 is a Phase 2 study of Parkinson Disease that is active but no longer recruiting, run by Biogen. The registered enrollment target is 650 participants, below the 5,324-participant average among 297 other Parkinson Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT05348785, a Phase 2 study of Parkinson Disease, is active but no longer recruiting, sponsored by Biogen.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
650 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Parkinson Disease

Interventions

  • DRUG BIIB122
  • DRUG BIIB122-Matching Placebo

Study Locations (20)

California

  • University of Southern California - Los Angeles
  • Cedars Sinai - Los Angeles
  • SC3 Research Group Inc. - Pasadena
  • University of California San Francisco (UCSF) - San Francisco

Florida

  • Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
  • University of Miami - Miami
  • Adventist Health System/Sunbelt, Inc. - Orlando
  • USF Health Byrd Institute - Tampa

Massachusetts

  • Boston University Medical Center - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Massachusetts General Hospital - Boston

Arizona

  • Mayo Clinic Arizona - Phoenix
  • Banner Sun Health Research Institute - Sun City

Colorado

  • University of Colorado - Aurora
  • CenExel Rocky Mountain Clinical Research - Englewood

Illinois

  • Northwestern University - Chicago
  • Rush University Medical Center - Chicago

Connecticut

  • Invicro - New Haven

Hawaii

  • Hawaii Pacific Neuroscience, LLC - Honolulu

Trial Details

FieldValue
Enrollment Target 650 participants
Start Date 2022-04-19
Est. Completion 2026-03-09
Phase Phase 2

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05348785

The ClinicalTrials.gov registry entry for NCT05348785 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 650 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,324-participant average among 297 other Parkinson Disease trials with a reported enrollment target (88% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which BIIB122 is the first listed.

NCT05348785 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05348785 about?

NCT05348785 is a clinical study titled "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". 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 o...

What is the current status of trial NCT05348785?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 650 participants. The study started on 2022-04-19. Estimated completion is 2026-03-09.

What conditions does trial NCT05348785 study?

This clinical trial studies the following conditions: Parkinson Disease.

What interventions are being tested in trial NCT05348785?

The interventions under investigation include: BIIB122 (DRUG), BIIB122-Matching Placebo (DRUG).

Who is sponsoring clinical trial NCT05348785?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05348785 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.