A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80 (LUMA)

  • STATUS
    Recruiting
  • End date
    Aug 28, 2025
  • participants needed
    640
  • sponsor
    Biogen
Updated on 17 November 2022
movement disorder
hoehn and yahr scale

Summary

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study:
  • Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it.
  • Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks.
  • Certain medications for PD will be allowed at enrollment for a subset of participants.
  • The majority of clinic visits will be every 12 weeks. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD.
To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122.

Description

BIIB122 is an investigational central nervous system-penetrant small molecule inhibitor of LRRK2 kinase.

Details
Condition Parkinson Disease, parkinson's disease, Parkinson's Disease
Treatment BIIB122, BIIB122-Matching Placebo
Clinical Study IdentifierNCT05348785
SponsorBiogen
Last Modified on17 November 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis
Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at screening
MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal to (≤)40 at screening
Screening genetic test results verifying the absence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants

Exclusion Criteria

Clinically significant neurological disorder other than PD, including but not limited to stroke, dementia, or seizure, within 5 years of screening visit, in the opinion of the Investigator
Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism
Montreal Cognitive Assessment (MoCA) score <24 at the screening visit
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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