A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (LIGHTHOUSE)

  • STATUS
    Recruiting
  • End date
    Jan 15, 2031
  • participants needed
    400
  • sponsor
    Biogen
Updated on 16 November 2022
depression
motor symptoms
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). The study will focus on participants with a specific genetic variant in their LRRK2 gene.
The main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD 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.
  • The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms.
  • The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms.
  • Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety.
  • Part II measures motor experiences of daily living.
  • Part III is the results of a motor symptoms exam by a medical professional.
  • Part IV records PD complications caused by motor symptoms.
Researchers will also learn more about the safety of BIIB122.
A description of how the study will be done is given below.
  • Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine.
  • Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods.
  • Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks.
  • Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins.
  • Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.

Description

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

To learn more about the study and find out if you are eligible, click here:  together4pd.com
 

Details
Condition Parkinson Disease, parkinson's disease, Parkinson's Disease
Treatment BIIB122, BIIB122-Matching Placebo
Clinical Study IdentifierNCT05418673
SponsorBiogen
Last Modified on16 November 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 5 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 2.5 (in OFF state), inclusive, at Screening
MDS-UPDRS Parts II and III (in OFF state) combined score ≤40 at Screening
Screening genetic test results verifying the presence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant

Exclusion Criteria

Clinically significant neurologic 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Step 1 Connect with a study center
What happens next?
  • 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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