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Monoclonal Antibodies

BIIB122 for Parkinson's Disease (LIGHTHOUSE Trial)

Phase 3

Waitlist Available

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up aes: day 1 up to week 187; saes: screening up to week 187

Awards & highlights

LIGHTHOUSE Trial Summary

This trial is studying a drug called BIIB122 in people with early-stage Parkinson's disease. The focus is on people with a specific genetic variant in their LRRK2 gene. The aim is to see if taking BIIB122 slows the worsening of PD more than placebo.

LIGHTHOUSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ aes: day 1 up to week 187; saes: screening up to week 187

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~aes: day 1 up to week 187; saes: screening up to week 187

This trial's timeline: 3 weeks for screening, Varies for treatment, and aes: day 1 up to week 187; saes: screening up to week 187 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Over the Treatment Period

Secondary outcome measures

Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score

Change From Baseline in MDS-UPDRS Parts II and III Combined Score

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

+2 more

LIGHTHOUSE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BIIB122 225 mgExperimental Treatment1 Intervention

Participants will receive 225 mg of BIIB122 tablets, orally, once daily (QD) for up to 180 weeks.

Group II: BIIB122-Matching PlaceboPlacebo Group1 Intervention

Participants will receive BIIB122-matching placebo tablets, orally, QD for up to 180 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BIIB122

2022

Completed Phase 1

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Denali Therapeutics Inc.Industry Sponsor

22 Previous Clinical Trials

1,860 Total Patients Enrolled

BiogenLead Sponsor

639 Previous Clinical Trials

467,429 Total Patients Enrolled

Medical DirectorStudy DirectorBiogen

2,777 Previous Clinical Trials

8,063,473 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively looking for volunteers for this experiment?

"Yes, this trial is still open and according to the updated information on clinicaltrials.gov, was last updated on 10/31/2022."

Answered by AI

Does this experimental treatment program allow seniors as participants?

"The age parameters for this particular study are much more limited than other research trials, as patients must be between 30 and 80 years old to enroll. In contrast, there are 511 other trials welcoming patients that are over 65 and 29 that permit people under the age of 18."

Answered by AI

Are there potential risks associated with BIIB122?

"BIIB122 ranks as a 3 on our safety scale at Power, as it is a Phase 3 trial. This means that, while there is efficacy data supporting the use of the medication, there are also multiple rounds of data that suggest it is safe."

Answered by AI

How many patients are allowed to enroll in this experiment?

"The correct answer is that this clinical trial is currently recruiting patients. This can be seen by looking at the date of the most recent update on clinicaltrials.gov, which was 10/31/2022. The study is looking for 400 participants at 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05418673.