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NCT06602193

Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

Active, Not Recruiting
PHASE2Ages 30+InterventionalTreatment
Denali Therapeutics Inc.
~50 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:BIIB122 225 mgBIIB122-Matching Placebo

At a glance

Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
Measured over 12 weeks

Conditions

Parkinson Disease

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NCT06602193

Where you'd take part

This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsno site contact published

  • Cedars-Sinai Department of Neurology

    Los Angeles, Californiano site contact published

  • Evergreen Health Laboratory

    Kirkland, Washingtonno site contact published

  • Hospital Clinic de Barcelona

    Barcelona, Spainno site contact published

  • Hospital Universitari General de Catalunya

    Barcelona, Spainno site contact published

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spainno site contact published

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Spainno site contact published

  • Hospital Universitario Virgen del Rocio

    Seville, Spainno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Danna Jennings, MD · STUDY_DIRECTOR · Denali Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.

Exclusion

Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.
Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).
Have previously participated or are currently participating in a gene therapy study for PD.
Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).
Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).
Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature
Have abnormal PFT results at screening

What this trial measures

  • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period12 weeks