Summary

Eligibility
for people ages 30 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Marta San Luciano Palenzuela, MD (ucsf)
Headshot of Marta San Luciano Palenzuela
Marta San Luciano Palenzuela

Description

Summary

This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.

Official Title

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

Keywords

Parkinson Disease, LRRK2, Movement Disorders, BIIB122 225 mg

Eligibility

You can join if…

Open to people ages 30 years and up

  • 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.

You CAN'T join if...

  • 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • Evergreen Health Laboratory accepting new patients
    Kirkland Washington 98034 United States

Lead Scientist at University of California Health

  • Marta San Luciano Palenzuela, MD (ucsf)
    Dr. Marta San Luciano specializes in diagnosing and managing movement disorders, including Parkinson's disease, dystonia, tremor and myoclonus, in both children and adults.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Denali Therapeutics Inc.
ID
NCT06602193
Phase
Phase 2 Parkinson's Disease Research Study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated