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

Description

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.

Conditions

Parkinson Disease

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Parkinson Disease
Intervention / Treatment

-

Contacts and Locations

Boca Raton

Parkinson's Disease and Movement Disorders Center, Boca Raton, Florida, United States, 33486

Spokane

Inland Northwest Research, Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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

Ages Eligible for Study

30 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Denali Therapeutics Inc.,

Danna Jennings, MD, STUDY_DIRECTOR, Denali Therapeutics

Study Record Dates

2028-02-28