NCT06602193Active, not recruitingPhase 2
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
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)
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 16 Sept 2024
- Start date
- 24 Oct 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Denali Therapeutics Inc.
- Diseases
- Parkinson disease
- NCT number
- NCT06602193
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 24 Oct 2024 to the primary completion date, Mar 2027
- 20 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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 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
Other
- Have abnormal PFT results at screening
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Who the study is looking for
- 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.
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| University of Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| University Hospital Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Universitary Hospital La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| IDIVAL/University Hospital Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Movement Disorders Institute, Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel Aviv Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Parkinson's Disease and Movement Disorders Center Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Evergreen Health Laboratory Coordinator of this site? Confirm its status | Kirkland | United States | Unknown status |
| Cedars-Sinai Department of Neurology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Inland Northwest Research Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.