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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.
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

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Technische Universität Dresden
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DresdenGermanyUnknown status
University of Lübeck
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LübeckGermanyUnknown status
University Hospital Tübingen
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TübingenGermanyUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitari General de Catalunya
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitario Donostia
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Donostia / San SebastianSpainUnknown status
Universitary Hospital La Princesa
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MadridSpainUnknown status
IDIVAL/University Hospital Marques de Valdecilla
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SantanderSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Movement Disorders Institute, Sheba Medical Center
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Ramat GanIsraelUnknown status
Tel Aviv Medical Center
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Tel AvivIsraelUnknown status
Parkinson's Disease and Movement Disorders Center
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Boca RatonUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
Evergreen Health Laboratory
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KirklandUnited StatesUnknown status
Cedars-Sinai Department of Neurology
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Los AngelesUnited StatesUnknown status
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
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New YorkUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Inland Northwest Research
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SpokaneUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.