New medication slows disease progression
- Trial ID
- NCT06602193
- 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)
- Goal
- New medication slows disease progression
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Denali Therapeutics Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson Disease
- Interventions
- BIIB122 225 mg, BIIB122-Matching Placebo
Plain-Language Summary
The goal is to see whether BIIB122 can safely dial down overactive LRRK2 kinase activity, the molecular driver of cell stress in people with LRRK2-linked Parkinson's, and produce pharmacodynamic changes that suggest it might slow harmful disease processes. BIIB122 is an oral LRRK2 inhibitor designed to lower that enzyme’s activity in the body, it is being tested alongside participants' usual Parkinson's medicines rather than replacing levodopa, and the study carefully watches safety and any effects on standard treatments. They plan to enroll about 50 adults with genetically confirmed pathogenic LRRK2 variants who meet clinical Parkinson's criteria, generally ages 30 to 80 for heterozygous carriers and 30 or older for homozygous carriers, excluding people with other major neurological disorders, prior PD gene therapy or brain surgery, or serious lung or vital-sign abnormalities.
Locations
- Cedars-Sinai Department of Neurology, Los Angeles, California, United States
- University of California San Francisco, San Francisco, California, United States
- Parkinson's Disease and Movement Disorders Center, Boca Raton, Florida, United States
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
- Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center, New York, New York, United States
- Evergreen Health Laboratory, Kirkland, Washington, United States
- Inland Northwest Research, Spokane, Washington, United States
- Technische Universität Dresden, Dresden, Germany
- University of Lübeck, Lübeck, Germany
- University Hospital Tübingen, Tübingen, Germany
- Rabin Medical Center, Petah Tikva, Israel
- Movement Disorders Institute, Sheba Medical Center, Ramat Gan, Israel
- Tel Aviv Medical Center, Tel Aviv, Israel
- Hospital Clinic de Barcelona, Barcelona, Spain
- Hospital Universitari General de Catalunya, Barcelona, Spain
- Hospital Universitari Vall d'Hebron, Barcelona, Spain
- Hospital Universitario Donostia, Donostia / San Sebastian, Spain
- Universitary Hospital La Princesa, Madrid, Spain
- IDIVAL/University Hospital Marques de Valdecilla, Santander, Spain
- Hospital Universitario Virgen del Rocio, Seville, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying BIIB122 225 mg. The goal is to see whether BIIB122 can safely dial down overactive LRRK2 kinase activity, the molecular driver of cell stress in people with LRRK2-linked Parkinson's, and produce pharmacodynamic changes that suggest it might slow harmful disease processes. BIIB122 is an oral LRRK2 inhibitor designed to lower that enzyme’s activity in the body, it is being tested alongside participants' usual Parkinson's medicines rather than replacing levodopa, and the study carefully watches safety and any effects on standard treatments. They plan to enroll about 50 adults with genetically confirmed pathogenic LRRK2 variants who meet clinical Parkinson's criteria, generally ages 30 to 80 for heterozygous carriers and 30 or older for homozygous carriers, excluding people with other major neurological disorders, prior PD gene therapy or brain surgery, or serious lung or vital-sign abnormalities.
- Who can participate?
- Participants must be at least 30 Years.
- Where is this trial located?
- This trial is recruiting at 20 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year and 6 months.