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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Apr 30, 2026 to Mar 2027
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 20 of 20 sites
    v16
  2. Study sites: 16 to 20v15
  3. Site contacts updated at 2 of 16 sitesv14
  4. Study sites: 15 to 16v13
  5. Study sites: 14 to 15v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 13 to 14v11
  2. Study sites: 12 to 13v10
  3. Study sites: 9 to 12v9
  4. Study sites: 8 to 9v8
  5. Study sites: 7 to 8v7
  6. Study sites: 5 to 7v6
  7. Study sites: 3 to 5v5
  8. Study sites: 2 to 3v4
  9. Study sites: 1 to 2v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 30, 2024 to Oct 24, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06602193
Lead Sponsor Denali Therapeutics Inc.
Collaborators: Biogen
Conditions
(from sponsor)		 Parkinson Disease
Related terms Movement Disorders, Parkinson Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov