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A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)

StatusNot Yet Recruiting
PhasePhase 2
SponsorBayer
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 15, 2028 → Jun 15, 2029
See other at-risk trials from Bayer

Record History

  1. Notable Primary completion pushed from Dec 15, 2028 to Jun 15, 2029 Start date: Jul 27, 2026 to Jan 25, 2027 · Completion pushed from Jun 15, 2032 to Dec 15, 2032 · Site details revised at 1 of 6 sitesv3 Show 3 more changesShow less
    • Start date: Jul 27, 2026 to Jan 25, 2027
    • Completion pushed from Jun 15, 2032 to Dec 15, 2032
    • Site details revised at 1 of 6 sites
  2. Minor Eligibility criteria shortened, about 2 words Study title expanded, about 1 wordv2 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
131 trials monitored
See 7 trials at risk
The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).
Trial Details
NCT Number NCT07566429
Lead Sponsor Bayer
Collaborators: AskBio Inc
Conditions Parkinson Disease
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov