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Phase 2 Safety and Efficacy Study Evaluating Glutamic Acid Decarboxylase Gene Transfer to Subthalamic Nuclei in Subjects With Advanced Parkinson's Disease

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Trial Profile

Phase 2 Safety and Efficacy Study Evaluating Glutamic Acid Decarboxylase Gene Transfer to Subthalamic Nuclei in Subjects With Advanced Parkinson's Disease

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2025

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At a glance

  • Drugs NLX P101 (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Neurologix

Most Recent Events

  • 19 Aug 2025 According to a MeiraGTx media release, This RMAT was awarded following the presentation to the FDA of positive data from 3 clinical studies demonstrating the benefit of AAV-GAD when administered in a one-time stereotactic infusion to the subthalamic nucleus in the brain, Phase 1 dose escalation study (n=14), double-blind sham-surgery controlled Phase 2 study (n=45) and double-blind sham-surgery controlled Phase 1/2 clinical bridging study (n=14).
  • 12 Dec 2018 Results presented in a MeiraGTx media release.
  • 12 Dec 2018 According to a MeiraGTx media release, results from this study were published in the 2018 issue of Science Translational Medicine.

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