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A Phase Ib/II Randomized, Double-Blind Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT 130) in Early Manifest Huntington's Disease

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Trial Profile

A Phase Ib/II Randomized, Double-Blind Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT 130) in Early Manifest Huntington's Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 May 2024

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At a glance

  • Drugs AMT-130 (Primary)
  • Indications Huntington's disease
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors uniQure
  • Most Recent Events

    • 10 May 2024 This trial has been discontinued in Germany.
    • 07 May 2024 According to an uniQure media release, enrollment in third cohort is expected to be completed in the second half of 2024.
    • 07 May 2024 According to an uniQure media release, the Company is on track to initiate interactions with the U.S. Food and Drug Administration in the second quarter of 2024 for the discussions of the interim data from the ongoing Phase I/II clinical trials.
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