A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants

Last updated: October 6, 2023
Sponsor: MeiraGTx, LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Parkinson's Disease

Treatment

Sham Surgery

AAV-GAD Dose 1

AAV-GAD Dose 2

Clinical Study ID

NCT05603312
  • Ages 25-85
  • All Genders

Study Summary

The objective of this clinical trial is to evaluate the safety and tolerability of adeno-associated virus (AAV)-mediated delivery of glutamic acid decarboxylase (GAD) gene transfer into the subthalamic nuclei (STN) of participants with Parkinson's Disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed Parkinson's Disease
  • Levodopa responsiveness for at least 12 months
  • UPDRS Part 3 score of ≥25 points in the "off" state

Exclusion

Exclusion Criteria:

  • Past history of brain surgery to treat Parkinson's Disease
  • Any history of cerebral insult or central nervous system infection
  • Atypical Parkinson's Disease
  • Focal or lateralized neurologic deficits
  • Evidence of significant medical or psychiatric disorders
  • Cognitive impairment as defined by Montreal Cognitive Assessment (MoCA)≤20
  • Beck Depression Inventory-II score of ≥ 20

Study Design

Total Participants: 14
Treatment Group(s): 3
Primary Treatment: Sham Surgery
Phase: 1/2
Study Start date:
October 05, 2022
Estimated Completion Date:
March 01, 2024

Study Description

The planned length of participation in the study for each participant will be approximately 7 months. This includes a screening period of up to 40 days, randomization and surgery, and a follow-up period of 26 weeks.

Connect with a study center

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan 48322
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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