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RESTORE-1 Clinical Study

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A Randomized, Placebo Surgery Controlled, Double-blinded, Multi‑center, Phase 2 Clinical Trial Evaluating the Efficacy and Safety of VY‑AADC02 in Parkinson’s Disease with Motor Fluctuations
PHASE

2

PATIENT POPULATION

Males and females,

40 to 75 years of age (inclusive)

CONDITION

Diagnosis of Parkinson’s disease, consistent with United Kingdom Brain Bank Criteria

Diagnosis of Parkinson’s disease ≥ 4 years

Unequivocal responsiveness to dopaminergic therapy

Stable Parkinson's features and symptoms for at least 4 weeks prior to screening evaluation

Study DRUGS

Experimental gene therapy (VY-AADC02)

—compared to—

Placebo surgical procedure

MEDICALPROFESSIONALS_CAPSID

OBJECTIVE

To assess the delivery and enzyme activity of VY‑AADC02 administered to the putamen, bilaterally, using stereotactic neurosurgery with MRI guidance

To assess the efficacy and safety of VY‑AADC02

Method of Administration

Infused bilaterally into the putamen during a one-time surgical procedure

Length of study participation

Approximately 21 study visits over 14 months, including 2 months of screening visits and 12 months of post‑surgical visits

Extension
study

Those who complete study participation have the option to take part in a long‑term extension for up to 8 years

Study Procedure, Follow-up, and Long-term Extension

Potential participants will be screened for study eligibility within the 60 days before Day 0 (the day of surgery). After treatment on Day 0, participants will be followed for 12 months. Patients will then be invited to participate in a long‑term extension study for up to an additional 8 years.

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