An Observational, Long-Term Extension Study for Participants in Prior VY-AADC01 Clinical Studies

Neurocrine Biosciences3 sites in 1 country14 target enrollmentAugust 24, 2018

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Neurocrine Biosciences
Enrollment: 14
Locations: 3
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Status: Completed
Last Updated: 2 years ago

An extension study for participants who have completed a prior VY-AADC01 clinical study

Registry

clinicaltrials.gov

Start Date

August 24, 2018

End Date

July 18, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•Completed participation in the PD-1101 or PD-1102 clinical study of VY-AADC01 gene therapy

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Time Frame: Up to 8 years from VY-AADC01 administration

Long-term safety of VY-AADC01 as measured by Adverse Events and Serious Adverse Events

Changes in PD medications(Up to 8 years from VY-AADC01 administration)
Changes in "Off" and "On" time as recorded by the participant in Parkinson's Disease (PD) diary(Up to 8 years from VY-AADC01 administration)
Change in AADC enzyme activity(Up to 8 years from VY-AADC01 administration)
Changes in motor function as assessed by Unified Parkinson's Disease Rating Scale (UPDRS)(Up to 8 years from VY-AADC01 administration)