Trials / Completed
CompletedNCT03562494
VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)
A Randomized, Sham Surgery Controlled, Double-blind, Multi-center, Phase 1 Clinical Trial, Evaluating the Safety of VY-AADC02 in Moderate to Advanced Parkinson's Disease Patients With Motor Fluctuations
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety of VY-AADC02 in participants with Parkinson's disease (PD) with motor fluctuations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VY-AADC02 | Adeno-associated viral vector serotype 2 encoding human aromatic L-amino acid decarboxylase (AAV2- hAADC) infusion into the brain |
| OTHER | Sham (Placebo) Surgery | Bilateral partial burr/twist holes without dura penetration |
Timeline
- Start date
- 2018-10-17
- Primary completion
- 2024-10-30
- Completion
- 2024-10-30
- First posted
- 2018-06-19
- Last updated
- 2024-12-10
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03562494. Inclusion in this directory is not an endorsement.