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Virus Therapy

VY-AADC02 for Parkinson's Disease

Phase 1

Waitlist Available

Research Sponsored by Neurocrine Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Motor responsiveness to dopaminergic therapy, demonstrated by improvement in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS III score)

An average of ≥3 hours of OFF time per day over 3 consecutive days as confirmed by the PD Diary

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years after surgery

Awards & highlights

Study Summary

This trial is testing a new medication for people with Parkinson's disease who have trouble with their medication working consistently.

Who is the study for?

This trial is for people aged 40-75 with Parkinson's Disease diagnosed at least 4 years ago, experiencing poor motor control for over 3 hours daily. They must respond to Parkinson's medication and not have had brain surgery or plan to during the study. Individuals with psychiatric conditions, certain brain imaging abnormalities, or recent cancer are excluded.Check my eligibility

What is being tested?

The RESTORE-1 trial is testing VY-AADC02 against a sham (placebo) surgery in individuals with Parkinson’s Disease who experience significant fluctuations in their motor abilities. The goal is to evaluate the safety of this new potential treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks may include those associated with surgical procedures such as infection, bleeding, and reactions to anesthesia; plus any unique risks from the gene therapy used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's symptoms improve with dopamine therapy.

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I experience at least 3 hours of worsened symptoms daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Change in MDS-UPDRS II score

Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III score in the OFF state

Other outcome measures

Safety outcome measured by treatment emergent adverse events (TEAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory analysis, and immunogenicity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VY-AADC02 (NBIb-1817)Experimental Treatment1 Intervention

Single administration of up to 3.6 x 10^12 vector genomes (vg) of VY-AADC02

Group II: Sham (Placebo) SurgeryPlacebo Group1 Intervention

Sham surgical procedure

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor

75 Previous Clinical Trials

6,737 Total Patients Enrolled

Voyager TherapeuticsIndustry Sponsor

4 Previous Clinical Trials

45 Total Patients Enrolled

Grace Liang, MDStudy DirectorNeurocrocrine Biosciences

1 Previous Clinical Trials

14 Total Patients Enrolled

Media Library

VY-AADC02 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03562494 — Phase 1

Parkinson's Disease Research Study Groups: Sham (Placebo) Surgery, VY-AADC02 (NBIb-1817)

Parkinson's Disease Clinical Trial 2023: VY-AADC02 Highlights & Side Effects. Trial Name: NCT03562494 — Phase 1

VY-AADC02 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03562494 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could adults over 20 years of age partake in this clinical trial?

"This trial seeks participants aged between 40 to 75 years old. There are 27 studies currently recruiting those under 18 and 480 trials that target the elderly population."

Answered by AI

How many medical centers are administering this clinical trial?

"Twenty medical centres are associated with this clinical trial, including NYU Langone Medical Center in New york City, Hackensack University Medical Centre in Hackensack, and Northwestern Medical Faculty Foundation. Additionally there are 17 other participating locations."

Answered by AI

Is VY-AADC02 recognized by the Food and Drug Administration?

"Our team at Power gave VY-AADC02 a safety rating of 2 since it is in Phase 2, indicating that the drug has been proven safe but not yet found to be effective."

Answered by AI

Has recruitment for this trial opened up yet?

"As indicated on clinicaltrials.gov, this medical research is currently not enrolling participants; however, the trial was first posted in 2018 and most recently updated earlier this year. Currently there are 483 other trials recruiting patients across a variety of different conditions."

Answered by AI

Is there a possibility for me to participate in this medical experiment?

"The criteria for participation in this clinical trial includes a diagnosis of Parkinson's disease and an age between 40-75 years old. Currently, 85 patients are being recruited to the study."

Answered by AI