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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

Must not have

History of malignancy other than treated carcinoma in situ within 3 years of screening evaluation

Severe, biphasic and/or uncontrolled dyskinesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 360

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had cancer, other than a treated surface-level carcinoma, in the last 3 years.

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I experience severe and uncontrollable muscle movements.

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My cognitive test score is below 26.

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I haven't been part of any research studies or taken experimental treatments in the last 2 months.

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I have brain imaging abnormalities that make surgery risky.

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I cannot have MRI scans or use gadolinium contrast due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 360

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 360

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 360 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 study objectives

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