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This study evaluates AAV2-GDNF, a gene therapy, compared with a control surgical procedure in adults with moderate Parkinson's disease. It enrolls patients aged 45-75 who were diagnosed with Parkinson's disease in the past 4-10 years and respond to levodopa therapy. The study is in Phase 2 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
Age
1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
1. Presence of bradykinesia PLUS any of the following:
* Rigidity
* Rest tremor
* Postural instability
2. Presence of motor fluctuations as measured by the PD Motor Diary
3. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening
4. Must demonstrate responsiveness to levodopa therapy
Exclusion Criteria:
* Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
* Presence or history of significant vascular and/or cardiovascular disease
* Presence of significant cognitive impairment, poorly controlled depression/anxiety
* Presence or history of psychosis or impulse control disorder
* History of malignancy other than treated cutaneous squamous or basal cell carcinomas
* Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
* Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
* Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
* Chronic immunosuppressive therapy