A Phase 2, Randomized, Double-blind, Sham Surgery-controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults With Moderate Stage Parkinson's Disease

Trial ID: NCT06285643

Interventional - Phase 2 - Active, not recruiting

The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.

Conditions

• Parkinson Disease

Interventions

• AAV2-GDNF gene therapy
• control surgery

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

Sponsor

AskBio Inc, Bayer

Source: ClinicalTrials.gov

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