This is a non-randomized, open label, dose-escalation study to evaluate the safety and efficacy of KL002 in the treatment of advanced primary Parkinson's disease. Condition or disease: Parkinson's Disease Intervention/treatment: Drug: KL002 Phase: NA
9 patients will be enrolled to this open-label dose escalation study to evaluate up to three dose levels of KL002 of three patients each. All patients will receive bilateral intraputaminal injections of KL002 through stereotactic brain surgery. The safety and potential clinical responses to KL002 will be assessed by clinical evaluations of Parkinson's disease, cognitive tests, laboratory blood tests and neuroimaging.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Neurosurgical delivery of KL002 to the brain
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Incidence of Treatment Emergent Adverse Events
Safety and Tolerability of KL002 assessed by Treatment Emergent Adverse Events
Time frame: Day 0 through month 24
Parkinson's Symptoms
Effect of KL002 on Parkinson's symptoms as recorded in subject diaries, neurological, motor, and non-motor assessments, quality of life surveys and changes to Parkinson's medications.
Time frame: Day 0 through month 24
PET Scan Imaging
Relationship between KL002 distribution in the brain and change in dopamine expression as indicated in PET imaging.
Time frame: Day 0 through month 24
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