Parkinson's Disease Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump.
This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.
Tremor, rigidity, slow movement, poor balance, and difficulty walking are characteristic
symptoms of Parkinson's disease (PD) that are associated with degeneration of
dopamine-producing nerve cells in the brain. Administration of growth factors that stimulate
neuronal stem and progenitor cells is one possible approach to restore the dopaminergic
activity. The drug product sNN0031 containing the endogenous growth factor PDGF has been
demonstrated to reduce the typical symptoms in animal models of PD.
NeuroNova intends to investigate whether intracerebroventricular administration of PDGF in
the form of the drug product sNN0031 can improve motor function in patients with PD. In this
first study the safety and tolerability of treatment for 2 weeks followed by 10 weeks
follow-up will be evaluated.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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