Parkinson Disease Clinical Trial
Parkinson's disease is characterized by loss of neurons that produce dopamine in a region of
the brain called the substantia nigra. In the early stages of the disease, the disease
responds to agents that replace dopamine such as levodopa. Patients with more advanced
disease have wide fluctuations in their response to levodopa, exhibiting on and off periods.
This is due to continued degeneration of neurons. Recombinant-methionyl human glial cell
line-derived neurotrophic factor (r-metHuGDNF or GDNF) is a neurotrophic factor that
promotes survival of dopaminergic neurons. This is a protein produced by recombinant
technology that is almost identical to the naturally produced factor. Results of animal
studies indicate that GDNF has the potential to benefit patients with advanced Parkinson's
disease.
The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of
advanced Parkinson's disease. The study will also test the delivery of GDNF using a catheter
implanted into the putamen, the area of the brain associated with Parkinson's disease, and
an infusion pump that is implanted under the skin in the abdomen or chest. GDNF will be
placed into the pump and delivered through the catheter to the brain. The purposes of this
study are to determine the potential benefits and side effects of GDNF. The performance and
safety of the catheter/infusion pump system will also be assessed. The study will last for 6
months. Subjects will undergo neurological testing, computerized gait assessment and
neurological imaging.
n/a
Primary Purpose: Treatment
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