Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006488
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-11-08
Brief Title:
Continuously Infused Intracerebral IC Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor r-metHuGDNF for the Treatment of Idiopathic Parkinsons Disease
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parkinsons 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 Parkinsons disease
The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of advanced Parkinsons disease The study will also test the delivery of GDNF using a catheter implanted into the putamen the area of the brain associated with Parkinsons 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 catheterinfusion pump system will also be assessed The study will last for 6 months Subjects will undergo neurological testing computerized gait assessment and neurological imaging
The purpose of this clinical trial is to determine whether GDNF works to relieve symptoms of advanced Parkinsons disease The study will also test the delivery of GDNF using a catheter implanted into the putamen the area of the brain associated with Parkinsons 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 catheterinfusion pump system will also be assessed The study will last for 6 months Subjects will undergo neurological testing computerized gait assessment and neurological imaging
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000096 | NIH | None | httpsreporternihgovquickSearchM01RR000096 |