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NCT00006488 · ClinicalTrials.gov registry record · Phase 1
Continuously Infused Intracerebral (IC) Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) for the Treatment of Idiopathic Parkinson's Disease
A Phase 1 study, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- Phase 1
- Development phase
NCT00006488 is a Phase 1 study that has completed, run by National Center for Research Resources (NCRR).
The verdict
NCT00006488, a Phase 1 study, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
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.
Interventions
- DRUG recombinant-methionyl human glial cell line-derived neurotrophic factor
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006488
The ClinicalTrials.gov registry entry for NCT00006488 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which recombinant-methionyl human glial cell line-derived neurotrophic factor is the first listed.
NCT00006488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006488 about?
NCT00006488 is a clinical study titled "Continuously Infused Intracerebral (IC) Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) for the Treatment of Idiopathic Parkinson's Disease". 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...
What is the current status of trial NCT00006488?
This trial is currently completed. It is a Phase 1 study.
What interventions are being tested in trial NCT00006488?
The interventions under investigation include: recombinant-methionyl human glial cell line-derived neurotrophic factor (DRUG).
Who is sponsoring clinical trial NCT00006488?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.
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