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NCT01621581 · ClinicalTrials.gov registry record · Phase 1
AAV2-GDNF for Advanced Parkinson s Disease
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01621581 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 25 participants.
The verdict
NCT01621581, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Background: \- Glial cell line-derived neurotrophic factor (GDNF) is a chemical that may help protect and strengthen brain cells that produce dopamine. Dopamine is a chemical that affects brain function. People with Parkinson's disease (PD) have problems producing dopamine in the brain. Researchers want to see if gene transfer can help deliver GDNF into the area of the brain that is damaged by PD. The gene transferred in this study, called AAV2-GDNF, may help produce GDNF to protect the damaged brain cells. Objectives: \- To test the safety and effectiveness of AAV2-GDNF gene transfer for advanced PD. Eligibility: \- Individuals at least 18 years of age who have advanced PD that is not well controlled by medications. Design: * Participants will be in the study for about 5 years. There will be 18 outpatient study visits and a 3-day stay in the hospital. There may also be overnight stays for followup visits. * Participants will be screened with a physical exam and medical history. Blood samples will be collected. Tests of PD symptoms and mood and memory will be given. Imaging studies will be used to find the right part of the brain to infuse the gene. The screening visit will take place up to 60 days before surgery. * Participants will have a baseline visit about a month before the surgery. For 1 week before the baseline visit, participants will keep a diary on any motor problems. The visit will involve movement tests given before and after taking a regular dose of levodopa. * Participants will have surgery to infuse AAV2-GDNF into the brain. The surgery will also include a lumbar puncture (spinal tap) to collect cerebrospinal fluid. After surgery, participants will recover in the hospital for at least 2 days. * Participants will have another lumbar puncture 6 and 18 months after surgery. This will be an outpatient visit. * Participants will have regular followup visits after the surgery. These visits will include neurological tests and movement studies. Visits
Interventions
- GENETIC Convection enhanced delivery/AAV2-GDNF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-03-13 |
| Est. Completion | 2022-02-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01621581
The ClinicalTrials.gov registry entry for NCT01621581 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Convection enhanced delivery/AAV2-GDNF is the first listed.
NCT01621581 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01621581 about?
NCT01621581 is a clinical study titled "AAV2-GDNF for Advanced Parkinson s Disease". Background: \- Glial cell line-derived neurotrophic factor (GDNF) is a chemical that may help protect and strengthen brain cells that produce dopamine. Dopamine is a chemical that affects brain function. People with Parkinson's disease (PD) have problems producing dopamine in the brain. Researchers...
What is the current status of trial NCT01621581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-03-13. Estimated completion is 2022-02-04.
What interventions are being tested in trial NCT01621581?
The interventions under investigation include: Convection enhanced delivery/AAV2-GDNF (GENETIC).
Who is sponsoring clinical trial NCT01621581?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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