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NCT00252850 · ClinicalTrials.gov registry record · Phase 1
Safety of CERE-120 (AAV2-NTN) in Subjects With Idiopathic Parkinson's Disease
A Phase 1 study, sponsored by Sangamo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00252850 is a Phase 1 study that has completed, run by Sangamo Therapeutics. The registered enrollment target is 12 participants.
The verdict
NCT00252850, a Phase 1 study, has completed, sponsored by Sangamo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a Phase I dose escalating open-label study designed to assess the safety, tolerability and biologic activity of an in vivo AAV2 mediated delivery of the gene encoding NTN (CERE-120). Twelve (up to 18) subjects will receive one of two open-label doses of CERE-120 via bilateral stereotactic injections targeting the putaminal region of the brain. Subjects will be enrolled in one of two cohorts, a low-dose cohort of six subjects followed by a high dose cohort of six subjects. The design of this study is such that the primary objective, the evaluation of safety and tolerability, will be assessed by frequent observations for adverse events, clinical laboratory test results, imaging (MRI), neuropsychometric testing, and evaluations of disease status.
Interventions
- GENETIC CERE-120: AAV2-NTN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00252850
The ClinicalTrials.gov registry entry for NCT00252850 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sangamo Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CERE-120: AAV2-NTN is the first listed.
NCT00252850 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00252850 about?
NCT00252850 is a clinical study titled "Safety of CERE-120 (AAV2-NTN) in Subjects With Idiopathic Parkinson's Disease". This is a Phase I dose escalating open-label study designed to assess the safety, tolerability and biologic activity of an in vivo AAV2 mediated delivery of the gene encoding NTN (CERE-120). Twelve (up to 18) subjects will receive one of two open-label doses of CERE-120 via bilateral stereotactic i...
What is the current status of trial NCT00252850?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2005-06. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00252850?
The interventions under investigation include: CERE-120: AAV2-NTN (GENETIC).
Who is sponsoring clinical trial NCT00252850?
This trial is sponsored by Sangamo Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
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