Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252850
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2005-11-11
Brief Title:
Safety of CERE-120 AAV2-NTN in Subjects With Idiopathic Parkinsons Disease
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
A Phase I Open-Label Study of CERE-120 Adeno-Associated Virus Serotype 2 AAV2-NeurturinNTN to Assess the Safety and Tolerability of Intrastriatal Delivery to Subjects With Idiopathic Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2016-09
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:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None