Ignite Creation Date:
2024-05-05 @ 9:52 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00985517
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2009-09-25
Brief Title:
Safety and Efficacy of CERE-120 in Subjects With Parkinsons Disease
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
A Phase 12 Trial Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 Adeno-Associated Virus Serotype 2 AAV2-Neurturin NTN in Subjects With Idiopathic Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2020-04
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:
The purpose of this study was to evaluate the safety and potential benefits of CERE-120 in the treatment of Parkinsons disease
Detailed Description:
CERE-120 is an experimental drug that consists of an adeno-associated virus AAV that was engineered to carry the human gene for neurturin a neurotrophic growth factor Similar to other growth factors such as GDNF neurturin is capable of restoring function and protecting brain cells from further damage The virus used in CERE-120 is not known to cause disease in people
CERE-120 is delivered directly to the brain cells most affected in Parkinsons disease - the dopamine producing neurons CERE-120 is injected during brain surgery Once in place CERE-120 continuously produces neurturin
During the first open-label part of the study Phase 1 subjects with Parkinsons disease received CERE-120 at one of two dose levels In the second part of the study Phase 2 subjects were randomized 11 to receive CERE-120 or a sham surgery where no medication was injected
Participants in both phases of the study were followed for up to five years after surgery
CERE-120 is delivered directly to the brain cells most affected in Parkinsons disease - the dopamine producing neurons CERE-120 is injected during brain surgery Once in place CERE-120 continuously produces neurturin
During the first open-label part of the study Phase 1 subjects with Parkinsons disease received CERE-120 at one of two dose levels In the second part of the study Phase 2 subjects were randomized 11 to receive CERE-120 or a sham surgery where no medication was injected
Participants in both phases of the study were followed for up to five years after surgery
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