Trials / Completed
CompletedNCT00985517
Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease
A Phase 1/2 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 Parkinson's Disease
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Sangamo Therapeutics · Industry
- Sex
- All
- Age
- 35 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the safety and potential benefits of CERE-120 in the treatment of Parkinson's 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 Parkinson's 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 Parkinson's disease received CERE-120 at one of two dose levels. In the second part of the study (Phase 2), subjects were randomized 1:1 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CERE-120: Adeno-Associated Virus Delivery of Neurturin | |
| PROCEDURE | Sham Surgery |
Timeline
- Start date
- 2009-10-29
- Primary completion
- 2014-11-09
- Completion
- 2017-11-16
- First posted
- 2009-09-28
- Last updated
- 2020-04-16
- Results posted
- 2020-03-26
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00985517. Inclusion in this directory is not an endorsement.