Idiopathic Parkinson's Disease Clinical Trial
Official title:
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
The purpose of this study was to evaluate the safety and potential benefits of CERE-120 in the treatment of Parkinson's disease.
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.
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