Conditions: Idiopathic Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).

Detailed description:

Arms:
arm 1: Intracerebral administration of CERE-120 arm 2: Sham Neurosurgery

Interventions: intervention 1: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) intervention 2: Sham Surgery
Intervention descriptions: intervention 1: CERE-120 5.4 x 10\^11 vg intervention 2: Bilateral partial thickness burr holes placed, no intraparenchymal injections

Protocol document: