The purpose of this study is to determine whether CERE-120 is a safe and effective treatment for people with Parkinson’s disease (PD). http://www.ceregene.com/

CERE-120 is a gene transfer agent comprised of an adeno-associated virus (AAV2) carrying the gene for neurturin (NTN). NTN is a naturally occurring protein very similar to GDNF (Glial Derived Neurotrophic Factor) , whose role is to improve the health and function of degenerating dopamine-secreting neurons and to keep them alive and functioning normally. CERE-120 is administered during a neurosurgical procedure to the nigrostriatal region of the brain by bilateral stereotactic injections. This region, rich in dopamine-secreting neurons, degenerates in PD and this degeneration has been linked to the major motor deficits that characterize the disease.

The design of the study calls for approximately 34 participants to receive CERE-120 and approximately 17 participants to receive sham surgery (i.e., no CERE-120 will be administered). Neither the patient nor the patient’s neurologist will know whether treatment or sham surgery was given (i.e., this is a ‘double-blind trial design’). PD study assessment tests and safety tests will be performed on all participants throughout the course of the study. Participants in the trial will be followed for one year after the neurosurgical procedure. At the end of the study, the results from the two groups will be compared to determine if CERE-120 is a safe and effective treatment for PD. If at the end of the study, CERE-120 is shown to be safe and effective, the people who received the sham surgery will be offered treatment with CERE-120, as long as their neurologist and neurosurgeon deem them suitable for the surgical procedure. Less than half of the participants enrolled in this trial will undergo brain imaging by Positron Emission Tomography (PET) twice during the trial.

http://www.pdtrials.org/front/trial_...p?trial_id=128