Tolerability and Efficacy of Spheramine will be evaluated after operative implantation (Stereotactic Intrastriatal Implantation) in patients with advanced Parkinson's Disease
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Stereotactic Intrastriatal Implantation
Unnamed facility
Atlanta, Georgia, United States
The primary outcome measure for evaluating efficacy will be the motor subscore of the Unified Parkinson's Disease Rating Scale (UPDRS) (version 3.0) in the practically defined "off" state. During the Screening and at Baseline Evaluations.
Time frame: Evaluations, and at approximately 1, 3, 6, 9, 12, 15, 18 and 24 months post-implantation and annually thereafter, the patients Parkinson's symptomatology will be evaluated both on their baseline drug therapy and in the practically defined "off" period.
Involuntary Movements, time Motor Tests
Time frame: Performed during defined "off" and best "on" states
Motor Fluctuation and Percent OFF Time Evaluation
Time frame: Daily "on" phases, "off" phases and hours of sleep per day, using Home Diary
Quality of Life and Physician's and Patients Global Evaluations
Time frame: Every visit until year 5
Neuropsychological Evaluations
Time frame: Will occur pre-operatively and at 3, 12 and 24 months post-operatively
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