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15 patients received ProSavin and were followed up (three at low dose, six mid dose, six high dose). During the first 12 months of follow-up, 54 drug-related adverse events were reported (51 mild, three moderate). Most common were increased on-medication dyskinesias (20 events, 11 patients) and on-off phenomena (12 events, nine patients ). N6 serious adverse events related to the study drug or surgical procedure were reported. A significant improvement in mean UPDRS part III motor scores off medication was recorded in all patients at 6 months (mean score 38 ?SD 9? vs 26 ?8?, n=15, p=0.0001) compared with baseline. ProSavin was safe and well tolerated in patients with advanced Parkinson?s disease. Improvement in motor behavior was observed in all patients. |
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