Results of the first randomized, placebo-controlled, long-term clinical trial show the investigational drug safinamide may reduce dyskinesia, or involuntary movements, in mid-to-late stage Parkinson disease. The findings will be presented as late-breaking research at the 63rd Annual Meeting of the American Academy of Neurology, April 9-16, 2011, in Honolulu.
"Our findings over a 2-year treatment period suggest that taking safinamide in addition to levodopa and other dopaminergic treatments could help patients who continue to experience tremors and involuntary movement problems," said study author Ravi Anand MD, a consultant with Newron Pharmaceuticals in Bresso, Italy. "These results are an important step forward in understanding how safinamide impacts patients with severe Parkinson's disease...."
For the 2-year study, 669 patients with mid-to-late stage Parkinson disease who were already taking levodopa and other dopaminergic treatments were given 50 or 100 mg of safinamide per day or a placebo pill. Scientists tested participant's movement ability using the United Parkinson's Disease Rating Scale that measures activities such as tremor, speech, behavior, mood, and daily activities including swallowing, dressing and walking. A specific tool measuring severity of dyskinesia (DRS) was used in addition as primary efficacy endpoint.
At the start of the study, patients who took the 50 mg dose of safinamide had an average score of 3.9 compared to a score of 3.4 for those taking a placebo pill. Patients who took the 100 mg dose had an average score of 3.7.
After 2 years, researchers discovered in a post-hoc analysis that safinamide at 100 mg a day on top of taking levodopa reduced dyskinesia, or movement problems, by 24% in the one third of participants who had scored a 4 or higher on the dyskinesia rating scale at the beginning of the study compared to those taking a placebo. There were no significant differences for people who took the 50 mg dose.
There were no significant differences in the primary efficacy measure (movement control, ie, dyskinesia) scores in the overall population. Side effects were comparable among the 3 treatment groups.
The study was supported by Newron/Merck Serono S.A.-Geneva.
Source: News Release
American Academy of Neurology
April 12, 2011