HONOLULU, April 12, 2011 /PRNewswire-USNewswire/ — 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’s 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 two-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.
Symptoms of Parkinson’s disease, motor fluctuations and dyskinesia
can greatly affect a person’s daily living and quality of
For the two-year study, 669 patients with mid-to-late stage
Parkinson’s disease who were already taking levodopa and other
dopaminergic treatments were given 50 or 100 milligrams 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 milligram
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
milligram dose had an average score of 3.7.
After two years, researchers discovered in a post-hoc analysis
that safinamide at 100 milligrams a day on top of taking levodopa