The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
544
Mean change in the dyskinesias rating scale (DRS) during "on" time
mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).
Time frame: Up to 104 weeks (from baseline 016 to EOS study 018)
Endpoints include 'ON time', responder rates and UPDRS IV change
* Chge in ON time (ON+ON minor dysk), * Diary Resp Rate at 12-m, 18 \& 24 m on the ITT\&mITT pop\&pts who completed 2-yr period * UPDRS IV chge in total score,items 32-35 \& 32-34 * Time develop tblsome dysk(\> 30min incr of tblsome dysk) * Time develop any (minor \&/or tblsome) dysk (\> 30 min incr of dysk) * Chge ADLs during ON, vs pbo(UPDRS II) * Maintenance of effect in UPDRS II "resp'(resp \>=20% impr in ADLs). * chge in L-dopa dose * chge in any PD(other than L-dopa)drug dose * Chge in UPDRS III, CGI-C and CGI-S * Chge in diary categories(ON, OFF, ON minor dysk, ON tblsome dysk, ASLEEP)
Time frame: Up to 104 weeks (from baseline 016 to EOS study 018)
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