A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects w...

Update Il y a 4 ans
Reference: EUCTR2008-004146-88

A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist

Woman and Man

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Extract

The primary objective is to evaluate the time to first intervention of two doses of safinamide (50 and 100 mg/day) compared to placebo as add-on therapy to a single dopamine agonist.


Inclusion criteria

  • Idiopathic Parkinson's Disease