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A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic P...

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Reference: EUCTR2007-002964-90

A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine

Woman and Man

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Extract

The objectives of this trial are to evaluate the efficacy and safety of a dose range of safinamide 50-100 mg p.o. q.a.m., compared to placebo as add-on therapy in subjects with idiopathic Parkinson’s Disease with motor fluctuations, who are receiving a stable dose of levodopa. Evaluate the change from baseline to W24 in daily “on” time (“on” time without dyskinesia plus “on” time with minor dyskinesia) of a dose range of safinamide 50-100 mg p.o. q.a.m., compared to placebo as add-on therapy in subjects with idiopathic Parkinson’s Disease with motor fluctuations, who are receiving a stable dose of levodopa.

Inclusion criteria

  • Ideopathic Parkinson's Disease

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