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

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-001966-10

A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), 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

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Extrait

The primary objective is to evaluate the change from baseline to W78 in dyskinesia using the Dyskinesia Rating Scale during the “on” phase, comparing safinamide (50-100 mg/day) to placebo.

Critère d'inclusion

  • Idiopathic Parkinson's Disease

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