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Clinical trial

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

NCT00627640 is registered in ClinicalTrials.gov with Newron Pharmaceuticals SPA as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Newron Pharmaceuticals SPA
Phase
Phase 3
Overall status
Completed
Start date
February 28, 2009
Completion date
March 31, 2012
Enrollment
549 (actual)
Sites
121

Conditions

As the registry lists them; a condition with its own page is linked.

idiopathic parkinson's disease