At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain
In Brief
A Phase 4 clinical trial evaluating Safinamide Methanesulfonate and Safinamide methanesulfonate matching placebo for Idiopathic Parkinson Disease. Completed, enrolled 94 participants across 45 sites in 5 countries.
Detailed Summary
Primary objective: • To evaluate the potential efficacy of safinamide 100 mg once daily (OD), compared with placebo, as add-on therapy for PD-related chronic pain Secondary objectives: * Percentage of pain responders * Clinical Global Impression for pain * Patient Global Impression for pain * Reduction in use of pain drugs * Mood * Motor and non-motor symptoms Safety Objectives: • Safety and tolerability
Study Details
Timeline
Interventions
50 mg, 100 mg
50 mg, 100 mg