NCT03841604

Effect of Safinamide on Parkinson's Disease Related Chronic Pain

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Zambon SpA · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a Phase IV, international, multicentre, randomised, double-blind, placebo controlled study in idiopathic Parkinson's disease (IPD) patients, experiencing motor fluctuations and PD-related chronic pain while on stable doses of levodopa (L-Dopa), to Evaluate the Efficacy and Safety of Safinamide 100 mg Once Daily, as Add-On Therapy. The study consisted of: * A screening period of up to 1 to 2 weeks. * A treatment period of 16 weeks. * A telephone follow-up call at 1 week after the end of treatment. Eligible subjects were randomly assigned in a ratio of 2:1 to receive either safinamide (50 mg or 100 mg) or matching placebo. At Day 1, eligible subjects entered the treatment period to receive safinamide 50 mg (from Day 1 to Day 7) and then 100 mg (from Day 8 onwards) orally OD. After completion of all baseline assessments, subjects received the first dose of study drug at the study center and, thereafter, study drug was to be taken at home each morning along with their first morning dose of L-DOPA and other (if any) PD medications. On Day 8, the dose of study drug was increased, at home, to 100 mg OD. Each subject received treatment for 16 weeks, with visits at Week 0/Day 1 (baseline) and at Weeks 4, 8, and 16 (or early termination). From Day 1 onwards, subjects recorded the use of as-needed (PRN) medications along with indicating the worst pain they experienced on a daily basis.

Conditions

• Idiopathic Parkinson Disease

Interventions

Type	Name	Description
DRUG	Safinamide Methanesulfonate	50 mg, 100 mg
OTHER	Safinamide methanesulfonate matching placebo	50 mg, 100 mg

Timeline

• Start date: 2019-04-09
• Primary completion: 2021-04-30
• Completion: 2021-05-03
• First posted: 2019-02-15
• Last updated: 2023-05-22
• Results posted: 2023-05-22

Locations

45 sites across 5 countries: Austria, France, Germany, Italy, Spain