NCT03881371

A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Zambon SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the effects of 100 mg safinamide, administered orally once daily (OD), in Chinese Parkinson's disease (PD) patients, experiencing motor fluctuations while on stable doses of Levodopa (L-dopa) (alone or in combination with other anti-Parkinson drugs). Eligible patients are required to meet the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria. The study involves a placebo group. Placebo will be added to the standard stabilized treatment as a control of the safinamide group, hence patients on placebo will have benefit from other ongoing anti-PD medication. A total of 306 patients will be randomised into this study (153 in the safinamide and 153 in the placebo groups).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Safinamide	At baseline (Day 1), eligible patients will be randomised to receive safinamide (initial 50 mg titrated to 100 mg the day after the Visit 3/week 2, ideally at day 15). The investigational medicinal product (IMP) will be taken in the morning at breakfast time, in addition to the morning dose of L-dopa and other (if any) PD medications.
OTHER	Placebo	At baseline (Day 1), eligible patients will be randomised to receive matching placebo, orally OD. Placebo will be added to the standard stabilized treatment as a control of the safinamide group, hence patients on placebo will have benefit from other ongoing anti-PD medication

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-20
• Completion: 2021-08-20
• First posted: 2019-03-19
• Last updated: 2024-03-20
• Results posted: 2024-03-20

Locations

31 sites across 1 country: China