CompletedPhase 3

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

China307 participantsStarted 2019-08-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients aged ≥18 years old.
✓. Chinese ethnicity.
✓. Able to understand and willing to provide written informed consent.
✓. Able to maintain an accurate and complete 24-hour diary with the help of a caregiver.
✓. Diagnosis of idiopathic Parkinson's Disease (IPD) using the United Kingdom Parkinson's Disease Society Brain Bank criteria of more than 3 years duration.
✓. Be levodopa responsive and receiving treatment with stable daily doses of oral L-dopa, with or without benserazide/carbidopa, with or without addition of a catechol-O-methyltransferase (COMT) inhibitor and may be receiving concomitant treatment with stable doses of dopamine agonists, anticholinergics and/or amantadine for at least 4 weeks prior to the screening visit.
✓. A Hoehn and Yahr stage between 1-4 inclusive during the "ON" phase.
✓. Experiencing motor fluctuations with a minimum of 1.5 hours/day of "OFF" time during the day (excluding morning akinesia), based on historical data.

Exclusion criteria

What they're measuring

Change From Baseline to Week 16 in the Mean Total Daily "OFF" Time

Timeframe: At baseline and Week 16

Trial details

NCT IDNCT03881371

SponsorZambon SpA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-20

Results submitted2022-06-09

View on ClinicalTrials.gov More Parkinson Disease trials