Z7219LO2 Safinamide long-term treatment in fluctuating Parkinson’s Dis
Research type
Research Study
Full title
A Two Year, Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Safinamide 100 mg, Once Daily, as Add-on Therapy, in Idiopathic Parkinson’s Disease Patients with Motor Fluctuations (EVEREST)
IRAS ID
184201
Contact name
Camille Carroll
Contact email
Sponsor organisation
Zambon SpA
Eudract number
2014-002600-24
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
The purpose of this study is to look at the safety and effectiveness of a new drug called safinamide in patients with Parkinson’s disease when it is used in addition to usual medications for Parkinson’s disease, such as L-DOPA.
The study drug will be compared with a placebo (which looks the same as the study drug but contains no active medication).
A placebo is used so that researchers can see if any effects observed in patients taking the study drug are a result of the study drug itself.
The EVEREST Study is a Phase IIIb study. This means that thousands of other people have already taken the study drug but researchers still want to learn more about it. This study is looking at the long-term effects of the study drug because patients diagnosed with Parkinson’s disease may need to take medications for many years.The primary objective of the study is to evaluate the change from Baseline to Endpoint (Week 96) during the 24-hour diary recording period in the daily “OFF” time of safinamide compared to placebo, as add-on therapy in subjects with Idiopathic Parkinson's Disease and with motor fluctuations on stable doses of L-dopa.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0329
Date of REC Opinion
3 Nov 2015
REC opinion
Further Information Favourable Opinion