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Phase 3 Trial With Safinamide Initiated, Potential Treatment for Parkinson's Disease
This double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi-national, 18-month Phase III trial, is designed to compare two non-overlapping dose ranges of safinamide (50-100 and 150-200 mg/day, orally administered) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in early-stage Parkinson's disease outpatients. Patients enrolled and completing the initial 24 weeks of double-blind treatment will be eligible to enter in a 12-month, double-blind continuation study. The primary efficacy measures will be the change from baseline to endpoint in mean value of UPDRS - Section III (motor score) and the CGI (change from baseline to endpoint, the proportion of patients showing improvement - scores of 1, 2 or 3). UPDRS (Unified Parkinson's Disease Rating Scale) and CGI (Clinical Global Improvement) are specialized scoring systems useful to assess the clinical conditions of Parkinsonian patients.
The continuation study will measure the time from baseline to intervention defined as an increase in dose of the dopamine-agonist; addition of another dopamine-agonist or levodopa, or other anti-Parkinson therapy; or discontinuation due to lack of efficacy.
"The initiation of our first phase III trial brings safinamide a step closer to patients in need of new options to manage their Parkinson's disease," commented Prof. Ruggero Fariello, MD, CSO of Newron Pharmaceuticals. "This study forms the basis of our regulatory submissions to health authorities worldwide. We are encouraged by the data seen to date with safinamide and hope that this will be reflected in the outcome of our larger clinical studies."
In phase II trials in patients with Parkinson's disease, safinamide, co-administered with a dopamine agonist, produced a significant reduction in UPDRS motor scores. Safety of safinamide has also been found to be very favourable to date. These data were recently published in the August 24th issue of Neurology titled "Improvement of Motor Function in Early Parkinson Disease by Safinamide."
About Parkinson's Disease
Parkinson's disease is one of the major neurological disorders, affecting approximately 4 million people worldwide, according to the World Health Organisation. It is characterised as a chronic, progressive degeneration of nerve cells that use the neurotransmitter dopamine in a special area of the brain, called the Substantia Nigra (black substance) that controls muscle tone, initiation and smoothness of movements. Symptoms include limb tremors, muscle rigidity, slowness of motion and postural instability. Current treatments aim at replenishing the lost stores of dopamine or stimulating those dopamine receptors that carry forward dopamine motor messages.
Safinamide is an investigational new drug currently in Phase III clinical trials for the treatment of Parkinson's disease and in Phase II for epilepsy. Safinamide is a unique molecule with multiple mechanisms of action, including sodium channel blocking activity, calcium channel modulation, glutamate release and a potent, selective and reversible inhibition of monoamine oxidase (MAO)-B, without a MAO-A effect and dopamine re-uptake inhibition. Safinamide has demonstrated efficacy in preliminary clinical trials for Parkinson's disease. The development of safinamide in Parkinson's disease is supported in part by a EUR2.7 million grant from the Italian Ministry of Productive Development's Innovation Technology Fund.
Source: Newron Pharmaceuticals SpA