Parkinson's disease progression slows down in phase III clinical study of ADAGIO that used Azilect 1mg tablets.
Lundbeck's partner Teva Pharmaceutical Industries Ltd. has today announced the successful completion of ADAGIO, the phase III trial designed to demonstrate that Azilect 1 mg tablets can slow down the progression of Parkinson's disease. In the trial, the currently marketed Azilect 1 mg tablets met all three primary end points, as well as the secondary and additional end points, all with statistical significance. The study also confirmed the safety and tolerability of Azilect.
Disease
Lundbeck markets Azilect in Europe. In the three major European markets, the United Kingdom, Germany and France, Teva and Lundbeck co-promote Azilect .
ADAGIO is a randomized, multi-center, double-blind, placebo-controlled, parallel-group study prospectively examining rasagiline's potential disease-modifying effects in 1,176 patients with early, untreated Parkinson's disease. Patients from 129 centers in 14 countries were randomized to early-start treatment (72 weeks rasagiline 1 or 2 mg once daily) or delayed-start treatment (36 weeks placebo followed by 36 weeks rasagiline 1 or 2 mg once daily [active treatment phase]). The primary analyses of the trial were based on change in total UPDRS (Unified Parkinson's Disease Rating Scale).
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders.
According to the report of Parkinson's Disease Foundation "Parkinson's disease is a movement disorder that is chronic and progressive, meaning that symptoms continue and worsen over time. As many as one million Americans suffer from Parkinson's disease. While approximately 15 percent of people with Parkinson's are diagnosed before the age of 50, incidence increases with age. The cause is unknown, and although there is presently no cure, there are many treatment options such as medication and surgery to manage the symptoms. (For more statistics on Parkinson's disease, read our fact sheet, General Facts on Parkinson's Disease)."