Trial data presented at the Movement Disorder Society’s 13th International Congress of Parkinson’s Disease and Movement Disorders in Paris, France, has further supported the therapeutic benefits of Mirapexin with Sifrol.
The trial, performed on patients with advanced Parkinson’s disease (PD), showed results comparable to pramipexole’s long-established immediate release formulation.
The study supports previous trial data that demonstrated the efficacy, safety and tolerability of the once-daily formulation in the treatment of early PD at 18 weeks, which also showed non-inferiority between pramipexole extended release and pramipexole immediate release at 33 weeks.
National Hospital and Royal Free Hospital Professor of Neurology and lead investigator of the study Anthony Schapira said the most recent study data show that the pramipexole once-daily, extended release formulation is effective not only early on but also in the more advanced stages of Parkinson’s disease.
“The improvement seen in ‘off-time’ as well as the convenience of a once-daily formulation will be of benefit to both patients and physicians,” Schapira said.
The randomised, placebo-controlled trial assessed the efficacy and safety of a once-daily, extended release formulation of pramipexole, when administered as adjunctive therapy in advanced PD as compared to its immediate formulation when administered under the same therapeutic conditions.
Both the primary and the key secondary endpoints were met in the study as measured by the change from baseline in UPDRS II+III and percentage of off-time during waking hours.