MONHEIM, Germany, Jan. 3 /PRNewswire/ -- SCHWARZ PHARMA announced today the electronic publication of a pivotal phase III clinical trial in the journal, Neurology. This trial showed positive results of its once daily dopamine agonist, rotigotine, for the treatment of early-stage Parkinson's disease (PD). Rotigotine is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery (through the skin) system. The study, titled "Randomized, Blind, Controlled Trial of Transdermal Rotigotine in Early Parkinson Disease," can be found on Neurology's web site at http://www.neurology.org .
The multi-center, randomized, double-blind study was designed to evaluate the safety and effectiveness of the once-daily dopamine agonist rotigotine, supplied via a once daily transdermal patch that delivers the drug continuously, versus placebo in patients with early-stage PD. The author and lead investigator of the study, Ray L. Watts, MD, Director of Clinical Research and Chairman of Neurology, University of Alabama at Birmingham, concluded that rotigotine, when titrated to a dose of 6mg/24hr, was effective for the treatment of early-stage PD. In addition, rotigotine appeared to be well-tolerated by patients.
"Parkinson's disease is a progressive disorder and this important study showed that rotigotine may be safe and effective, and potentially be of significant value in the treatment of early-stage PD," said Dr. Watts. "Rotigotine is a dopamine agonist that offers continuous drug delivery with a once-daily patch, which will hopefully mitigate the practical intra-day variability that accompanies the multiple dose regimens of other dopaminergic drugs."
Study Design and Results
This phase III clinical trial evaluated 302 patients with early-stage, idiopathic PD at 50 clinical study sites in the United States and Canada. Two hundred seventy-seven patients were randomized to receive placebo (n=96) or rotigotine (n=181). The rotigotine group started treatment with the 2mg/24hr (10 cm squared) patch and titrated weekly up to a maximum dose of 6mg/24hr (30 cm squared). The 27-week study period included a three-week titration phase, followed by a 24-week maintenance phase. There was also a four-week pre-treatment phase and a four-week safety follow-up phase. The primary efficacy measure was the change from baseline in parts II and III of the Unified Parkinson Disease Rating Scale (UPDRS) score, which assesses a patient's ability to perform everyday activities and also evaluates motor symptoms of PD.
Compared with placebo, rotigotine significantly improved patients' symptoms in early-stage PD through six months of therapy as measured by parts II and III of the UPDRS (a decrease in UPDRS scores signifies symptom improvement). Patients in the placebo group had a mean increase in UPDRS subtotals of 1.31 +/- 0.956, while the rotigotine group had a mean decrease in score of 3.98 +/- 0.707 (P < 0.0001). The most commonly reported adverse events (>10 percent) that occurred in patients receiving rotigotine were application site reactions (which were generally mild to moderate in intensity), nausea, somnolence, dizziness, and headache.
Rotigotine is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a patch, designed for once-a-day application. Rotigotine is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning. Rotigotine is currently under review with the U.S. Food and Drug Administration (FDA) for its efficacy and safety as treatment for early-stage PD. At this time, it is marketed in Europe as monotherapy for early-stage PD and has received a favorable review for advanced-stage PD.
About Parkinson's Disease
Parkinson's disease is a progressive disorder of the central nervous system. The patients -- roughly four million worldwide, including approximately 1 million people in the U.S. -- suffer primarily from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists are drugs that attempt to compensate for this lack of dopamine.
SCHWARZ PHARMA (headquartered in Monheim, Germany) is a stock listed company with approximately 4,400 employees worldwide. The company develops novel medicines in the therapeutic areas of the central nervous system. Furthermore it markets innovative drugs focused to treat cardiovascular and gastro-intestinal diseases. In 2005 the SCHWARZ PHARMA group achieved global sales of nearly euro 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia.
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