Neupart
Research type
Research Study
Full title
A MULTICENTER NONINTERVENTIONAL STUDY TO EVALUATE THE EFFECTIVENESS OF NEUPRO® (ROTIGOTINE TRANSDERMAL PATCH) AND LEVODOPA COMBINATION THERAPY IN PATIENTS WITH PARKINSON’S DISEASE (NEUPART)
IRAS ID
160838
Contact name
Nin Bajaj
Contact email
Sponsor organisation
UCB BIOPHARMA SPRL
Research summary
Levodopa (L-dopa) is considered to be the most effective treatment for Parkinson’s disease, however, regardless of its effectiveness, the long-term use of L-dopa causes, in combination with disease progression, the development of a variety of motor-response complications that can be disabling for the patient; Dopamine agonists (DA) such as rotigotine are perceived as less effective in the treatment of Parkinson’s disease and cause additional adverse drug reactions (ADRs) when compared to L dopa. However, DAs have the advantage of providing additional motor and non-motor control, and keeping the L-dopa dose low, thereby decreasing the risk for motor-response complications. Consequently, many patients with Parkinson’s disease are treated with a combination of L-dopa and a DA.
Exclusion of patients from Parkinson’s disease research on the basis of an upper age limit is frequent and can be problematic in smaller studies. Elderly patients often have a greater prevalence of co-morbidities and age-related medical conditions leading to inability to meet clinical study entry requirements. As such, they are frequently under-represented in clinical studies. PD0013 is a multi-center non-interventional study conducted under a routine clinical practice setting. The primary objective of this study is to compare the effectiveness in 2 groups of patients with Parkinson’s disease, aged <70 years and =70 years, who are receiving L-dopa as monotherapy or in combination with a DA (other than rotigotine) after switching to L-dopa and rotigotine transdermal patch under the real life condition. The secondary objective is to assess the tolerability of rotigotine.
The study aims to evaluate the clinical effects of rotigotine and L-dopa in combination therapy for younger and older patients with Parkinson’s disease under a routine clinical practice setting. No randomisation or use of placebos. The use of rotigotine, changes in treatment and overall management will be based on the physician normal practice.
REC name
North of Scotland Research Ethics Committee 2
REC reference
14/NS/1038
Date of REC Opinion
16 Sep 2014
REC opinion
Further Information Favourable Opinion