Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease, not well controlled on existing levodopa will take part in a research study at approximately 82 sites in Europe, Israel, South Africa, Australia and new Zealand.
The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months
Each patient who qualifies and chooses to participate in the study will receive either rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7 weeks, and then maintain their optimal dose for 4 months.
The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, completion of various questionnaires, and completion of a diary to record the severity of their Parkinson's symptoms.
Patients who complete the study may enroll in an extension trial and receive active study drug.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Advanced stage idiopathic Parkinson's disease
Exclusion criteria
- Well controlled on levodopa
Trial design
Primary purpose
Allocation
Interventional model
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Trial contacts and locations
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Data sourced from clinicaltrials.gov
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