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Sponsored by: |
UCB |
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00244387 |
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.
Condition | Intervention | Phase |
Parkinson Disease, Idiopathic |
Drug: SPM 962 |
Phase III |
Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
MedlinePlus related topics: | Parkinson's Disease |
Drug Information available for: | Pramipexol Pramipexole dihydrochloride Levodopa Rotigotine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centre, Multi-National, Phase 3, Randomized, Double-Blind, Double-Dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SP515 |
First Received: | October 24, 2005 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00244387 |
Health Authority: | United States: Food and Drug Administration |
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