Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa - Full Text View

Purpose

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

U.S. FDA Resources

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

Further study details as provided by UCB:

Enrollment:	506
Study Start Date:	March 2004
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Advanced stage idiopathic Parkinson's disease

Exclusion Criteria:

Well controlled on levodopa

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244387

Locations


Germany
	Schwarz
	Monheim, Germany

Sponsors and Collaborators

UCB

Investigators


Study Director:	Diane Maguire	Schwarz

More Information

Publications of Results:

Poewe WH, Rascol O, Quinn N, Tolosa E, Oertel WH, Martignoni E, Rupp M, Boroojerdi B; SP 515 Investigators. Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's disease: a double-blind, double-dummy, randomised controlled trial. Lancet Neurol. 2007 Jun;6(6):513-20.

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