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

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00244387

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Rotigotine

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Publications:

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
Study First Received:	October 24, 2005
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00244387 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

advanced stage idiopathic Parkinson's disease

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Dopamine Agonists
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders
N 0437

ClinicalTrials.gov processed this record on November 20, 2009