Effects of Rotigotine Transdermal System in Subjects With Advanced-Stage Idiopathic Parkinson's Disease - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00292227

Purpose

Rotigotine (SPM 962) transdermal patch is in development for early- and advanced-stage Parkinson's disease (patch sizes/doses of up to 40 cm2/18.0 mg/day and 80 cm2/36.0 mg/day, respectively) and for restless legs syndrome (up to 15 cm2/6.75 mg/day). During development, electrocardiographic data were collected in subjects treated with rotigotine in doses up to 36.0 mg/day. These evaluations provided no indication for drug-induced prolongation of QT/QTc interval by rotigotine in the target population. Schwarz will conduct a thorough QT/QTc trial according to current regulatory guidelines. This trial investigates potential electrocardiographic effects of rotigotine in doses up to 120 cm2/54.0 mg/day (reflecting supratherapeutic doses for the advanced-stage Parkinson´s disease indication) in a double-blind, randomized, placebo- and positive-controlled thorough QT/QTc trial in subjects with advanced-stage idiopathic Parkinson's disease.

Condition	Intervention	Phase
Parkinson's Disease	Drug: SPM-962	Phase I Phase II

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Rotigotine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Randomized, Placebo- and Positive-Controlled, Parallel-Group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-Stage Idiopathic Parkinson's Disease: A "Thorough" QT/QTc Trial

Further study details as provided by UCB:

Study Start Date:	January 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Advanced-stage idiopathic Parkinson's disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292227

Locations

South Africa
Qdot
George, South Africa

Sponsors and Collaborators

UCB

Investigators

Study Director:

Joerg Hoeckendorff

Schwarz BioSciences

More Information

No publications provided

Study ID Numbers:	SP864
Study First Received:	February 14, 2006
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00292227 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

advanced-stage idiopathic Parkinson's disease

Study placed in the following topic categories:

Ganglion Cysts
Arnold-Chiari Malformation
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009