Long-Term Trial to Assess the Effectiveness and Safety of Rotigotine Patch in Early Stage Parkinson's Disease. - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00594165

Purpose

The purpose of this study is to show that rotigotine patch is effective and safe for the long-term treatment of subjects with early stage Parkinson's disease.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Rotigotine	Phase III

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, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Extension to Assess the Safety of Long-Term Treatment of Rotigotine CDS

Further study details as provided by UCB:

Primary Outcome Measures:

Safety: Adverse events, change in hematology and serum biochemistry parameters, change in physical and neurological examination and vital signs, change in 12-lead ECGs, change in Epworth Sleepiness Scale score. [ Time Frame: 7 years ]

Enrollment:	217
Study Start Date:	June 2002
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The subjects dose of rotigotine may be increased, or decreased, as needed to maintain a subject's effective dose during the study.	Drug: Rotigotine 10cm2 (2mg); 20cm2 (4mg); 30cm2 (6mg) and/or 40cm2 (8mg) transdermal patch Optimal dosing: During the first year: The maximum rotigotine dose allowed is 13.5 mg (30cm2) per day. After the first year: Subjects may benefit from a dose increase of rotigotine up to 36.0 mg (80 cm2) per day.

Detailed Description:

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic Parkinson's disease.

Eligibility

Ages Eligible for Study:	31 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have completed six months of maintenance treatment in the double-blind part of SP512 are allowed participation in the open-label part of the study.

Exclusion Criteria:

Subjects who have an ongoing serious adverse event that is assessed as related to study medication are excluded from participation in the open-label extension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594165

Show 42 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP702
Study First Received:	December 24, 2007
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00594165
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by UCB:

Rotigotine
Open label extension study
Neupro

Study placed in the following topic categories:

Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
N 0437

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases

Dopamine Agents
Dopamine Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009