Open Label Extension Trial for Rotigotine in Early Stage, Idiopathic Parkinsons' Disease (Part II of Double Blind SP513) - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00599196

Purpose

The purpose 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.

Condition	Intervention	Phase
Early Stage, Idiopathic Parkinson's Disease	Drug: Rotigotine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine CDS in Subjects With Early Stage, Idiopathic Parkinson's Disease(Part II of Double Blind SP513).

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: Rotigotine

U.S. FDA Resources

Further study details as provided by UCB:

Primary Outcome Measures:

Long term safety and tolerability will be determined by Adverse Events, as well as by changes from baseline in vital signs, ECG, clinical laboratory and neurological examination and the Epworth Sleepiness Scale score [ Time Frame: Baseline of double-blind phase to end of treatment ]

Secondary Outcome Measures:

Changes in UPDRS scores, Clinical Global Impression, Hoehn and Yahr stages, Changes in quality of life [ Time Frame: Baseline of double-blind phase to end of treatment ]

Enrollment:	381
Study Start Date:	November 2002
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active treatment with rotigotine, dose adjustment as required.	Drug: Rotigotine Transdermal patches (Sizes 10, 20, 30 and/or 40cm2) 2mg/24h, 4mg/24h, 6mg/24h, 8mg/24h, 12mg/24h, 16mg/24h once daily, 24 hours

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has completed 6 months of maintenance treatment in the double-blind part of SP513

Exclusion Criteria:

Subject has an ongoing serious adverse event in double-blind part of SP513, that is assessed as related to study medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599196

Show 65 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP716
Study First Received:	December 24, 2007
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00599196 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety; Australia: Department of Health and Ageing Therapeutic Goods Administration; Croatia: Ministry of Science, Education and Sports; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Hungary: National Institute of Pharmacy; Israel: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); New Zealand: Health Research Council; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; South Africa: Department of Health; Sweden: Medical Products Agency; Switzerland: Swissmedic; Italy: Ministry of Health; Spain: Comité Ético de Investigación Clínica; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB:

Rotigotine
NEUPRO

Study placed in the following topic categories:

Neurotransmitter Agents
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dopamine Agonists

Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders
N 0437

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 September 03, 2009