Open Label Follow up Trial of Rotigotine in Parkinson's Disease - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00505687

Purpose

This is a Phase 3b, multinational, multicenter, open-label trial to assess the long-term safety and tolerability of rotigotine transdermal patch in subjects with idiopathic Parkinson's Disease.

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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease

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:

The primary focus of the trial is to assess tolerability and safety over the course of the trial. This includes: Frequency and severity of AEs, changes in vital signs, body weight, ECGs and clinical laboratory values. [ Time Frame: over the course of the trial ]

Secondary Outcome Measures:

Quality of sleep; quality of life; staging of severity of PD, motor performance [ Time Frame: Efficacy Parameters will be evaluated descriptively for changes in baseline ]

Enrollment:	186
Study Start Date:	February 2005
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rotigotine transdermal patch 2mg/24h - 16mg/24h, once daily	Drug: Rotigotine 10cm2 (2mg), 20cm2 (4mg), 30cm2 (6mg) and/or 40cm2 (8mg) Transdermal patch: 2mg/24h - 16mg/24h, once daily for duration of the trial

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has completed parent trial SP824, SP825, or SP826

Exclusion Criteria:

Subject has an ongoing adverse event that is assessed as related to study medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505687

Show 26 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:	SP833, EudraCT Number 2004-002641-12
Study First Received:	July 20, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00505687 History of Changes
Health Authority:	United States: Food and Drug Administration; Austria: Agency for Health and Food Safety; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Israel: Ethics Commission; South Africa: Department of Health; Spain: Spanish Agency of Medicines; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB:

Idiopathic Parkinson's disease

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 11, 2009