An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease - Full Text View

Purpose

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

Condition	Intervention	Phase
Idiopathic Parkinson's Disease	Drug: Rotigotine	Phase 3


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Rotigotine

U.S. FDA Resources

Further study details as provided by UCB Pharma:

Primary Outcome Measures:

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: four years ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Secondary Outcome Measures:

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: four years ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Mean Epworth Sleepiness Scale Score During the Open-label Extension. [ Time Frame: Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit) ]
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.


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
Experimental: Rotigotine Rotigotine	Drug: Rotigotine Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: The maximum rotigotine dose allowed is 16 mg/24 hours. Other Name: Neupro

Detailed Description:

This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Eligibility


Ages Eligible for Study:	31 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials

Exclusion Criteria:

Subjects who had an ongoing serious adverse event from the previous OLE trial that was assessed as related to study medication

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 26 Study Locations

Sponsors and Collaborators

UCB Pharma

Investigators


Study Director:	UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site


Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT00505687 History of Changes
Other Study ID Numbers:	SP0833 2004-002641-12 ( EudraCT Number )
Study First Received:	July 20, 2007
Results First Received:	December 8, 2009
Last Updated:	September 24, 2014

Keywords provided by UCB Pharma:


Rotigotine Neupro®

Additional relevant MeSH terms:


Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders	Neurodegenerative Diseases N 0437 Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 17, 2017