An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00501969
First received: July 16, 2007
Last updated: March 28, 2012
Last verified: March 2012
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Purpose
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Stage Parkinson's Disease |
Drug: Rotigotine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa |
Resource links provided by NLM:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Rotigotine
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: five years ] [ Designated as safety issue: No ]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: five years ] [ Designated as safety issue: No ]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 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4) ] [ Designated as safety issue: No ]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: | 395 |
| Study Start Date: | August 2004 |
| 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 trans-dermal patches once daily: 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours) Other Name: Neupro®
|
Detailed Description:
This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa
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 four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial
Exclusion Criteria:
- Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501969
Show 53 Study Locations
Show 53 Study LocationsSponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00501969 History of Changes |
| Other Study ID Numbers: | SP516 |
| Study First Received: | July 16, 2007 |
| Results First Received: | December 8, 2009 |
| Last Updated: | March 28, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Austria: Agency for Health and Food Safety Australia: Department of Health and Ageing Therapeutic Goods Administration Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Finland: Finnish Medicines Agency Hungary: National Institute of Pharmacy Israel: Ministry of Health Italy: Ministry of Health New Zealand: Health Research Council Norway: Norwegian Medicines Agency Poland: Ministry of Health South Africa: Department of Health Spain: Ministry of Health Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by UCB, Inc.:
|
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 Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013