Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
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Purpose
The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Rotigotine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease |
- Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP915) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
Baseline is defined as first titration visit (T1) of SP915.
- Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]
The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
- Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]
Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
- Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]
The change in number of nocturias was used to evaluate improvements in sleep disorders.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
| Enrollment: | 84 |
| Study Start Date: | July 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rotigotine
Rotigotine Transdermal Patch
|
Drug: Rotigotine
Rotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h Other Name: Neupro®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Completion of trial SP889
Exclusion Criteria:
- Ongoing serious adverse event assessed as related to trial medication
Contacts and Locations| United States, Florida | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, North Carolina | |
| Salisbury, North Carolina, United States, 28144 | |
| Australia | |
| Concord, Australia | |
| Finland | |
| Oulu, Finland, 90220 | |
| Germany | |
| Berlin, Germany, 10713 | |
| Dresden, Germany, 01307 | |
| Kassel, Germany, 34128 | |
| Marburg, Germany, 35039 | |
| Naumburg, Germany, 06618 | |
| Ulm, Germany, 89081 | |
| Hungary | |
| Budapest, Hungary, 1145 | |
| Nyiregyhaza, Hungary, 4400 | |
| Italy | |
| Chieti, Italy | |
| Milano, Italy, 20127 | |
| New Zealand | |
| Christchurch, New Zealand | |
| Poland | |
| Olyszytn, Poland | |
| South Africa | |
| Cape Town, South Africa | |
| Spain | |
| Barcelona, Spain | |
| Madrid, Spain | |
| United Kingdom | |
| Lancashire, United Kingdom | |
| Liverpool, United Kingdom, L9 7JL | |
| 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: | NCT00519532 History of Changes |
| Other Study ID Numbers: | SP915, EudraCT number: 2006-006907-35 |
| Study First Received: | August 21, 2007 |
| Results First Received: | March 17, 2010 |
| Last Updated: | August 30, 2011 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Spain: Spanish Agency of Medicines Hungary: National Institute of Pharmacy United Kingdom: Medicines and Healthcare Products Regulatory Agency Austria: Agency for Health and Food Safety Finland: Finnish Medicines Agency New Zealand: Medsafe South Africa: Medicines Control Council Australia: Department of Health and Ageing Therapeutic Goods Administration Poland: Ministry of Health |
Keywords provided by UCB, Inc.:
|
Neupro® Rotigotine Parkinson's Disease |
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