Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00519532
• Other study ID #: SP0915
• Secondary ID: EudraCT number:
• Status: Terminated
• Phase: Phase 3
• First received: August 21, 2007
• Last updated: October 17, 2014
• Start date: July 2007
• Est. completion date: May 2009

Study information

• Verified date: September 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthSpain: Spanish Agency of MedicinesHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyAustria: Agency for Health and Food SafetyFinland: Finnish Medicines AgencyNew Zealand: MedsafeSouth Africa: Medicines Control CouncilAustralia: Department of Health and Ageing Therapeutic Goods AdministrationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completion of trial SP889

Exclusion Criteria:

• Ongoing serious adverse event assessed as related to trial medication

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Finland,  Germany,  Hungary,  Italy,  New Zealand,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)	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.	Baseline (baseline SP915) and week 13 (End of maintenance)	No
Primary	Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)	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.	Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)	No
Secondary	Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)	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.	Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)	No
Secondary	Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)	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.	Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)	No

External Links

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