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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00519532




Registration number
NCT00519532
Ethics application status
Date submitted
21/08/2007
Date registered
22/08/2007
Date last updated
27/10/2014

Titles & IDs
Public title
Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Scientific 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
Secondary ID [1] 0 0
EudraCT number: 2006-006907-35
Secondary ID [2] 0 0
SP0915
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rotigotine

Experimental: Rotigotine - Rotigotine Transdermal Patch


Treatment: Drugs: 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (baseline SP915) and week 13 (End of maintenance)
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)

Eligibility
Key inclusion criteria
- Completion of trial SP889
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ongoing serious adverse event assessed as related to trial medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Concord
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Finland
State/province [3] 0 0
Oulu
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Dresden
Country [6] 0 0
Germany
State/province [6] 0 0
Kassel
Country [7] 0 0
Germany
State/province [7] 0 0
Marburg
Country [8] 0 0
Germany
State/province [8] 0 0
Naumburg
Country [9] 0 0
Germany
State/province [9] 0 0
Ulm
Country [10] 0 0
Hungary
State/province [10] 0 0
Budapest
Country [11] 0 0
Hungary
State/province [11] 0 0
Nyiregyhaza
Country [12] 0 0
Italy
State/province [12] 0 0
Chieti
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
New Zealand
State/province [14] 0 0
Christchurch
Country [15] 0 0
Poland
State/province [15] 0 0
Olyszytn
Country [16] 0 0
South Africa
State/province [16] 0 0
Cape Town
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Lancashire
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00519532
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00519532