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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00474058




Registration number
NCT00474058
Ethics application status
Date submitted
14/05/2007
Date registered
16/05/2007
Date last updated
22/06/2015

Titles & IDs
Public title
Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
Scientific title
Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease
Secondary ID [1] 0 0
EudraCT No.: 2006-006752-35
Secondary ID [2] 0 0
SP0889
Universal Trial Number (UTN)
Trial acronym
RECOVER
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
Other interventions - Placebo

Experimental: Rotigotine - Rotigotine transdermal patch

Placebo Comparator: Placebo - Placebo 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

Other interventions: Placebo
Placebo transdermal patches

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Early Morning UPDRS Part III Score - The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
Timepoint [1] 0 0
From baseline to end of maintenance (after 4 weeks maintenance)
Primary outcome [2] 0 0
Change in Parkinson's Disease Sleep Scale (PDSS) - The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions.
Timepoint [2] 0 0
From baseline to end of maintenance (after 4 weeks maintenance)
Secondary outcome [1] 0 0
Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) - 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.
Timepoint [1] 0 0
From baseline to end of maintenance (after 4 weeks maintenance)
Secondary outcome [2] 0 0
Change in Number of Nocturias - Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders.
Timepoint [2] 0 0
From baseline to end of maintenance (after 4 weeks maintenance)

Eligibility
Key inclusion criteria
- Early and advanced Idiopathic Parkinson Disease with early morning motor impairment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Atypical Parkinsonian syndromes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
NSW,SA
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Austria
State/province [6] 0 0
Innsbruck
Country [7] 0 0
Finland
State/province [7] 0 0
Hyvinkää
Country [8] 0 0
Finland
State/province [8] 0 0
Oulu
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Dresden
Country [11] 0 0
Germany
State/province [11] 0 0
Kassel
Country [12] 0 0
Germany
State/province [12] 0 0
Leipzig
Country [13] 0 0
Germany
State/province [13] 0 0
Marburg
Country [14] 0 0
Germany
State/province [14] 0 0
Naumburg
Country [15] 0 0
Germany
State/province [15] 0 0
Ulm
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Hungary
State/province [18] 0 0
Nyiregyhaza
Country [19] 0 0
Hungary
State/province [19] 0 0
Zalaegerszeg
Country [20] 0 0
Italy
State/province [20] 0 0
Chieti
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Italy
State/province [22] 0 0
Torino
Country [23] 0 0
New Zealand
State/province [23] 0 0
Christ Church
Country [24] 0 0
New Zealand
State/province [24] 0 0
Wellington
Country [25] 0 0
Poland
State/province [25] 0 0
Gdansk
Country [26] 0 0
Poland
State/province [26] 0 0
Krakow
Country [27] 0 0
Poland
State/province [27] 0 0
Lublin
Country [28] 0 0
Poland
State/province [28] 0 0
Olsztyn
Country [29] 0 0
Poland
State/province [29] 0 0
Szczecin
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
South Africa
State/province [31] 0 0
Cape Town
Country [32] 0 0
South Africa
State/province [32] 0 0
Capetown
Country [33] 0 0
South Africa
State/province [33] 0 0
Johannesburg
Country [34] 0 0
South Africa
State/province [34] 0 0
Pretoria/Gauteng
Country [35] 0 0
South Africa
State/province [35] 0 0
Tygerberg
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Bristol
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Lancashire
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Liverpool
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London

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 trial is to assess the effects of transdermal rotigotine on the control
of early morning motor function and sleep disorders compared to placebo in subjects with
idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and
non-motor symptoms of Parkinson´s disease will be evaluated.
Trial website
https://clinicaltrials.gov/show/NCT00474058
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
Other publications