Clinical trial NCT00474058: Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: rotigotine
Neupro®
Parkinson's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The objective of this trial is to assess the effects of 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.

After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.

Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

Eligibility criteria: Inclusion Criteria:

* Early and advanced Idiopathic Parkinson Disease with early morning motor impairment

Exclusion Criteria:

* Atypical Parkinsonian syndromes

Primary outcomes:
measure: Change in Early Morning UPDRS Part III Score
timeFrame: From baseline to end of maintenance (after 4 weeks maintenance)
measure: Change in Parkinson's Disease Sleep Scale (PDSS)
timeFrame: From baseline to end of maintenance (after 4 weeks maintenance)
Secondary outcomes:
measure: Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)
timeFrame: From baseline to end of maintenance (after 4 weeks maintenance)
measure: Change in Number of Nocturias
timeFrame: From baseline to end of maintenance (after 4 weeks maintenance)
Other outcomes:
Locations:
city: Reseda
country: United States
state: California
city: Ventura
country: United States
state: California
city: St. Petersburg
country: United States
state: Florida
city: Salisbury
country: United States
state: North Carolina
city: Winston_Salem
country: United States
state: North Carolina
city: Warwick
country: United States
state: Rhode Island
city: Houston
country: United States
state: Texas
city: Concord
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Fitzroy
country: Australia
city: Innsbruck
country: Austria
city: Hyvinkää
country: Finland
city: Oulu
country: Finland
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Kassel
country: Germany
city: Leipzig
country: Germany
city: Marburg
country: Germany
city: Naumburg
country: Germany
city: Ulm
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Chieti
country: Italy
city: Milano
country: Italy
city: Torino
country: Italy
city: Christ Church
country: New Zealand
city: Wellington
country: New Zealand
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Cape Town
country: South Africa
city: Capetown
country: South Africa
city: Johannesburg
country: South Africa
city: Pretoria/Gauteng
country: South Africa
city: Tygerberg
country: South Africa
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Bristol
country: United Kingdom
city: Lancashire
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Ghys L, Surmann E, Whitesides J, Boroojerdi B. Effect of rotigotine on sleep and quality of life in Parkinson's disease patients: post hoc analysis of RECOVER patients who were symptomatic at baseline. Expert Opin Pharmacother. 2011 Sep;12(13):1985-98. doi: 10.1517/14656566.2011.604031. Epub 2011 Jul 27.
citation: Kassubek J, Chaudhuri KR, Zesiewicz T, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study. BMC Neurol. 2014 Mar 6;14:42. doi: 10.1186/1471-2377-14-42.
citation: Swick TJ, Friedman JH, Chaudhuri KR, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Associations between severity of motor function and nonmotor symptoms in Parkinson's disease: a post hoc analysis of the RECOVER Study. Eur Neurol. 2014;71(3-4):140-7. doi: 10.1159/000355019. Epub 2014 Jan 21.
citation: Trenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Honczarenko K, Dioszeghy P, Hill D, Anderson T, Myllyla V, Kassubek J, Steiger M, Zucconi M, Tolosa E, Poewe W, Surmann E, Whitesides J, Boroojerdi B, Chaudhuri KR; Recover Study Group. Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord. 2011 Jan;26(1):90-9. doi: 10.1002/mds.23441. Epub 2010 Nov 18.