Clinical trial NCT02227355: Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease
Official title: A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease
Neupro®
Rotigotine
Transdermal patch
NEUPART
Levodopa
Noninterventional
Combination therapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2014-08-28
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with idiopathic Parkinson's Disease receiving levodopa as monotherapy or in combination with a dopamine agonist other than Rotigotine, but either not sufficiently controlled on or intolerant to current treatment, or other reason; patients are receiving treatment in general practitioner (GP) offices, private clinics or hospitals (including university hospitals) according to routine daily practice.

Brief summary: This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.


Eligibility criteria: Inclusion Criteria:

The following selection criteria must be followed for patients entering the Noninterventional Study (NIS):

* The decision by the treating physician to prescribe Rotigotine transdermal patch is made before participating in the NIS due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
* The patient is either male or female and over 18 years of age
* A Patient Data Consent form is signed and dated by the patient or by the legal representative
* The patient has idiopathic Parkinson's Disease, has not received Rotigotine within 28 days prior to the Baseline Visit and is willing to participate in questionnaire based assessments
* The patient is receiving L-dopa as monotherapy or a combination therapy composed of L-dopa and a dopamine agonist other than Rotigotine
* The patient has been on L-dopa therapy for at least 6 months and is responding to initial L-dopa therapy
* The patient has a Hoehn and Yahr stage score of 1 to 4.

Exclusion Criteria:

* Patients will be excluded from the study if they have participated in a clinical study of a medication or a medical device within 3 months prior to Baseline or if they are participating in a clinical study at the time of inclusion or have already participated in the current study.

Primary outcomes:
measure: Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
timeFrame: Baseline to end of Observational Period (6 months)
Secondary outcomes:
measure: Change from Baseline to end of the Observational Period in L-dopa dose
timeFrame: Baseline to end of Observational Period (6 months)
measure: Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score
timeFrame: Baseline to end of Observational Period (6 months)
measure: Response at the end of the Observation Period defined as 20 % decrease in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
timeFrame: End of the Observation Period (Month 6)
measure: Assessment at the end of the Observation Period in the score of the Clinical Global Impressions (CGI) Item 2 (Global Rating of Change of Condition)
timeFrame: End of the Observation Period (Month 6)
Other outcomes:
Locations:
city: Lille
country: France
facility: 42
city: Mougins
country: France
facility: 41
city: Nimes
country: France
facility: 40
city: Alzenau
country: Germany
facility: 6
city: Aschaffenburg
country: Germany
facility: 51
city: Beelitz-Heilstätten
country: Germany
facility: 13
city: Berlin
country: Germany
facility: 12
city: Böblingen
country: Germany
facility: 5
city: Düsseldorf
country: Germany
facility: 53
city: Erbach
country: Germany
facility: 7
city: Haag
country: Germany
facility: 4
city: Leer
country: Germany
facility: 11
city: Münster
country: Germany
facility: 2
city: Schriesheim
country: Germany
facility: 54
city: Senftenberg
country: Germany
facility: 8
city: Tübingen
country: Germany
facility: 14
city: Ulm
country: Germany
facility: 10
city: Westerstede
country: Germany
facility: 3
city: Ancona
country: Italy
facility: 45
city: Brescia
country: Italy
facility: 47
city: Cagliari
country: Italy
facility: 60
city: Cosenza
country: Italy
facility: 29
city: Firenze
country: Italy
facility: 30
city: Milano
country: Italy
facility: 46
city: Napoli
country: Italy
facility: 27
city: Roma
country: Italy
facility: 28
city: Roma
country: Italy
facility: 62
city: Barakaldo
country: Spain
facility: 20
city: Donostia San Sebastian
country: Spain
facility: 15
city: Madrid
country: Spain
facility: 24
city: Palma de Mallorca
country: Spain
facility: 22
city: Bury
country: United Kingdom
facility: 37
city: Cambridge
country: United Kingdom
facility: 49
city: Lincoln
country: United Kingdom
facility: 52
city: Liverpool
country: United Kingdom
facility: 48
city: London
country: United Kingdom
facility: 33
city: London
country: United Kingdom
facility: 36
city: Manchester
country: United Kingdom
facility: 34
city: Middlesborough
country: United Kingdom
facility: 31
city: North Shields
country: United Kingdom
facility: 38
city: Norwich
country: United Kingdom
facility: 35
city: Plymouth
country: United Kingdom
facility: 63
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: