Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)

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)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Parkinson's Disease

• Study Type: Observational
• Enrollment (Actual): 195

Contacts and Locations

Study Locations

• France
  • Lille, France
    • 42
  • Mougins, France
    • 41
  • Nimes, France
    • 40
• Germany
  • Alzenau, Germany
    • 6
  • Aschaffenburg, Germany
    • 51
  • Beelitz-Heilstätten, Germany
    • 13
  • Berlin, Germany
    • 12
  • Böblingen, Germany
    • 5
  • Düsseldorf, Germany
    • 53
  • Erbach, Germany
    • 7
  • Haag, Germany
    • 4
  • Leer, Germany
    • 11
  • Münster, Germany
    • 2
  • Schriesheim, Germany
    • 54
  • Senftenberg, Germany
    • 8
  • Tübingen, Germany
    • 14
  • Ulm, Germany
    • 10
  • Westerstede, Germany
    • 3
• Italy
  • Ancona, Italy
    • 45
  • Brescia, Italy
    • 47
  • Cagliari, Italy
    • 60
  • Cosenza, Italy
    • 29
  • Firenze, Italy
    • 30
  • Milano, Italy
    • 46
  • Napoli, Italy
    • 27
  • Roma, Italy
    • 28
  • Roma, Italy
    • 62
• Spain
  • Barakaldo, Spain
    • 20
  • Donostia San Sebastian, Spain
    • 15
  • Madrid, Spain
    • 24
  • Palma de Mallorca, Spain
    • 22
• United Kingdom
  • Bury, United Kingdom
    • 37
  • Cambridge, United Kingdom
    • 49
  • Lincoln, United Kingdom
    • 52
  • Liverpool, United Kingdom
    • 48
  • London, United Kingdom
    • 33
  • London, United Kingdom
    • 36
  • Manchester, United Kingdom
    • 34
  • Middlesborough, United Kingdom
    • 31
  • North Shields, United Kingdom
    • 38
  • Norwich, United Kingdom
    • 35
  • Plymouth, United Kingdom
    • 63

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PD Patients < 70 years of age; Patients with Parkinson's Disease (PD) <70 years of age.
PD Patients ≥ 70 years of age; Patients with Parkinson's Disease (PD) ≥ 70 years of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score	The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions=52 points maximum; the higher the sum score, the greater degree of disability).	Baseline to end of Observational Period (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to end of the Observational Period in L-dopa dose		Baseline to end of Observational Period (6 months)
Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score	The PDSS-2 is a 15 item scale that is used to assess sleep and nocturnal disability in Parkinson's Disease. It is designed for interviewer-administered completion or self-completion by patients. Patients are asked to rate how often during the past week he/she slept well or experienced various symptoms of sleep disability. Each of the 15 items are to be scored between 0 (never) to 4 (very often) with the total score ranging from 0 to 60; the higher the sum score, the greater the degree of impairment.	Baseline to end of Observational Period (6 months)
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	The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions = 52 points maximum); the higher the sum score, the greater degree of disability.	End of the Observation Period (Month 6)
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)	CGI Item 2 (Global Rating of Change of Condition) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. Scores range from 0 to 7 as follows: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.	End of the Observation Period (Month 6)

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.
• Collaborators: PRA Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: July 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Rotigotine; Levodopa; Neupro®; Combination therapy; Transdermal patch; NEUPART; Noninterventional
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD0013