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

Idiopathic Parkinson's Disease Clinical Trial

— NEUPART  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227355
• Other study ID #: PD0013
• Status: Completed
• Phase: N/A
• First received: August 26, 2014
• Last updated: July 1, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Conseil National de l'Ordre des MédecinsGermany: Ministry of HealthGermany: Ethics CommissionItaly: The Italian Medicines AgencyItaly: Ethics CommitteeSpain: Ethics CommitteeSpain: Spanish Agency of MedicinesUnited Kingdom: Research Councils UKUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.	PRA Health Sciences

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change from Baseline to end of the Observational Period in L-dopa dose		Baseline to end of Observational Period (6 months)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No