Status:
COMPLETED
Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease
Lead Sponsor:
UCB Biopharma S.P.R.L.
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
18+ years
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT02227355
Start Date
September 1 2014
End Date
June 1 2016
Last Update
July 4 2016
Active Locations (42)
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1
42
Lille, France
2
41
Mougins, France
3
40
Nîmes, France
4
6
Alzenau in Unterfranken, Germany