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

UCB

Status: Completed

Conditions: Idiopathic Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02227355

PD0013

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

195 participants in 2 patient groups

PD Patients < 70 years of age

Description:

Patients with Parkinson's Disease (PD) \<70 years of age.

PD Patients ≥ 70 years of age

Description:

Patients with Parkinson's Disease (PD) ≥ 70 years of age.