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

Overview

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2016

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline to end of the Observational Period in Unified Parkinson’s Disease Rating Scale Part II (UPDRS Part II) total score
    • Time Frame: Baseline to end of Observational Period (6 months)
    • 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).

Secondary Measures

  • Change from Baseline to end of the Observational Period in L-dopa dose
    • Time Frame: 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
    • Time Frame: Baseline to end of Observational Period (6 months)
    • 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.
  • 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
    • Time Frame: End of the Observation Period (Month 6)
    • 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.
  • 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)
    • Time Frame: End of the Observation Period (Month 6)
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UCB Biopharma S.P.R.L.
  • Collaborator
    • PRA Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Clinical Trial Call Center, Study Director, +1 877 822 9493 (UCB)

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.