A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE

• Conditions: Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

• Registration Number: EUCTR2005-002654-21-SE
• Lead Sponsor: Solvay Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients on treatment with Duodopa for at least 12 weeks prior to the study.

2. or Duodopa treatment naïve patients. In this case the following must be fulfilled: The investigator considers changing conventional Parkinson´s disease treatment. The criteria in the Summary of Product Characteristics for Duodopa must be fulfilled.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients suffering from other diseases that, in the opinion of the investigator, might interfere with the study objectives.

2. Patients that, in the opinion of the investigator, is unable to comply with study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to depict, over time, changes in costs and health related quality of life in patients treated with Duodopa. <br><br>;Secondary Objective: To assess quality of life and to study the safety of Duodopa.<br><br>;Primary end point(s): 1. Resource Use (RU): The use (intensity and frequency) of health care resources will be collected at baseline and throughout the study, in order to evaluate cost consequences of treatment with Duodopa.<br><br>2. Delayed disease progression and Utility: The Unified Parkinson’s Disease Rating Scale (UPDRS) will be used to measure (i) the progression of the disease over time and (ii) to elicit preference-based quality of life, or utility.