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.
Conditions
Interventions
Trade Name: Duodopa intestinal gel
Pharmaceutical Form: Gastroenteral suspension
INN or Proposed INN: Levodopa
CAS Number: 59-92-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Solvay Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to depict, over time, changes in costs and health related quality of life in patients treated with Duodopa. ;Secondary Objective: To assess quality of life and to study the safety of Duodopa. ;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. 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. | — |
Countries
Sweden
Outcome results
None listed