Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatments
- Conditions
- Patients with advanced PD who's motor symptoms — severe responsefluctuations, dyskinesias, painful dystonia and / or bradykinesia —cannot be controlled despite optimal oral pharmacological therapy.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-004501-32-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
1. idiopathic PD with bradykinesia and at least two of the following
signs; resting tremor, rigidity, and asymmetry;
2. despite optimal pharmacological treatment at least one of the
following symptoms: severe response fluctuations, dyskinesias, painful
dystonia, or bradykinesia;
3. a life expectancy of more than two years.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
age below 18 years
- previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
- previous CLI (through a PEG-tube or Nasal Jejuna| tube);
- Hoehn and Yahr stage 5 at the best moment during the day;
-a Montreal Cognitive Assessment score of 25 or less (MOCA; http://www.mocatest.org);
-psychosis;
- current depression;
- contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
- contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for
Duodopa;
- pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;
- No informed consent;
- legally incompetent adult
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to realize an efficient allocation of resources to the available treatment options in advanced<br>PD, while guaranteeing the highest standard of care.<br>;Secondary Objective: Secondary objectives are<br>1) to quantify the need for and cost of healthcare and the health benefits in both groups<br>2) to assess the patients motor and non-motor symptoms, quality of life and daily functioning in both DBS and CLI<br>3) to register and compare adverse effects and complications in both groups and verify patients’ and treating physicians’<br>conceptions about the different treatments;Primary end point(s): The main parameters are the costs per unit on the PDQ-39 and the costs per<br>QALY ;Timepoint(s) of evaluation of this end point: At 12 months after start of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary clinical outcomes are quality of life (PDQ-39), PD motor symptoms (MDS-UPDRS), dyskinesias (CDRS), 3-day<br>motor symptom diary),adverse effects and complications, treatment failure, non-motor symptoms such as autonomic<br>functions and sleep (Non Motor Symptom Checklist, Rotterdam Symptom Checklist), PD-medication, disability,<br>functional health status (ALDS), patient and physician preferences, patient satisfaction, caregiver burden,<br>neuropsychological and psychiatric assessment, stopping treatment, starting with the alternative than initially started<br>treatment, and medical and non-medical care costs (iMCQ, iPCQ). ;Timepoint(s) of evaluation of this end point: At 12 months after start of treatment