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Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's disease comparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treatment Deep Brain Stimulation;


- candidate number20860
- NTR NumberNTR4881
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2014
- Secondary IDs2014-004501-32 NL51240.018.14
- Public TitleInfusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's disease comparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treatment Deep Brain Stimulation;
- Scientific TitleInfusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's disease comparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treatment Deep Brain Stimulation;
- ACRONYMINVEST
- hypothesisContinuous Intrajejunal Levodopa Infusion is not cost-effective compared to Deep Brain Stimulation
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Deep brain stimulation
- Inclusion criteria- Idiopathic Parkinson's Disease with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry;
- Despite optimal pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonia or bradykinesia;
- A life expectancy of at least two years.
- Exclusion criteria- 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 adults.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate31-aug-2017
- Target number of participants66
- InterventionsContinuous Intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS).
- Primary outcomeThe costs per unit on the PDQ-39 and the costs per QALY for the cost-effectiveness and cost-utility analyses respectively. The EQ-5D will be applied as the utility measure.
- Secondary outcomeSecondary clinical outcomes are quality of life (PDQ-39 at baseline, 9 and 12 months), PD motor symptoms (MDS-UPDRS-score at baseline and 12 months), dyskinesias (CDRS at baseline and 12 months), 3-day motor symptom diary (at baseline and 12 months), non-motor symptoms such as autonomic functions and sleep (Non Motor Symptom Checklist, Rotterdam Symptom Checklist at baseline and 12 months), adverse effects and complications (at every visit), treatment failure (at every visit), stopping treatment, starting with the alternative than initially started treatment, PD-medication (at every visit), disability (Hoehn and Yahr stage at baseline and 12 months), functional health status (ALDS at baseline and 12 months), patient and physician preferences, patient satisfaction, caregiver burden, neuropsychological and psychiatric assessment at baseline and 12 months, and medical and non-medical care costs (iMCQ and iPCQ at every visit).
- Timepoints1 week, 1 month, 3 months, 6 months, 9 months and 12 months after treatment
- Trial web sitewww.investamc.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.M. Dijk
- CONTACT for SCIENTIFIC QUERIESDr. J.M. Dijk
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Medtronic B.V.
- Publications
- Brief summaryRationale: Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson’s disease (PD). Neurologists and patients tend to prefer the more expensive CLI although a scientific rationale is lacking. To determine the optimal treatment in advanced PD, a comparative study of CLI and DBS is warranted.
Hypothesis: We hypothesize that CLI is a more expensive therapy in advanced PD than DBS and that the surplus in costs is not cost-effective with regard to benefits for the patient and caregivers in quality of life, PD symptoms and adverse events.
Objective: To realize a cost-effective treatment strategy in advanced PD.
Study design: Prospective, randomized, open label multicentre trial, with two additional patient preference treatment arms (“patient preference randomized trial”).
Study population: Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, dyskinesias, painful dystonia, or bradykinesia. A total of 66 patients will be randomized, at least 120 patients will be included in the patient preference arms.
Intervention: Patients will be randomized to DBS or CLI. For DBS treatment, 2 electrodes will be implanted in the brain. The electrodes are connected to an implanted pulse generator, which will be placed subcutaneously in the subclavian area. For CLI treatment, a tube will be placed in the jejunum via a percutaneous endoscopic gastrostomy (PEG). This tube is connected to an external pump that delivers the levodopa-gel.
Main study parameters: There are 6 specified assessment visits: at baseline, and 1 week, 3, 6, 9, and 12 months after start of the study treatment. The primary health economic outcomes are the costs per unit on the PDQ-39 and the costs per QALY for the cost-effectiveness and cost-utility analyses, respectively. The EQ-5D will be applied as the utility measure. Among the secondary outcomes are neurological impairments, functional health, care use and perceptions of patients and neurologists regarding both treatments.
- Main changes (audit trail)
- RECORD3-nov-2014 - 25-mrt-2015


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