Clinical trial
Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation
Name
2014_336
Description
Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no comparative studies have been executed. The INVEST study is an open label randomised controlled trial with cost-effectiveness as primary outcome. The main clinical outcome is quality of life; secondary outcomes are motor symptoms and neurological impairments, among others.
Trial arms
Trial start
2014-12-19
Estimated PCD
2021-12-07
Trial end
2024-01-26
Status
Completed
Phase
Early phase I
Treatment
Continuous intrajejunal infusion of levodopa-carbidopa
Continuous delivery of levodopa-carbidopa intestinal gel through an intrajejunal percutaneous tube (Duodopa, CLI, CILI)
Arms:
continuous levodopa infusion
Other names:
Duodopa infusion, Intestinal levodopa-carbidopa infusion
deep brain stimulation
Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN)
Arms:
deep brain stimulation
Other names:
DBS, DBS-STN
Size
51
Primary endpoint
Cost effectiveness in costs per changed unit on PDQ-39
12 months
Cost-utility in costs per changed Quality Adjusted Life Year (QALY, years)
12 months
Eligibility criteria
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;
* Other severely disabling disease;
* Dementia or signs of severe cognitive impairment
* 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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}
Updated at
2024-02-13
1 organization
1 product
1 indication
Product
Levodopa-CarbidopaIndication
Parkinson's Disease