NCT02480803CompletedPhase 4
INfusion VErsus STimulation in Parkinson's Disease
Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation
Source: ClinicalTrials.gov · Last updated 13 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 4 May 2015
- Start date
- 19 Dec 2014
- Primary completion date
- 7 Dec 2021
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Parkinson disease
- NCT number
- NCT02480803
- EudraCT number
- 2014-004501-32
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 51
- From 19 Dec 2014 to the primary completion date, 7 Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
- Previous CLI (through a PEG-tube or Nasal Jejuna\| tube);
- Contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for Duodopa;
Other illness
- Other severely disabling disease;
- Dementia or signs of severe cognitive impairment
- Contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
Age
- Age below 18 years
- Pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;
Other
- Hoehn and Yahr stage 5 at the best moment during the day;
- Psychosis;
- Current depression;
- No informed consent;
- Legally incompetent adults;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Academic Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.