INfusion VErsus STimulation in Parkinson's Disease (INVEST)
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ClinicalTrials.gov Identifier: NCT02480803 |
Recruitment Status :
Recruiting
First Posted : June 25, 2015
Last Update Posted : January 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Parkinson's Disease | Drug: Continuous intrajejunal infusion of levodopa-carbidopa Device: deep brain stimulation | Phase 4 |
Rationale: Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). As directly comparative studies are lacking, it is unknown whether one of the therapies is more effective. Besides, CLI seems to be more expensive. 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 8 specified assessment visits: at baseline, and 1 week, 3, 6, 9, 12, 24 and 36 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 quality of life, functional health, complications and adverse effects, use of care and perceptions of patients and neurologists regarding both treatments.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation |
Study Start Date : | December 2014 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
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Active Comparator: continuous levodopa infusion
continuous intrajejunal infusion of levodopa-carbidopa
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Drug: Continuous intrajejunal infusion of levodopa-carbidopa
Continuous delivery of levodopa-carbidopa intestinal gel through an intrajejunal percutaneous tube (Duodopa, CLI, CILI)
Other Names:
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Active Comparator: deep brain stimulation
Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN)
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Device: deep brain stimulation
Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN)
Other Names:
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- Cost effectiveness in costs per unit on PDQ-39 [ Time Frame: 12 months ]The costs per unit on the PDQ-39.
- Cost-utility in costs per QALY [ Time Frame: 12 months ]The costs per QALY. The EQ-5D will be applied as the utility measure.
- Change from Baseline in quality of life: changes on PDQ-39 at 12 months [ Time Frame: 12, 24 and 36 months ]Parkinson's Disease Questionnaire-39
- Change from Baseline in quality of life: changes on EQ-5D [ Time Frame: 12, 24 and 36 months ]EQ-5D questionnaire
- Change from Baseline in motor symptoms: score changes in off and on state on MDS-UPDRS [ Time Frame: 12, 24 and 36 months ]MDS-UPDRS part 3, motor symptom diary, clinical dyskinesia rating scale
- Change from Baseline in motor symptoms: changes in off-state, on-state without dyskinesias, on-state without troublesome dyskinesias and on-state with troublesome dyskinesias [ Time Frame: 12, 24 and 36 months ]measured with motor symptom diary
- Change from Baseline in motor symptoms: changes on clinical Dyskinesia Rating Scale [ Time Frame: 12, 24 and 36 months ]clinical dyskinesia rating scale
- Change from Baseline in non-motor symptoms: changes on Non Motor Symptom Checklist [ Time Frame: 12, 24 and 36 months ]Non Motor Symptom Checklist
- Change from Baseline in non-motor symptoms: changes on Rotterdam Symptom Checklist [ Time Frame: 12, 24 and 36 months ]Rotterdam Symptom Checklist
- Change from Baseline in non-motor symptoms: changes on SCOPA-AUT [ Time Frame: 12, 24 and 36 months ]SCOPA-AUT
- Change from Baseline in non-motor symptoms: changes on MDS-UPDRS part 2 [ Time Frame: 12, 24 and 36 months ]MDS-UPDRS part 2
- Number of participants with adverse effects and description of adverse effects at 12 months [ Time Frame: 12, 24 and 36 months ]
- Number of participants with complications and description of complications at 12 months [ Time Frame: 12, 24 and 36 months ]
- Number of participants with treatment failure at 12 months [ Time Frame: 12, 24 and 36 months ]
- Number of participants who stopped treatment at 12 months [ Time Frame: 12, 24 and 36 months ]
- Number of participants with treatment cross-over at 12 months [ Time Frame: 12, 24 and 36 months ]
- Change from Baseline in PD-medication (levodopa-equivalent dose) at 12 months [ Time Frame: 12, 24 and 36 months ]levodopa-equivalent dose
- Change from Baseline in disability: change of Hoehn and Yahr stage [ Time Frame: 12, 24 and 36 months ]Hoehn and Yahr stage
- Change from Baseline in functional health status: changes on AMC Linear Disability Score) [ Time Frame: 12, 24 and 36 months ]The AMC Linear Disability Score
- Change from Baseline in patient satisfaction (questionnaire) [ Time Frame: 12, 24 and 36 months ]questionnaire
- Change from Baseline in patients attitude to treatment on PRO-Likert Scale [ Time Frame: 12, 24 and 36 months ]PRO-Likert Scale
- Change from Baseline in cognition: changes on Mattis Dementia Rating Score [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Mattis Dementia Rating Score
- Change from Baseline in cognition: changes on PD-CRS [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Parkinson's Disease- Cognitive Rating Scale
- Change from Baseline in language: changes on Boston Naming Test [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Dutch version of Boston Naming Test
- Change from Baseline in language: changes on letter fluency test [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Dutch version of letter fluency test
- Change from Baseline in intelligence: changes on WAIS IV [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: WAIS IV
- Change from Baseline in intelligence: changes on Dutch Reading test for Adults [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Dutch Reading test for Adults
- Change from Baseline in memory: changes on 15 word test [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Dutch 15 word test
- Change from Baseline in memory: changes on Rivermead Behavioral Memory Test [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Rivermead Behavioral Memory Test
- Change from Baseline in attention and executive functions: changes on trail making test [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: trail making test
- Change from Baseline in attention and executive functions: changes on Stroop test [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Stroop I, II, III
- Change from Baseline in complex visual perception: changes in judgement of line orientation [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: judgement of line orientation test
- Change from Baseline in constructive skills: changes in ability to draw a Clock drawing [ Time Frame: 12, 24 and 36 months ]Neuropsychologic assessment: Drawing of a clock
- Change from Baseline in psychiatric disease: changes in psychiatric examination [ Time Frame: 12, 24 and 36 months ]psychiatric examination
- Change from Baseline in psychiatric disease: changes on MINI [ Time Frame: 12, 24 and 36 months ]Mini International Neuropsychiatric Interview
- Change from Baseline in psychiatric disease: changes on Columbia Suicide Severity Rating Scale [ Time Frame: 12, 24 and 36 months ]changes in Columbia Suicide Severity Rating Scale
- Change from Baseline in psychiatric disease: changes on Hamilton Anxiety Scale [ Time Frame: 12, 24 and 36 months ]Hamilton Anxiety Scale
- Change from Baseline in psychiatric disease: changes on Hamilton Depression Scale [ Time Frame: 12, 24 and 36 months ]Hamilton Depression Scale
- Medical and non-medical care costs [ Time Frame: 12, 24 and 36 months ]calculation of the costs by means of iMCQ and iPCQ questionnaire
- Change from Baseline in caregiver burden [ Time Frame: 12, 24 and 36 months ]questionnaire
- Change from Baseline in Compulsive Disorders (Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire (QUIP) [ Time Frame: 12, 24 and 36 months ]Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire (QUIP)
- Change from Baseline in apathy (Starkstein's Apathy Scale) [ Time Frame: 12, 24 and 36 months ]Starkstein's Apathy Scale

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480803
Contact: Daniel van Poppelen, MD | +31205663447 | d.vanpoppelen@amc.uva.nl |
Netherlands | |
Academic Medical Center | Recruiting |
Amsterdam, Noord Holland, Netherlands, 1100ZZ | |
Contact: Daniel van Poppelen, MD 0031205663447 invest@amc.nl | |
Contact: Joke M Dijk, MD PhD 0031205669111 j.m.dijk@amc.nl |
Principal Investigator: | Joke M Dijk, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | J.M. Dijk, J.M. Dijk, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT02480803 |
Other Study ID Numbers: |
2014_336 2014-004501-32 ( EudraCT Number ) |
First Posted: | June 25, 2015 Key Record Dates |
Last Update Posted: | January 23, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Parkinson Parkinson's Disease Deep Brain Stimulation |
levodopa-carbidopa Duodopa continuous intrajejunal infusion |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa Carbidopa Carbidopa, levodopa drug combination |
Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Dopamine Agonists |