INfusion VErsus STimulation in Parkinson's Disease
NCT02480803, Phase 4, Completed, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | INfusion VErsus STimulation in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT02480803 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 51 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ClinicalTrials.gov |
| Conditions | Parkinson's Disease | ClinicalTrials.gov |
| Interventions | Continuous intrajejunal infusion of levodopa-carbidopa, deep brain stimulation | ClinicalTrials.gov |
| First posted | 2015-06-25 | ClinicalTrials.gov |
| Last updated | 2024-02-13 | ClinicalTrials.gov |
| Other registries' IDs | eudract:2014-004501-32 | ClinicalTrials.gov |
Registered outcomes 42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cost effectiveness in costs per changed unit on PDQ-39 | 12 months | The costs per changed unit on the PDQ-39. | ClinicalTrials.gov |
| Primary | Cost-utility in costs per changed Quality Adjusted Life Year (QALY, years) | 12 months | The costs per QALY. The EuroQol 5D-3L (EQ-5D; 5 questions, each score 1-3, providing a health state, to be translated with provided Valuation set) will be applied as the utility measure. | ClinicalTrials.gov |
| Secondary | Quality of life (on PDQ-39) | 12, 24 and 36 months | Changes from Baseline on Parkinson's Disease Questionnaire-39 (PDQ-39; score 0-100, higher score is lower quality of life) | ClinicalTrials.gov |
| Secondary | Quality of life (on EQ-5D) | 12, 24 and 36 months | Change from Baseline on EuroQol 5D-3L (EQ-5D; 5 questions, each score 1-3, providing a health state, to be translated with provided Valuation set) | ClinicalTrials.gov |
| Secondary | Motor symptoms | 12 and 36 months | Score changes from Baseline in off and on state on Movement Disorder Society's Unified Parkinson Disease Rating Scale (MDS-UPDRS part 3; 0-132, high score is more motor symptoms) | ClinicalTrials.gov |
| Secondary | Motor symptoms: time in off and on-state | 12, 24 and 36 months | Change from Baseline in time in off-state, on-state without dyskinesias, on-state without troublesome dyskinesias and on-state with troublesome dyskinesias measured with motor symptom diary | ClinicalTrials.gov |
| Secondary | Motor experiences of daily living | 12, 24 and 36 months | Changes from Baseline on MDS-UPDRS part 2 (Movement Disorder Society's Unified Parkinson Disease Rating Scale (MDS-UPDRS part 2; score 0-52, high score is more worse health) | ClinicalTrials.gov |
| Secondary | Dyskinesia | 12 and 36 months | Change from Baseline on clinical Dyskinesia Rating Scale (CDRS; score 0-28, high score is more dyskinesia) | ClinicalTrials.gov |
| Secondary | PD-medication (levodopa-equivalent dose) | 12, 24 and 36 months | Change from Baseline expressed in levodopa-equivalent dose | ClinicalTrials.gov |
| Secondary | Functional health status | 12, 24 and 36 months | Change from Baseline on Amsterdam Linear Disability Score (ALDS, 29 items; 0-100, high score is high level of functional status) | ClinicalTrials.gov |
| Secondary | Non-motor symptoms (Non Motor Symptom Checklist) | 12, 24 and 36 months | Changes from Baseline on Non Motor Symptom Checklist | ClinicalTrials.gov |
| Secondary | Non-motor symptoms (Rotterdam Symptom Checklist | 12, 24 and 36 months | Change from Baseline on Rotterdam Symptom Checklist | ClinicalTrials.gov |
| Secondary | Non-motor symptoms (SCOPA-AUT) | 12, 24 and 36 months | Change from Baseline on SCOPA-AUT (SCales for Outcomes in PArkinson's Autonomic symptoms; score 0-92, higher score is more symptoms) | ClinicalTrials.gov |
| Secondary | Disability | 12, 24 and 36 months | Change from Baseline in Hoehn and Yahr stage (H\&Y stage; 1-5: a higher score is more disease progression) | ClinicalTrials.gov |
| Secondary | Cognitive functioning | 12 and 36 months | Change from Baseline on Parkinson's Disease Cognition Rating Scale (PD-CRS; 0-134, higher score is a result of better cognitive performance) | ClinicalTrials.gov |
| Secondary | Cognitive functioning Mattis | 12 and 36 months | Change from Baseline in Mattis Dementia Rating score (score 0-144, higher score is better cognitive function) | ClinicalTrials.gov |
| Secondary | Neuropsychologic functioning BNT | 12 and 36 months | Change from Baseline in Boston Naming Test (range 0-30, higher is better) | ClinicalTrials.gov |
| Secondary | Neuropsychologic functioning Letter Fluency | 12 and 36 months | Change from Baseline in Letter Fluency (score 0-100, higher is better) | ClinicalTrials.gov |
| Secondary | Neuropsychologic functioning WAIS IV | 12 and 36 months | Change from Baseline in WAIS IV (Wechsler Adult Intelligence Scale IV - subsection similarities; score 0-36, higher is better) | ClinicalTrials.gov |
| Secondary | Neuropsychologic functioning Reading | 12 and 36 months | Change from Baseline in Dutch Reading Test (0-100, higher is better) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 32005175 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)