Trial · NCT03693872
Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals
NCT03693872, Not applicable, Completed, Rennes University Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals. Trials, record NCT03693872. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03693872
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals
- NCT number
- NCT03693872
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 43 participants, actual
- Lead sponsor
- Rennes University Hospital
- Conditions
- Parkinson Disease
- Interventions
- Apomorphine, Dopaminergic Agonist + Apomorphine
- First posted
- 2018-10-03
- Last updated
- 2023-11-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up | 6 months | The Non-Motor Symptoms Scale (NMSS) measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease, through 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe). Frequency is rated on a scale from 1 (rarely) to 4 (very frequent). Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms (reduced score). |
| Secondary | Change in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) between the Baseline assessment and the assessment at 6 months' follow up | 6 months | Parkinson's Disease Quality of Life Questionnaire (PDQ-39): the 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD. It is a measure of health status and quality of life, by assessing difficulties in 8 dimensions of daily living: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). The frequency of each event is determined by selecting one of 5 options: never (scored 0) / occasionally (scored 1) / sometimes (2) / often (3) / always (4). Each dimension total score range from 0 to 100, with lower scores reflecting better quality of life. |
| Secondary | Change in the Neurologist Global Impression of change (CGI) between the Baseline assessment and the assessment at 6 months' follow up | 6 months | The Change in the Neurologist (clinician) Global Impression of change (CGI) provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. It ranges from severely impaired to dramatically improved. |
| Secondary | Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the Baseline assessment and the assessment at 6 months' follow up | 6 months | The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part I include 13 items (6 semistructured interview items and 7 self-reported items) scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition. |
| Secondary | Change in apathy assessed on the long version of Lille Apathy Rating Scale between the Baseline assessment and the assessment at 6 months' follow up (LARS) | 6 months | The Lille apathy rating scale (LARS) is a measure of apathy through nine domains (each corresponding to a clinical manifestation of apathy: everyday productivity, interests, taking the initiative, novelty seeking, motivation - Voluntary actions, emotional responses, concern, social life \& self-awareness) and 33 queries. The interview is structured, with a precise scoring mode for each reply (-2 to 2); when an item does not apply to the patient or the reply cannot be classified, it is scored "0" (for non-applicable and/or non-classifiable) The scale's overall score ranges from -36 to +36, with highest scores reflecting apathy severity. 4 factorial sub-scores (intellectual curiosity, emotion, action initiation and self-awareness) are calculated from sub-scale scores. |
| Secondary | Change in occurrence of anxiety (STAI-YA) between the Baseline assessment and the assessment at 6 months' follow up | 6 months | Present feelings |
| Secondary | Change in occurrence of anxiety (STAI-YB) between the Baseline assessment and the assessment at 6 months' follow up | 6 months | General feelings |
| Secondary | Change in behavioral symptoms assessed by Ardouin Scale between the Baseline assessment and the assessment at 6 months' follow up | 6 months | Changes from baseline in hyper and hypo dopaminergic symptoms scores will be assessed through the Ardouin Scale of Behavior in Parkinson's Disease (ASBPD). It is designed for assessing mood and behavior with a view to quantifying changes related to Parkinson's disease, to dopaminergic medication, and to non-motor fluctuations. Its 21 items address nonmotor symptoms and are grouped into four dimensions: general psychological assessment, apathy, nonmotor fluctuations and hyperdopaminergic behaviors, with a 5-point rating scale ranging from 0 (Absent) to 4 (Severe). A score ≥ 2 is considered as a warning sign. |
| Secondary | Change in emotional function assessed by the short form of the TEIQue between the Baseline assessment and the assessment at 6 months' follow upscale | 6 months | The Trait Emotional Intelligence Questionnaire-Short Form (TEIQue-SF) aims at evaluating emotional intelligence through a self-report inventory that measure global trait emotional intelligence (trait EI) through a 30-item questionnaire. The trait EI is about perceptions and not about abilities, competencies or skills ; high scores are not necessarily adaptive (good) and low scores are not necessarily maladaptive (bad). |
| Secondary | Change in emotional function assessed by the short form of the BEQ scale between the Baseline assessment and the assessment at 6 months' follow up | 6 months | The Berkeley Expressivity Questionnaire (BEQ) is a self-report measure of three emotional expressivity facets related to emotional expressivity: expressivity of negative and positive emotions, and strength of expression impulse. Each of the 16 items is answered on a 7-point Likert-type ranging from 1 (strongly disagree) to 7 (strongly agree). The 3 facets can be kept as separate scores or combined to form an overall Emotional Expressivity score. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03693872
GET https://conductscience.org/api/trials/v1/NCT03693872/registered