Clinical trial NCT02289729: Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease
Official title: Study on Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Duodopa
Advanced Parkinson's Disease
Levodopa/Carbidopa intestinal gel
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Parkinson's Disease patients

Brief summary: Patient reported outcomes (PRO) have become an important endpoint assessed in clinical trials. It is important to understand the relationship between medication and patients' symptomatology, quality of life and well-being. We predict levodopa/carbidopa intestinal gel (LCIG; Duodopa) will significantly improve quality of life and emotional well-being compared to baseline in patients with advance Parkinson disease (APD) not well controlled with conventional treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced levodopa-responsive Parkinson's disease, with at least, 2 hours "off" time or 2 hours of dyskinesia based on clinician's/investigator's medical judgment
* Patients with advanced Parkinson's disease with severe motor fluctuations and dyskinesia when combination of conventional PD treatments was unable to satisfactory control symptoms.
* Patients with advanced Parkinson's disease who meet the criteria for use of Levodopa/Carbidopa Intestinal Gel (LCIG) established in the summary of product characteristics, Spanish Neurology Society (SEN) guidelines, local/regional directories (CCAA) or site's protocols for use of LCIG in common clinical practice.
* The decision to treat with LCIG is made by the physician prior to any decision to approach the patient to participate in this study.
* Patients with a cognitive level enough to complete the questionnaires, confirmed by a Mini-mental state examination (MMSE) score of at least 26 points, according to the recommendation of the Movement Disorder Society (MDS) task force on dementia in Parkinson's Disease (PD)

Exclusion Criteria:

* LCIG's contraindications included in the Summary of Product Characteristics (product label)

Primary outcomes:
measure: Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Mobility Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Activities of Daily Living Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Emotional Well-Being Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Stigma Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Social Support Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Cognition Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Communication Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in PDQ-39 Bodily Discomfort Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
Secondary outcomes:
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III): Motor Examination at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Non-Motor Symptom Scale (NMSS) Global Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Cardiovascular Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Sleep/Fatigue Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Mood/Cognition Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Attention/Memory Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Gastrointestinal Tract Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Urinary Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Sexual Function Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in NMSS Miscellaneous Domain Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Mean Global Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Alertness/Sedation Sub-Scale Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Contented/Discontented Sub-Scale Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Calmness/Relaxation Sub-Scale Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in Parkinson Fatigue Scale (PFS-16) at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Score of the Apathy Scale (AS) to Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in Beck Depression Inventory, Second Edition (BDI-II) at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in Beck Anxiety Inventory (BAI) at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Composite Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Undesirable Side Effects at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Treatment Effectiveness at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Convenience of Use at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Impact on Daily Living Activities at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Medical Care at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Global Satisfaction at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Composite Score at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Professional Activities at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Social and Leisure Activities at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Caregiving Responsibilities at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in Zarit Burden Interview (ZBI) at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in the Caregiver Stress Index (CSI) at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Depression Sub-Scale for Caregivers at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Anxiety Sub-Scale for Caregivers at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) at Month 6
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Caregiving (Presenteeism)
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to Caregiving
timeFrame: Baseline, Month 6 (±15 days)
measure: Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Caregiving
timeFrame: Baseline, Month 6 (±15 days)
measure: Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline
timeFrame: Baseline
measure: Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6
timeFrame: Month 6 (±15 days)
measure: Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline
timeFrame: Baseline
measure: Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6
timeFrame: Month 6 (±15 days)
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Francesc Valldeoriola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wetmore JB, Arbelo JM, Catalan MJ, Valldeoriola F, Rodriguez-Blazquez C, Martinez-Martin P. Psychometric Properties of the Apathy Scale in Advanced Parkinson's Disease. Parkinsons Dis. 2019 Mar 28;2019:1965394. doi: 10.1155/2019/1965394. eCollection 2019.