Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02289729
• Date of registration: 10/11/2014
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease ADEQUA
• Scientific title: Study on Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease
• Date of first enrolment: October 2014
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02289729
• Study type: Observational

Countries of recruitment

Spain

Contacts

• Name: Francesc Valldeoriola, MD
• Affiliation: Hospital Clinic of Barcelona

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Primary Outcome(s)

Change From Baseline in PDQ-39 Activities of Daily Living Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in PDQ-39 Bodily Discomfort Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in PDQ-39 Emotional Well-Being Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in PDQ-39 Mobility Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in PDQ-39 Stigma Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in PDQ-39 Communication Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in PDQ-39 Cognition Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in PDQ-39 Social Support Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Secondary Outcome(s)

Change From Baseline in NMSS Gastrointestinal Tract Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in NMSS Mood/Cognition Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Score of the Apathy Scale (AS) to Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Caregiving (Presenteeism) [Time Frame: Baseline, Month 6 (±15 days)]

Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 [Time Frame: Month 6 (±15 days)]

Change From Baseline in Beck Anxiety Inventory (BAI) at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Alertness/Sedation Sub-Scale Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Mean Global Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Social and Leisure Activities at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in NMSS Cardiovascular Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in NMSS Sexual Function Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Composite Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Treatment Effectiveness at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Undesirable Side Effects at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline [Time Frame: Baseline]

Change From Baseline in NMSS Urinary Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Composite Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Caregiving [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in Parkinson Fatigue Scale (PFS-16) at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Calmness/Relaxation Sub-Scale Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Contented/Discontented Sub-Scale Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Caregiving Responsibilities at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in Zarit Burden Interview (ZBI) at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Anxiety Sub-Scale for Caregivers at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in NMSS Attention/Memory Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in NMSS Miscellaneous Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in NMSS Sleep/Fatigue Domain Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Impact on Daily Living Activities at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to Caregiving [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Depression Sub-Scale for Caregivers at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in Beck Depression Inventory, Second Edition (BDI-II) at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Professional Activities at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Caregiver Stress Index (CSI) at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Non-Motor Symptom Scale (NMSS) Global Score at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Medical Care at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Convenience of Use at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline [Time Frame: Baseline]

Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Global Satisfaction at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 [Time Frame: Month 6 (±15 days)]

Change From Baseline in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III): Motor Examination at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) at Month 6 [Time Frame: Baseline, Month 6 (±15 days)]

Secondary ID(s)

P14-335

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02289729