N/A
N=59
Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02289729 ↗Enrolled (actual)
59
Serious AEs
30.5%
Results posted
Jan 2019
Primary outcome: Primary: Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6 — -12.81 units on a scale — p=< 0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6 |
-12.81 | < 0.0001 sig |
| PRIMARY Change From Baseline in PDQ-39 Mobility Domain Score at Month 6 |
-16.92 | < 0.0001 sig |
| PRIMARY Change From Baseline in PDQ-39 Activities of Daily Living Domain Score at Month 6 |
-18.43 | < 0.0001 sig |
| PRIMARY Change From Baseline in PDQ-39 Emotional Well-Being Domain Score at Month 6 |
-13.06 | < 0.0001 sig |
| PRIMARY Change From Baseline in PDQ-39 Stigma Domain Score at Month 6 |
-6.85 | 0.0328 sig |
| PRIMARY Change From Baseline in PDQ-39 Social Support Domain Score at Month 6 |
-2.08 | 0.4183 |
| PRIMARY Change From Baseline in PDQ-39 Cognition Domain Score at Month 6 |
-13.22 | < 0.0001 sig |
| PRIMARY Change From Baseline in PDQ-39 Communication Domain Score at Month 6 |
-9.13 | 0.0003 sig |
| PRIMARY Change From Baseline in PDQ-39 Bodily Discomfort Domain Score at Month 6 |
-9.13 | 0.0109 sig |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III): Motor Examination at Month 6 |
-6.51 | 0.0002 sig |
| SECONDARY Change From Baseline in the Non-Motor Symptom Scale (NMSS) Global Score at Month 6 |
-35.75 | < 0.0001 sig |
| SECONDARY Change From Baseline in NMSS Cardiovascular Domain Score at Month 6 |
-1.81 | 0.0002 sig |
| SECONDARY Change From Baseline in NMSS Sleep/Fatigue Domain Score at Month 6 |
-8.73 | < 0.0001 sig |
| SECONDARY Change From Baseline in NMSS Mood/Cognition Domain Score at Month 6 |
-5.83 | 0.0038 sig |
| SECONDARY Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score at Month 6 |
2.12 | < 0.0001 sig |
| SECONDARY Change From Baseline in NMSS Attention/Memory Domain Score at Month 6 |
-1.12 | 0.0274 sig |
| SECONDARY Change From Baseline in NMSS Gastrointestinal Tract Domain Score at Month 6 |
-3.58 | < 0.0001 sig |
| SECONDARY Change From Baseline in NMSS Urinary Domain Score at Month 6 |
-5.19 | 0.0006 sig |
| SECONDARY Change From Baseline in NMSS Sexual Function Domain Score at Month 6 |
-2.94 | 0.0010 sig |
| SECONDARY Change From Baseline in NMSS Miscellaneous Domain Score at Month 6 |
-4.47 | 0.0002 sig |
| SECONDARY Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Mean Global Score at Month 6 |
-6.63 | 0.0297 sig |
| SECONDARY Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Alertness/Sedation Sub-Scale Score at Month 6 |
-7.38 | 0.0279 sig |
| SECONDARY Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Contented/Discontented Sub-Scale Score at Month 6 |
-3.37 | 0.2777 |
| SECONDARY Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Calmness/Relaxation Sub-Scale Score at Month 6 |
-11.58 | 0.0047 sig |
| SECONDARY Change From Baseline in Parkinson Fatigue Scale (PFS-16) at Month 6 |
-0.56 | 0.0003 sig |
| SECONDARY Change From Baseline in the Score of the Apathy Scale (AS) to Month 6 |
-0.52 | <0.5877 |
| SECONDARY Change From Baseline in Beck Depression Inventory, Second Edition (BDI-II) at Month 6 |
-5.15 | 0.0002 sig |
| SECONDARY Change From Baseline in Beck Anxiety Inventory (BAI) at Month 6 |
-6.21 | <0.0001 sig |
| SECONDARY Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Composite Score at Month 6 |
16.15 | < 0.0001 sig |
| SECONDARY Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Undesirable Side Effects at Month 6 |
-25.00 | < 0.0001 sig |
| SECONDARY Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Treatment Effectiveness at Month 6 |
30.39 | < 0.0001 sig |
| SECONDARY Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Convenience of Use at Month 6 |
19.77 | 0.0001 sig |
| SECONDARY Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Impact on Daily Living Activities at Month 6 |
18.75 | < 0.0001 sig |
| SECONDARY Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Medical Care at Month 6 |
4.09 | 0.2428 |
| SECONDARY Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Global Satisfaction at Month 6 |
44.44 | 0.0687 |
| SECONDARY Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Composite Score at Month 6 |
3.21 | 0.3126 |
| SECONDARY Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Professional Activities at Month 6 |
2.55 | 0.1533 |
| SECONDARY Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Social and Leisure Activities at Month 6 |
-0.21 | 0.8145 |
| SECONDARY Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Caregiving Responsibilities at Month 6 |
0.87 | 0.4048 |
| SECONDARY Change From Baseline in Zarit Burden Interview (ZBI) at Month 6 |
-0.32 | 0.8321 |
| SECONDARY Change From Baseline in the Caregiver Stress Index (CSI) at Month 6 |
-0.55 | 0.1945 |
| SECONDARY Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Depression Sub-Scale for Caregivers at Month 6 |
0.20 | 0.7937 |
| SECONDARY Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Anxiety Sub-Scale for Caregivers at Month 6 |
-1.10 | 0.0234 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) at Month 6 |
-7.56 | 0.5922 |
| SECONDARY Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Caregiving (Presenteeism) |
0.00 | 1.000 |
| SECONDARY Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to Caregiving |
-6.69 | 0.6481 |
| SECONDARY Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Caregiving |
-3.33 | 0.6741 |
| SECONDARY Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline |
0.27148; 0.07346; 0.20994; 0.28271; 0.46174; 0.08846 | 0.0389 sig |
| SECONDARY Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 |
0.30902; 0.35220; 0.36814; 0.60620; 0.56325; 0.23657 | 0.0239 sig |
| SECONDARY Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline |
-0.51735; -0.16188; -0.44739; 0.06318; 0.17492; 0.28618 | < 0.0001 sig |
| SECONDARY Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 |
-0.63324; 0.17735; -0.06976; -0.11015; 0.00326; -0.10256 | < 0.0001 sig |
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)
Data sourced from ClinicalTrials.gov (NCT02289729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.