Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease (PD)
- Sponsor
- AbbVie
- Enrollment
- 88
- Locations
- 13
- Primary Endpoint
- Change in participant's motor symptoms
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is an open-label, postmarketing, observational study to document health outcomes, in Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa (levodopa/carbidopa intestinal gel).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with advanced Parkinson's Disease
- •Prescribed Duodopa by his/her treating physician.
Exclusion Criteria
- •Patients who were previously treated with Duodopa.
- •Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of advanced PD.
Outcomes
Primary Outcomes
Change in participant's motor symptoms
Time Frame: Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter up to 48 months
Evaluated via the Unified Parkinson's Disease Rating Scale (UPDRS) Part II, III, V and Part IV items 33-35; items 32 \& 39 modified as per MDS-UPDRS, and the Freezing of Gait Questionnaire (FOGQ).
Change in the Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Evaluated via the Parkinson's Disease Questionnaire (PDQ-39)
Change in caregiver burden
Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Evaluated via the Zarit Care Giver Burden Questionnaire.
Change in the non-motor symptoms.
Time Frame: Baseline, Day 1, Month 3, and very 6 months thereafter up to 48 months
Evaluated via the Non-Motor symptoms Scale (NMS) and the Parkinson's Disease Sleep Scale (PDSS-2).
Change in the cognitive functions.
Time Frame: Baseline, Day 1, and every 12 months thereafter up to 48 months
Evaluated via the Montreal Cognitive Assessment (MoCa).
Change in caregiver work productivity
Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Evaluated by the Work Productivity and Activity Information Questionnaire (WPAI - care giver)
Change in the participant's Healthcare Resource Utilization
Time Frame: Baseline, Month 3, and every 6 months thereafter up to 48 months
Evaluated via the Health Care Resources Utilization Questionnaire (HCRU).