Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients

Study 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).

Official Title
-----------------
Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)

Conditions
-----------------
Parkinson Disease (PD)

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DUODOPA patients.<br>Patients starting DUODOPA treatment at time of enrollment. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participant's motor symptoms | 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). | Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter up to 48 months | 
| Change in the cognitive functions. | Evaluated via the Montreal Cognitive Assessment (MoCa). | Baseline, Day 1, and every 12 months thereafter up to 48 months | 
| Change in the Parkinson's Disease Questionnaire (PDQ-39) | Evaluated via the Parkinson's Disease Questionnaire (PDQ-39) | Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months | 
| Change in caregiver burden | Evaluated via the Zarit Care Giver Burden Questionnaire. | Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months | 
| Change in the non-motor symptoms. | Evaluated via the Non-Motor symptoms Scale (NMS) and the Parkinson's Disease Sleep Scale (PDSS-2). | Baseline, Day 1, Month 3, and very 6 months thereafter up to 48 months | 
| Change in caregiver work productivity | Evaluated by the Work Productivity and Activity Information Questionnaire (WPAI - care giver) | Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months | 
| Change in the participant's Healthcare Resource Utilization | Evaluated via the Health Care Resources Utilization Questionnaire (HCRU). | Baseline, Month 3, and every 6 months thereafter up to 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cadence, Duodopa, Parkinson's disease, LCIG, Levodopa-carbidopa intestinal gel, Observational