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

AbbVie88 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Parkinson Disease (PD)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (13)

University of Calgary /ID# 151948

Calgary, Alberta, Canada

Zeidler Ledcor Centre /ID# 135979

Edmonton, Alberta, Canada

St. Boniface Clinic, CA /ID# 162092

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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)

Time frame: 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.

Time frame: 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).

Time frame: 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)

Time frame: 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).

Time frame: Baseline, Month 3, and every 6 months thereafter up to 48 months

Data from ClinicalTrials.gov

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