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

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).

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 26, 2020

Arms, Groups and Cohorts

  • DUODOPA patients.
    • Patients starting DUODOPA treatment at time of enrollment.

Clinical Trial Outcome Measures

Primary Measures

  • 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 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 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 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AbbVie Inc., Study Director, AbbVie

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