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OpenTrials
Completed

NCT Number: NCT02485600

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

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).

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Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary /ID# 151948, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  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).

  3. 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)

  4. 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.

  5. 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).

  6. 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)

  7. 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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2015
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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