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

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ClinicalTrials.gov Identifier: NCT02485600
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):

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).

Condition or disease
Advanced Parkinson's Disease

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)
Study Start Date : October 19, 2015
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change in participant's motor symptoms [ Time Frame: Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter ]
    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 non-motor symptoms. [ Time Frame: Baseline, Day 1, Month 3, and very 6 months thereafter ]
    Evaluated via the Non-Motor symptoms Scale (NMS) and the Parkinson's Disease Sleep Scale (PDSS-2).

  3. Change in the participant's Healthcare Resource Utilization [ Time Frame: Baseline, Month 3, and every 6 months thereafter ]
    Evaluated via the Health Care Resources Utilization Questionnaire (HCRU).

  4. Change in the Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter ]
    Evaluated via the Parkinson's Disease Questionnaire (PDQ-39)

  5. Change in caregiver work productivity [ Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter ]
    Evaluated by the Work Productivity and Activity Information Questionnaire (WPAI - care giver)

  6. Change in caregiver burden [ Time Frame: Baseline, Day 1 , Month 3, and every 6 months thereafter ]
    Evaluated via the Zarit Care Giver Burden Questionnaire.

  7. Change in the cognitive functions. [ Time Frame: Baseline, Day 1, and every 12 months thereafter ]
    Evaluated via the Montreal Cognitive Assessment (MoCa).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patient population will consist of patients eligible for DUODOPA treatment according to the DUODOPA Product Monograph (DPM) approved by Health Canada and according to the reimbursement criteria accepted by the Canadian Provincial Health Authorities or private insurance companies.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485600

Contact: Nathalie Foucault, BS 514-832-7702 nathalie.foucault@abbvie.com
Contact: Dominique Julien, MS 514-832-7453 dominique.julien@abbvie.com

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Centre Hospitalier Enfant Jesus /ID# 138435 Recruiting
Quebec City, Canada, G1J 1Z4
Centre Hospitalier universitaire de Sherbrooke (CHUS) /ID# 148811 Recruiting
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Toronto Western Hospital /ID# 135980 Recruiting
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University of British Columbia /ID# 142014 Not yet recruiting
Vancouver, Canada, V5Z 4E8
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Vancouver Hospital & Health Science Center /ID# 138436 Withdrawn
Vancouver, Canada, V6T 2B5
Sponsors and Collaborators
Study Director: George Wielgosz, MS Abbvie Corporation

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02485600     History of Changes
Other Study ID Numbers: P14-506
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
Parkinson's disease
Levodopa-carbidopa intestinal gel

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors