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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 July 2021 |
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Main ID: |
NCT02485600 |
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Date of registration:
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26/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients
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Scientific title:
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Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE) |
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Date of first enrolment:
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October 19, 2015 |
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Target sample size:
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88 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02485600 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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AbbVie Inc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease (PD)
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Primary Outcome(s)
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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]
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Change in caregiver burden
[Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months]
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Change in caregiver work productivity
[Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months]
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Change in the participant's Healthcare Resource Utilization
[Time Frame: Baseline, Month 3, and every 6 months thereafter up to 48 months]
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Change in participant's motor symptoms
[Time Frame: Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter up to 48 months]
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Change in the non-motor symptoms.
[Time Frame: Baseline, Day 1, Month 3, and very 6 months thereafter up to 48 months]
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Change in the cognitive functions.
[Time Frame: Baseline, Day 1, and every 12 months thereafter up to 48 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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