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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02485600

Enrollment

Registered

2015-06-30

Start date

2015-10-19

Completion date

2020-02-26

Last updated

2021-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease (PD)

Keywords

Cadence, Duodopa, Parkinson's disease, LCIG, Levodopa-carbidopa intestinal gel, Observational

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in participant's motor symptoms	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.	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)	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	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.	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	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	Baseline, Month 3, and every 6 months thereafter up to 48 months	Evaluated via the Health Care Resources Utilization Questionnaire (HCRU).

Countries

Canada

Outcome results