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

Parkinson Disease (PD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485600
• Other study ID #: P14-506
• Status: Completed
• Start date: October 19, 2015
• Est. completion date: February 26, 2020

Study information

• Verified date: June 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease (PD)

Locations

Country	Name	City	State
Canada	University of Calgary /ID# 151948	Calgary	Alberta
Canada	Zeidler Ledcor Centre /ID# 135979	Edmonton	Alberta
Canada	Hamilton Health Sciences /ID# 148808	Hamilton	Ontario
Canada	Kingston General Hospital /ID# 144942	Kingston	Ontario
Canada	London Health Sciences Centre /ID# 138434	London	Ontario
Canada	McGill Univ HC /ID# 138334	Montreal	Quebec
Canada	CHUM - Notre-Dame Hospital /ID# 135977	Montréal	Quebec
Canada	The Ottawa Hospital /ID# 135981	Ottawa	Ontario
Canada	CSSS Alphonse-Desjardins, CHAU de Levis /ID# 144941	Quebec City	Quebec
Canada	Ctr Hosp Enfant Jesus /ID# 138435	Quebec City	Quebec
Canada	CHUS - Hopital Fleurimont /ID# 148811	Sherbrooke	Quebec
Canada	Toronto Western Hospital /ID# 135980	Toronto	Ontario
Canada	St. Boniface Clinic, CA /ID# 162092	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in participant's motor symptoms	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).	Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter up to 48 months
Primary	Change in the cognitive functions.	Evaluated via the Montreal Cognitive Assessment (MoCa).	Baseline, Day 1, and every 12 months thereafter up to 48 months
Primary	Change in the Parkinson's Disease Questionnaire (PDQ-39)	Evaluated via the Parkinson's Disease Questionnaire (PDQ-39)	Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Primary	Change in caregiver burden	Evaluated via the Zarit Care Giver Burden Questionnaire.	Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Primary	Change in the non-motor symptoms.	Evaluated via the Non-Motor symptoms Scale (NMS) and the Parkinson's Disease Sleep Scale (PDSS-2).	Baseline, Day 1, Month 3, and very 6 months thereafter up to 48 months
Primary	Change in caregiver work productivity	Evaluated by the Work Productivity and Activity Information Questionnaire (WPAI - care giver)	Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Primary	Change in the participant's Healthcare Resource Utilization	Evaluated via the Health Care Resources Utilization Questionnaire (HCRU).	Baseline, Month 3, and every 6 months thereafter up to 48 months

External Links

•   clinical study report synopsis