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)

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease (PD)

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 151948
    • Edmonton, Alberta, Canada, T6G 2X8
      • Zeidler Ledcor Centre /ID# 135979
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A5
      • St. Boniface Clinic, CA /ID# 162092
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences /ID# 148808
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital /ID# 144942
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre /ID# 138434
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital /ID# 135981
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital /ID# 135980
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill Univ HC /ID# 138334
    • Montréal, Quebec, Canada, H2X 0A9
      • CHUM - Notre-Dame Hospital /ID# 135977
    • Quebec City, Quebec, Canada, G1J 1Z4
      • Ctr Hosp Enfant Jesus /ID# 138435
    • Quebec City, Quebec, Canada, G6V 3Z1
      • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 144941
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS - Hopital Fleurimont /ID# 148811

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
DUODOPA patients.; Patients starting DUODOPA treatment at time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in the cognitive functions.	Evaluated via the Montreal Cognitive Assessment (MoCa).	Baseline, Day 1, and every 12 months thereafter up to 48 months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2015
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Observational; Parkinson's disease; LCIG; Levodopa-carbidopa intestinal gel; Duodopa; Cadence
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P14-506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No