Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients
- Conditions
- Parkinson Disease (PD)
- Registration Number
- NCT02485600
- Lead Sponsor
- AbbVie
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Diagnosed with advanced Parkinson's Disease
- Prescribed Duodopa by his/her treating physician.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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 the cognitive functions. Baseline, Day 1, and every 12 months thereafter up to 48 months Evaluated via the Montreal Cognitive Assessment (MoCa).
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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Hamilton Health Sciences /ID# 148808
🇨🇦Hamilton, Ontario, Canada
St. Boniface Clinic, CA /ID# 162092
🇨🇦Winnipeg, Manitoba, Canada
Kingston General Hospital /ID# 144942
🇨🇦Kingston, Ontario, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 144941
🇨🇦Quebec City, Quebec, Canada
London Health Sciences Centre /ID# 138434
🇨🇦London, Ontario, Canada
The Ottawa Hospital /ID# 135981
🇨🇦Ottawa, Ontario, Canada
McGill Univ HC /ID# 138334
🇨🇦Montreal, Quebec, Canada
Ctr Hosp Enfant Jesus /ID# 138435
🇨🇦Quebec City, Quebec, Canada
CHUM - Notre-Dame Hospital /ID# 135977
🇨🇦Montréal, Quebec, Canada
University of Calgary /ID# 151948
🇨🇦Calgary, Alberta, Canada
Zeidler Ledcor Centre /ID# 135979
🇨🇦Edmonton, Alberta, Canada
Toronto Western Hospital /ID# 135980
🇨🇦Toronto, Ontario, Canada
CHUS - Hopital Fleurimont /ID# 148811
🇨🇦Sherbrooke, Quebec, Canada