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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DUODOPA patients. | Patients starting DUODOPA treatment at time of enrollment. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary /ID# 151948 | Calgary | Alberta | T2N 4Z6 | Canada | ||
| Zeidler Ledcor Centre /ID# 135979 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Evaluated via the Health Care Resources Utilization Questionnaire (HCRU). |
| Baseline, Month 3, and every 6 months thereafter up to 48 months |
| Edmonton |
| Alberta |
| T6G 2X8 |
| Canada |
| St. Boniface Clinic, CA /ID# 162092 | Winnipeg | Manitoba | R2H 2A5 | Canada |
| Hamilton Health Sciences /ID# 148808 | Hamilton | Ontario | L8L 2X2 | Canada |
| Kingston General Hospital /ID# 144942 | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre /ID# 138434 | London | Ontario | N6A 5A5 | Canada |
| The Ottawa Hospital /ID# 135981 | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto Western Hospital /ID# 135980 | Toronto | Ontario | M5T 2S8 | Canada |
| CHUM - Notre-Dame Hospital /ID# 135977 | Montreal | Quebec | H2X 0A9 | Canada |
| McGill Univ HC /ID# 138334 | Montreal | Quebec | H3G 1A4 | Canada |
| Ctr Hosp Enfant Jesus /ID# 138435 | Québec | Quebec | G1J 1Z4 | Canada |
| CSSS Alphonse-Desjardins, CHAU de Levis /ID# 144941 | Québec | Quebec | G6V 3Z1 | Canada |
| CHUS - Hopital Fleurimont /ID# 148811 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |