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Trial record 26 of 27 for:    PDSS2

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

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ClinicalTrials.gov Identifier: NCT02485600
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Parkinson's Disease (PD)

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)
Actual Study Start Date : October 19, 2015
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in participant's motor symptoms [ Time Frame: 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).

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

  3. Change in the Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months ]
    Evaluated via the Parkinson's Disease Questionnaire (PDQ-39)

  4. Change in caregiver burden [ Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months ]
    Evaluated via the Zarit Care Giver Burden Questionnaire.

  5. Change in the non-motor symptoms. [ Time Frame: 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).

  6. Change in caregiver work productivity [ Time Frame: 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)

  7. Change in the participant's Healthcare Resource Utilization [ Time Frame: Baseline, Month 3, and every 6 months thereafter up to 48 months ]
    Evaluated via the Health Care Resources Utilization Questionnaire (HCRU).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485600


Contacts
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Contact: Nathalie Foucault 514-832-7702 nathalie.foucault@abbvie.com
Contact: Julie Charbonneau 514-832-7197 julie.charbonneau@abbvie.com

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

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02485600     History of Changes
Other Study ID Numbers: P14-506
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Cadence
Duodopa
Advanced Parkinson's disease
LCIG
Levodopa-carbidopa intestinal gel
Observational
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Carbidopa
Levodopa
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors