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Trial record 1 of 1 for:    abbvie cadence
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Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02485600
First Posted: June 30, 2015
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
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
Advanced Parkinson's Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in participant's motor symptoms [ Time Frame: Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter ]
    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 non-motor symptoms. [ Time Frame: Baseline, Day 1, Month 3, and very 6 months thereafter ]
    Evaluated via the Non-Motor symptoms Scale (NMS) and the Parkinson's Disease Sleep Scale (PDSS-2).

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

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

  • Change in caregiver work productivity [ Time Frame: Baseline, Day 1, Month 3, and every 6 months thereafter ]
    Evaluated by the Work Productivity and Activity Information Questionnaire (WPAI - care giver)

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

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


Estimated Enrollment: 200
Study Start Date: October 19, 2015
Estimated Study Completion Date: April 1, 2021
Estimated Primary Completion Date: April 1, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
DUODOPA patients.
Patients starting DUODOPA treatment at time of enrollment.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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.

  Contacts and Locations
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
Contact: Nathalie Foucault, BS 514-832-7702 nathalie.foucault@abbvie.com
Contact: Dominique Julien, MS 514-832-7453 dominique.julien@abbvie.com

Locations
Canada
University of Calgary /ID# 135978 Withdrawn
Calgary, Canada, T2N 2T9
University of Calgary /ID# 151948 Recruiting
Calgary, Canada, T2N 4N1
Cross Cancer Institute, University of Alberta /ID# 135979 Recruiting
Edmonton, Canada, T6G 2B7
Hamilton Health Sciences, General Site /ID# 148808 Recruiting
Hamilton, Canada, L8L 2X2
Kingston General Hospital /ID# 144942 Recruiting
Kingston, Canada, K7L 2V7
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 144941 Recruiting
Levis, Canada, G6V 3Z1
London Health Sciences Centre /ID# 138434 Not yet recruiting
London, Canada, N6A 5A5
Credit Valley Hospital, Trillium Health Partners /ID# 169033 Not yet recruiting
Mississaugal, Canada, L5M 2N1
CHUM - Notre-Dame Hospital /ID# 135977 Withdrawn
Montreal, Canada, H2L 4M1
Montreal General Hospital /ID# 138334 Recruiting
Montreal, Canada, H3G 1A4
The Ottawa Hospital Cancer Centre /ID# 135981 Recruiting
Ottawa, Canada, K1Y 4E9
Centre Hospitalier Enfant Jesus /ID# 138435 Recruiting
Quebec City, Canada, G1J 1Z4
Centre Hospitalier universitaire de Sherbrooke (CHUS) /ID# 148811 Recruiting
Sherbrooke, Canada, J1H5N4
Toronto Western Hospital /ID# 135980 Recruiting
Toronto, Canada, M5T 2S8
University of British Columbia /ID# 142014 Not yet recruiting
Vancouver, Canada, V5Z 4E8
University of British Columbia /ID# 168298 Not yet recruiting
Vancouver, Canada, V6T 2B5
Vancouver Hospital & Health Science Center /ID# 138436 Withdrawn
Vancouver, Canada, V6T 2B5
Sponsors and Collaborators
AbbVie
Investigators
Study Director: George Wielgosz, MS Abbvie Corporation
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02485600     History of Changes
Other Study ID Numbers: P14-506
First Submitted: June 26, 2015
First Posted: June 30, 2015
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
LCIG
Duodopa
Parkinson's disease
Observational
Cadence
Levodopa-carbidopa intestinal gel

Additional relevant MeSH terms:
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