ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    abbvie cadence
Previous Study | Return to List | Next Study

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

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.
ClinicalTrials.gov Identifier: NCT02485600
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : June 1, 2018
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)

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 1, 2021
Estimated Study Completion Date : April 1, 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

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

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Zeidler Ledcor Centre Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
Univ British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6T 2A1
Canada, Manitoba
St. Boniface Clinic, CA Recruiting
Winnipeg, Manitoba, Canada, R2H 2A5
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Credit Valley Hosp,Trillium Not yet recruiting
Mississauga, Ontario, Canada, L5M 2N1
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
McGill Univ HC Recruiting
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
CHUM - Notre-Dame Hospital Not yet recruiting
Montréal, Quebec, Canada, H2X 0A9
Ctr Hosp Enfant Jesus Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
CSSS Alphonse-Desjardins, CHAU Recruiting
Quebec City, Quebec, Canada, G6V 3Z1
CHUS - Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

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: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
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