Clinical trial NCT02485600: Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients
Official title: Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease (PD)
Keywords: Cadence
Duodopa
Parkinson's disease
LCIG
Levodopa-carbidopa intestinal gel
Observational
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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.

Primary outcomes:
measure: Change in participant's motor symptoms
timeFrame: Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter up to 48 months
measure: Change in the cognitive functions.
timeFrame: Baseline, Day 1, and every 12 months thereafter up to 48 months
measure: Change in the Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
measure: Change in caregiver burden
timeFrame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
measure: Change in the non-motor symptoms.
timeFrame: Baseline, Day 1, Month 3, and very 6 months thereafter up to 48 months
measure: Change in caregiver work productivity
timeFrame: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
measure: Change in the participant's Healthcare Resource Utilization
timeFrame: Baseline, Month 3, and every 6 months thereafter up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary /ID# 151948
state: Alberta
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre /ID# 135979
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface Clinic, CA /ID# 162092
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences /ID# 148808
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital /ID# 144942
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre /ID# 138434
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital /ID# 135981
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital /ID# 135980
state: Ontario
city: Montreal
country: Canada
facility: McGill Univ HC /ID# 138334
state: Quebec
city: Montréal
country: Canada
facility: CHUM - Notre-Dame Hospital /ID# 135977
state: Quebec
city: Quebec City
country: Canada
facility: Ctr Hosp Enfant Jesus /ID# 138435
state: Quebec
city: Quebec City
country: Canada
facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 144941
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 148811
state: Quebec
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: