Parkinson Disease (PD)NCT02485600
Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients
An observational study of Parkinson Disease (PD), run by AbbVie at 13 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson Disease (PD)
- How many people
- 88 participants
- Where
- 13 sitesCanada
- Study dates
- 19 Oct 2015to 26 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosed with advanced Parkinson's Disease
- Prescribed Duodopa by his/her treating physician.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
University of Calgary /ID# 151948
Calgary, Alberta, T2N 4Z6
Zeidler Ledcor Centre /ID# 135979
Edmonton, Alberta, T6G 2X8
Hamilton Health Sciences /ID# 148808
Hamilton, Ontario, L8L 2X2
Kingston General Hospital /ID# 144942
Kingston, Ontario, K7L 2V7
London Health Sciences Centre /ID# 138434
London, Ontario, N6A 5A5
CHUM - Notre-Dame Hospital /ID# 135977
Montreal, Quebec, H2X 0A9
McGill Univ HC /ID# 138334
Montreal, Quebec, H3G 1A4
The Ottawa Hospital /ID# 135981
Ottawa, Ontario, K1H 8L6
Ctr Hosp Enfant Jesus /ID# 138435
Québec, Quebec, G1J 1Z4
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 144941
Québec, Quebec, G6V 3Z1
CHUS - Hopital Fleurimont /ID# 148811
Sherbrooke, Quebec, J1H 5N4
Toronto Western Hospital /ID# 135980
Toronto, Ontario, M5T 2S8
St. Boniface Clinic, CA /ID# 162092
Winnipeg, Manitoba, R2H 2A5
About this study
Official title: Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)
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).
- Conditions
- Parkinson Disease (PD)
- Keywords
- Cadence, Duodopa, Parkinson's disease, LCIG, Levodopa-carbidopa intestinal gel, Observational
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DUODOPA patients. | Patients starting DUODOPA treatment at time of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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)
Measured: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Change in the participant's Healthcare Resource Utilization
Evaluated via the Health Care Resources Utilization Questionnaire (HCRU).
Measured: Baseline, Month 3, and every 6 months thereafter up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start19 Oct 2015
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485600
- Sponsor's protocol ID
- P14-506
- Status last verified
- Jun 2021
- First submitted
- 26 Jun 2015
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)
- ClinicalTrials.gov ID
- NCT02485600
- Acronym / sponsor ID
- P14-506
- Conditions
- Parkinson Disease (PD)
- Keywords
- Cadence, Duodopa, Parkinson's disease, LCIG, Levodopa-carbidopa intestinal gel, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DUODOPA patients. | – | –Patients starting DUODOPA treatment at time of enrollment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosed with advanced Parkinson's Disease
- Prescribed Duodopa by his/her treating physician.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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)
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.
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).
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease (PD), run by AbbVie at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant's motor symptoms (time frame: Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter up to 48 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.