Parkinson Disease@ctiparkNCT03213379
Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease
A study testing Actimetry measures in people with Parkinson Disease, run by Orkyn'.
Trial summary
The goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do so, the study design includes a patients' randomisation in two groups that will be followed during 6 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Actimetry measures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to 15 Sep 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult suffering from Parkinson's disease aged up to 75 years (included) Patient for whom a first set-up of an apomorphine pump has been decided under medical guidelines Patient who chose the OPTIPARK package (ORKYN nurses) Patient willing to wear the actigraphy bracelet as per the protocol Patient who read, understood and signed the consent form.
Who cannot join
- Patient not willing to take part in the study Patient who had a previous set-up of an apomorphine pump Patient with dementia Dependant patients or patients living in institutional care Patient with a temporary pump of apomorphine compromising a six months follow-up Patient with non-major motor fluctuations Patient already enrolled in an interventional study.
About this study
The goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do so, the study design includes a patients' randomisation in two groups that will be followed during 6 months.
Read the detailed description
The two groups are:
Referent group with one actimetric report at baseline Actimetry group with one actimetric report at baseline and during the follow-up. Using these reports the investigator will be able to modify the prescription of the apomorphin pump without seeing the patient.
It is planned to follow the patients during 6 months of follow-up and 3 medical visits will be conducted as per the standard practice:
1 visit before the installation of the pump
1 visit after the pump installation straight after the patient comes out the hospital
1 visit at 6 months
- Conditions
- Parkinson Disease
- Being tested
- Actimetry measures
- Keywords
- actimeter, apomorphin pump
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actimetry measuresDevice
The patient will wear actigraphy bracelet during a week that will enable to record patients' movements. The report based on the recording will provide an assessment of daytime somnolence and an indication of propensity for impulsive behaviours.The intervention consisted in 2 supplementary actimetry measures and sending of the actimetry reports to the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Referent group | No intervention | The patient of the referent group will have 2 measures of actimetry: A first one at baseline before the apomorphim set-up:the report will be provided to the investigator and a second one before the 6 months follow-up visit but this report will not be provided to the investigator. |
| Actimetry group | Experimental | The patient of the Actimetry group will have at least 4 measures of actimetry and the reports will be all provided to the investigator:
One at baseline before the apomorphim set-up/ the second one 8 days after the hospitalisation/ the third one 28 days after the hospitalisation and the last one before the 6 months follow-up visit One optional measure can be performed 84 days after the hospitalisation. Receives: Device: Actimetry measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump
Proportion of patients with an unscheduled healthcare use during the first 6 months of treatment with the pump (after hospitalization for initiation) including: All medical visits to the neurologist due to the Parkinson disease New hospitalization related to the Parkinson disease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJul 2017 (estimated)
- Primary completion15 Sep 2018 (estimated)
- Study completion15 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orkyn'
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213379
- Sponsor's protocol ID
- P1530
- Other IDs
- Ref ID-RCB
- Acronym
- @ctipark
- Status last verified
- Jul 2017
- First submitted
- 15 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03213379
- Acronym / sponsor ID
- @ctipark / P1530
- Conditions
- Parkinson Disease
- Keywords
- actimeter, apomorphin pump
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Orkyn'Industry (pharma, biotech, devices)
- Study start
- Jul 2017 (estimated)
- Primary completion
- 15 Sep 2018 (estimated)
- Study completion
- 15 Sep 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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.
The goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do so, the study design includes a patients' randomisation in two groups that will be followed during 6 months.
Detailed description
The two groups are:
Referent group with one actimetric report at baseline Actimetry group with one actimetric report at baseline and during the follow-up. Using these reports the investigator will be able to modify the prescription of the apomorphin pump without seeing the patient.
It is planned to follow the patients during 6 months of follow-up and 3 medical visits will be conducted as per the standard practice:
1 visit before the installation of the pump
1 visit after the pump installation straight after the patient comes out the hospital
1 visit at 6 months
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referent group | No intervention | –The patient of the referent group will have 2 measures of actimetry: A first one at baseline before the apomorphim set-up:the report will be provided to the investigator and a second one before the 6 months follow-up visit but this report will not be provided to the investigator. |
| Actimetry group | Experimental | Device: Actimetry measuresThe patient of the Actimetry group will have at least 4 measures of actimetry and the reports will be all provided to the investigator: One at baseline before the apomorphim set-up/ the second one 8 days after the hospitalisation/ the third one 28 days after the hospitalisation and the last one before the 6 months follow-up visit One optional measure can be performed 84 days after the hospitalisation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult suffering from Parkinson's disease aged up to 75 years (included) Patient for whom a first set-up of an apomorphine pump has been decided under medical guidelines Patient who chose the OPTIPARK package (ORKYN nurses) Patient willing to wear the actigraphy bracelet as per the protocol Patient who read, understood and signed the consent form.
Key exclusion criteria (1 listed)
- Patient not willing to take part in the study Patient who had a previous set-up of an apomorphine pump Patient with dementia Dependant patients or patients living in institutional care Patient with a temporary pump of apomorphine compromising a six months follow-up Patient with non-major motor fluctuations Patient already enrolled in an interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actimetry measuresThe patient will wear actigraphy bracelet during a week that will enable to record patients' movements. The report based on the recording will provide an assessment of daytime somnolence and an indication of propensity for impulsive behaviours.The intervention consisted in 2 supplementary actimetry measures and sending of the actimetry reports to the investigator. | Device | Actimetry group |
Primary outcome
Assessment of the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump
Time frame: 6 months
Proportion of patients with an unscheduled healthcare use during the first 6 months of treatment with the pump (after hospitalization for initiation) including: All medical visits to the neurologist due to the Parkinson disease New hospitalization related to the Parkinson disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No. There is no plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Actimetry measures in people with Parkinson Disease, run by Orkyn'.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Assessment of the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump (time frame: 6 months). 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 11 Jul 2017.