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Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease (@ctipark)

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ClinicalTrials.gov Identifier: NCT03213379
Recruitment Status : Unknown
Verified July 2017 by Orkyn'.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Orkyn'

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Actimetry measures Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: A unique code is given to each patient enrolled in the study. Neither the name nor the surname of patient are mentioned.
Primary Purpose: Supportive Care
Official Title: Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apomorphine

Arm Intervention/treatment
No Intervention: Referent group

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.

Experimental: Actimetry group

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.

Device: Actimetry measures
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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Responsible Party: Orkyn'
ClinicalTrials.gov Identifier: NCT03213379    
Other Study ID Numbers: P1530
Ref ID-RCB ( Other Identifier: 2016-A00261-50 )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan

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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 Orkyn':
actimeter
apomorphin pump
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases