Parkinson DiseaseNCT04196647
Guideline for Hometitration With Duodopa for Parkinson Patients
An observational study of Parkinson Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to 1. Create a guide for hometitration of Duodopa for patients with Parkinson's disease 2. Outline which patients could be considered for "hometitration" Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Home titration
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 30 Jun 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced parkinson, reffered to Duodopa treatment.
Who may be able to join
- Idiopathic Parkinson Disease (UK Parkinson's Disease Society Brain Bank criteria-UK PDSBB)
- Patient must be self-sufficient, or have access to support in own home (spouse, nursing home, home-nurse)
- Motivated and comfortable with home treatment and telemedicine (tablet provided by the clinic)
Who cannot join
- Patients not eligible for Duodopa-treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Neurologisk klinik, Rigshospitalet Glostrup
Copenhagen, Glostrup, 2600
About this study
Official title: Pilotstudy to Develop a Guideline for Hometitration With Doudopa for Patients With Parkinson Disease
The purpose of this study is to
- Create a guide for hometitration of Duodopa for patients with Parkinson's disease
- Outline which patients could be considered for "hometitration"
Read the detailed description
To start treatment with continuous intestinal levodopa infusion to the duodenum (Duodopa-pump) in patients with Idiopathic Parkinson Disease (IPD), it is usually required that the patient is hospitalised to test if Duodopa works for the patient and for the titration process to find the relevant dosage before operation and connection of the pump.
A hospitalisation is very costly. Experience shows, that this group of patients are often very stressed during hospitalisation because of noise, impaired sleep and unfamiliar surroundings. These conditions make fast and effective dosage titration very difficult, and experience also shows that the dosage often needs to be recalibrated once the patient is back home in familiar surroundings.
The use of TeleMedicin (TM) is on the rise in Denmark as well as other international health care systems.
These factors were the basis for the home-titration study where patients have their initial dosage titration done in their own home, supported by one visit from nursing staff, and one TM (video consultation) a day. The goal is to make the titration process more effective, reduce cost by treating the patient in their own home and making the patient more satisfied with the titration process.
- Conditions
- Parkinson Disease
- Being tested
- Home titration
- Keywords
- Parkinson disease, duodopa, pump, tele-medicine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home titrationOther
Patients have their initial dosage titration of duodopa done in their own home, supported by one visit from nursing staff, and one video consultation a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Satisfaction questionnaire specific for study. 10 questions with a scale from highly satisfied to not at all satisfied.
Measured: 14 days after titration
Secondary outcomes (6)
Hoehn Yahr staging of Parkinson's disease
Scale to acces severity of symptoms of Parkinsons disease.
- Unilateral involvement only usually with minimal or no functional disability Unilateral involvement only 1.5 - Unilateral and axial involvement
- Bilateral or midline involvement without impairment of balance Bilateral involvement without impairment of balance 2.5 - Mild bilateral disease with recovery on pull test
- Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent Mild to moderate bilateral disease; some postural instability; physically independent
- Severely disabling disease; still able to walk or stand unassisted Severe disability; still able to walk or stand unassisted
- Confinement to bed or wheelchair unless aided Wheelchair bound or bedridden unless aided
Measured: 2 month
Montreal Cognitive Assesment (MOCA)
Version 7.0, www.mocatest.org. Maximum points 30 (no sign of cognitive malfunction.
Measured: 2 month
Parkinsons Disease Questionnaire 39 (PD-Q39)
39 questions for the patients to rate QoL in Parkinson's Disease.
Measured: 2 month
Unified Parkinsons Disease Rating Scale III (UPDRS)
Scale on assesment of severity of disease induced symptoms. A total of 199 points represents the worst (total) disability.
Measured: 2 month
Barthel-20 index
Version 30/11-2017, Maximum score 20.
Measured: 2 month
Non-Motor Symptom Scale (NMSS)
Scale to identify non-motor symptoms within 9 domains, score fra 0 to 3, where 0 are no symptoms in that area and 3 is severe.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Mar 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Bo Biering-Soerensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo Biering-Sørensen, Director, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196647
- Sponsor's protocol ID
- 15010036
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thomsen TH, Nielsen NS, Isenberg AL, Moller MH, Clausen JB, Schack Frederiksen IM, Olsen L, Javidi M, Vilhelmsen J, Olsen MK, Biering-Sorensen B. Home-Based Titration with Duodenal Infusion of Levodopa-Carbidopa Intestinal Gel in People with Parkinson's Disease: An Observational Feasibility Study. Parkinsons Dis. 2024 Apr 8;2024:5522824. doi: 10.1155/2024/5522824. eCollection 2024.
PubMed 38623494
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilotstudy to Develop a Guideline for Hometitration With Doudopa for Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04196647
- Acronym / sponsor ID
- 15010036
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, duodopa, pump, tele-medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Dec 2019 (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 purpose of this study is to
- Create a guide for hometitration of Duodopa for patients with Parkinson's disease
- Outline which patients could be considered for "hometitration"
Detailed description
To start treatment with continuous intestinal levodopa infusion to the duodenum (Duodopa-pump) in patients with Idiopathic Parkinson Disease (IPD), it is usually required that the patient is hospitalised to test if Duodopa works for the patient and for the titration process to find the relevant dosage before operation and connection of the pump.
A hospitalisation is very costly. Experience shows, that this group of patients are often very stressed during hospitalisation because of noise, impaired sleep and unfamiliar surroundings. These conditions make fast and effective dosage titration very difficult, and experience also shows that the dosage often needs to be recalibrated once the patient is back home in familiar surroundings.
The use of TeleMedicin (TM) is on the rise in Denmark as well as other international health care systems.
These factors were the basis for the home-titration study where patients have their initial dosage titration done in their own home, supported by one visit from nursing staff, and one TM (video consultation) a day. The goal is to make the titration process more effective, reduce cost by treating the patient in their own home and making the patient more satisfied with the titration process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced parkinson, reffered to Duodopa treatment.
Key inclusion criteria (3 listed)
- Idiopathic Parkinson Disease (UK Parkinson's Disease Society Brain Bank criteria-UK PDSBB)
- Patient must be self-sufficient, or have access to support in own home (spouse, nursing home, home-nurse)
- Motivated and comfortable with home treatment and telemedicine (tablet provided by the clinic)
Key exclusion criteria (1 listed)
- Patients not eligible for Duodopa-treatment
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 |
|---|---|---|
| Home titrationPatients have their initial dosage titration of duodopa done in their own home, supported by one visit from nursing staff, and one video consultation a day | Other | – |
Primary outcome
Patient satisfaction
Time frame: 14 days after titration
Satisfaction questionnaire specific for study. 10 questions with a scale from highly satisfied to not at all satisfied.
6 secondary outcomes
Hoehn Yahr staging of Parkinson's disease
Time frame: 2 month
Montreal Cognitive Assesment (MOCA)
Time frame: 2 month
Parkinsons Disease Questionnaire 39 (PD-Q39)
Time frame: 2 month
Unified Parkinsons Disease Rating Scale III (UPDRS)
Time frame: 2 month
Barthel-20 index
Time frame: 2 month
Non-Motor Symptom Scale (NMSS)
Time frame: 2 month
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 2 Nov 2022.
- Derived from this study: PubMed 38623494Thomsen TH, Nielsen NS, Isenberg AL, Moller MH, Clausen JB, Schack Frederiksen IM, Olsen L, Javidi M, Vilhelmsen J, Olsen MK, Biering-Sorensen B. Home-Based Titration with Duodenal Infusion of Levodopa-Carbidopa Intestinal Gel in People with Parkinson's Disease: An Observational Feasibility Study. Parkinsons Dis. 2024 Apr 8;2024:5522824. doi: 10.1155/2024/5522824. eCollection 2024.
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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.
Bo Biering-Sørensen, Director principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site 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, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Patient satisfaction (time frame: 14 days after titration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196647, which also lists 1 linked publication.
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 2 Nov 2022.