Guideline for Hometitration With Duodopa for Parkinson Patients

NCT ID: NCT04196647

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2022-06-30

Brief Summary

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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"

Detailed Description

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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

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Home titration

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Patients not eligible for Duodopa-treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Bo Biering-Soerensen

Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Biering-Sørensen, Director

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Neurologisk klinik, Rigshospitalet Glostrup

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38623494 (View on PubMed)

Other Identifiers

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15010036

Identifier Type: -

Identifier Source: org_study_id

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