Guideline for Hometitration With Duodopa for Parkinson Patients
Pilotstudy to Develop a Guideline for Hometitration With Doudopa for Patients With Parkinson Disease
1 other identifier
observational
10
1 country
1
Brief 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"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 2, 2022
October 1, 2022
5.3 years
June 4, 2019
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient satisfaction
Satisfaction questionnaire specific for study. 10 questions with a scale from highly satisfied to not at all satisfied.
14 days after titration
Secondary Outcomes (6)
Hoehn Yahr staging of Parkinson's disease
2 month
Montreal Cognitive Assesment (MOCA)
2 month
Parkinsons Disease Questionnaire 39 (PD-Q39)
2 month
Unified Parkinsons Disease Rating Scale III (UPDRS)
2 month
Barthel-20 index
2 month
- +1 more secondary outcomes
Interventions
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
Eligibility Criteria
Patients with advanced parkinson, reffered to Duodopa treatment.
You may qualify if:
- 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)
You may not qualify if:
- Patients not eligible for Duodopa-treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- AbbViecollaborator
Study Sites (1)
Neurologisk klinik, Rigshospitalet Glostrup
Copenhagen, Glostrup, 2600, Denmark
Related Publications (1)
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.
PMID: 38623494DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Biering-Sørensen, Director
Rigshospitalet, Denmark
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending
Study Record Dates
First Submitted
June 4, 2019
First Posted
December 12, 2019
Study Start
March 1, 2017
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10