Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in patients with PD treated with Duodopa®. This is in search for an optimal diet that will accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and thus improve motor function and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Oct 2014
Longer than P75 for not_applicable parkinson-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 24, 2014
October 1, 2014
3 years
October 22, 2014
October 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
quality of life
CGI, PDQ-39
4 months
dyskinesias
AIMS
4 months
Secondary Outcomes (2)
fluctuations
4 months
motor function
4 months
Study Arms (2)
PD patients- Diet B first
ACTIVE COMPARATORPatients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet B and then crossover to diet C.
PD patients- Diet C first
ACTIVE COMPARATORPatients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet C and then crossover to diet B.
Interventions
3 different diets: A\\B\\C
Eligibility Criteria
You may qualify if:
- Patients treated with Duodopa at least three months and are stable on medical therapy
- Patients should be not demented, able to fill diaries and to sign an informed consent
You may not qualify if:
- Severe dementia
- Inability to fill out diaries
- Unstable mediated condition
- Chronic renal failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Tel Aviv Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sharon Hassin, Dr
Sheba Medical Center
- PRINCIPAL INVESTIGATOR
Oren Cohen, Dr
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 22, 2014
First Posted
October 24, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
October 24, 2014
Record last verified: 2014-10