UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018031 |
|---|---|
| Receipt number | R000020889 |
| Scientific Title | Systemic inflammation and motor prognosis in Parkinson disease: a retrospective study |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/06/29 15:35:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Systemic inflammation and motor prognosis in Parkinson disease: a retrospective study
Acronym
Inflammation-PD study
Scientific Title
Systemic inflammation and motor prognosis in Parkinson disease: a retrospective study
Scientific Title:Acronym
Inflammation-PD study
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the longitudinal effect of the baseline CRP concentrations on motor prognosis of Parkinson disease (PD).
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure was the change of the Unified PD Rating Scale Part III scores (on period) from the study enrollment to each of the five follow-up periods (the Day 1-90, 91-270, 271-450, 451-630, and 631-900).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with PD who fulfilled the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria (steps 1 and 2), who were admitted to the Department of Neurology of National Regional Center for Neurological Disorders and National Hospital of Utano between January 2008 and December 2013. Subjects with both of the following conditions were included. (i) Plasma concentrations of high-sensitivity CRP for screening blood test were measured in the period when patients were not diagnosed as having any infections. (ii) Modified Hoehn and Yahr stage 4 or less at baseline.
Key exclusion criteria
Subjects with any of the following conditions were excluded. (i) Patients who developed dementia within 1 year of the onset of parkinsonism based on consideration of dementia with Lewy bodies (1-year rule).23 (ii) History of brain surgery. (iii) Having any infections within the one month prior to the enrollment. (iv) Concomitant chronic inflammatory diseases including autoimmune diseases or malignancy. (v) Taking corticosteroids.
Target sample size
192
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sawada |
Organization
Utano National Hospital
Division name
Clinical Research Center
Zip code
Address
8 Ondoyamacho, Narutaki, Ukyoku, Kyoto
TEL
81-75-461-5121
sawada@unh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sawada |
Organization
Utano National Hospital
Division name
Clinical Research Center
Zip code
Address
8 Ondoyamacho, Narutaki, Ukyoku, Kyoto
TEL
81-75-461-5121
Homepage URL
sawada@unh.hosp.go.jp
Sponsor or person
Institute
Utano National Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Center, Utano National Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under review.
Management information
Registered date
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020889
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2015/06/29 | PD_crp data set.xlsx |
