UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016734 |
|---|---|
| Receipt number | R000019402 |
| Scientific Title | The evaluation of duloxetine effect for the parkinsonism and gait freezing |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2017/12/22 17:13:40 |
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Basic information
Public title
The evaluation of duloxetine effect for the parkinsonism and gait freezing
Acronym
The evaluation of effect of duloxetine and parkinsonism
Scientific Title
The evaluation of duloxetine effect for the parkinsonism and gait freezing
Scientific Title:Acronym
The evaluation of effect of duloxetine and parkinsonism
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will aim to evaluate the efficacy of parkinsonism and gait freezing among the patients with PD. Additionally, we will evaluate the status of depression or degree of pain befor and after treatmens of dloxetine. We select the doublet-blind study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FOG-Q:freezing of gait questionnair
UPDRS:Unified Parkinson's Disease Rating Scale
H & Y; Hoehn and Yahr stage
HDR-S:Hamilton Depression Rating Scale
Beck Score
QIDS-J; Quick Inventory of Depressive Symptomatology
HDS-R; revised Hasegawa's dementia scale
MMSE; Mini-mental scale examination
VAS; Visual Analog Scale
FRS; Face rating scale
WPI; Widespread pain index; from Fibromyalgia diagnostic criteria, ACR2010
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug ; Duloxetine
Duraion; SEP012014-AUG312016
Doseage; 20mg/day or 40mg/day
Times; one time per day P.O.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients are enrolled, who diagnosed clinically Parkinson's disease, complicated with depressive states, freezing gait, or chronic pain.
Key exclusion criteria
The patinets adopted exclusion criteria
1, succidal tendency, severe depression.
2, Severe renal or liver dysfunction
3, hypoersensitivity for duloxetine.
4, Taking MAO-B inhibitor
5, complicated cognitive decline; MMSE under 23.
6, Schisophrenia or bipolar disorder
7, Personality disorders
8, eleavated ESR or CRP in blood examination.
9, ANA over 320 times, or Rheumatoid factor over 100 IU/ml.
10, comorbidity of epilepsy or seizure
11, dysuremia, galucoma.
12, alchol abuser
13, attending dcotor judge not to iclude this protocol.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenya Nishioka |
Organization
Department of Neurology, Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
3-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
kenya.nishioka@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenya Nishioka |
Organization
Department of Neurology, Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
3-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
kenya.nishioka@gmail.com
Sponsor or person
Institute
Department of Neurology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 04 | Month | 01 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 08 | Day |
Last modified on
| 2017 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019402
