UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016734
Receipt No. 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

* 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 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
Email 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
Email kenya.nishioka@gmail.com

Sponsor
Institute Department of Neurology, Juntendo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019402

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.