UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024854
Receipt No. R000028592
Scientific Title Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis
Date of disclosure of the study information 2016/11/16
Last modified on 2017/07/23

* 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 Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis
Acronym Clinical study for the anti-oxidative stress by edaravone in ALS
Scientific Title Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis
Scientific Title:Acronym Clinical study for the anti-oxidative stress by edaravone in ALS
Region
Japan

Condition
Condition Amyotrophic Lateral Sclerosis (ALS)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effects of anti-oxidative stress of edaravone in ALS patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes We evaluate the effects of edaravone for oxidative stress, anti-oxidative stress and vascular endothelial function in ALS patients.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Edaravone treatment for ALS patients
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
75 years-old >=
Gender Male and Female
Key inclusion criteria ALS patients diagnosed as ALS definite, ALS probable, or probable ALS laboratory supported in EI Escorial arranged Airie House diagnosis criteria, with disease duration within 3 years
Key exclusion criteria Severe renal dysfunction (Cr > 3.0 mg/dl) and impossible evaluations for motor functions
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Abe
Organization Okayama university
Division name Dapartment of Neurology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7365
Email yasuyuki@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Ohta
Organization Okayama university
Division name Department of Neurology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7365
Homepage URL
Email yasuyuki@okayama-u.ac.jp

Sponsor
Institute Okayama university
Institute
Department

Funding Source
Organization Okayama university
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
2016 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 16 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
2016 Year 11 Month 15 Day
Last modified on
2017 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028592

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.