UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016352 |
|---|---|
| Receipt number | R000018985 |
| Scientific Title | The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2016/08/03 09:11:38 |
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Basic information
Public title
The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial
Acronym
The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis
Scientific Title
The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial
Scientific Title:Acronym
The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse effects leading discontinuation of the medication
Key secondary outcomes
1. Respiratory volume
2. ALSFRS: Amyotrophic Lateral Screlosis Functional Rating Scale
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
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed ALS, aged equal/over 20 years old.
Key exclusion criteria
Severe kidney failure
Past history with hyper-reaction against Edaravone
Physician's opinion against participation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwaki |
Organization
Ehime University Hospital
Division name
Clinical neurology and Pharmacology
Zip code
Address
Shitsukawa 454, Toon, Ehime
TEL
0899605095
h-iwaki@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwaki |
Organization
Ehime University Hospital
Division name
Clinical neurology and pharmacology
Zip code
Address
Shitsukawa 454, Toon, Ehime
TEL
0899605095
Homepage URL
h-iwaki@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime University Hospital
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 | 02 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 27 | Day |
Last modified on
| 2016 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018985
