UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial
Title of the study (Brief title)	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	Hirotaka Iwaki
Organization	Ehime University Hospital
Division name	Clinical neurology and Pharmacology
Address	Shitsukawa 454, Toon, Ehime
TEL	0899605095
Email	h-iwaki@m.ehime-u.ac.jp

Public contact
Name of contact person	Hirotaka Iwaki
Organization	Ehime University Hospital
Division name	Clinical neurology and pharmacology
Address	Shitsukawa 454, Toon, Ehime
TEL	0899605095
Homepage URL
Email	h-iwaki@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018985