ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000016352
Date of registration:	01/02/2015
Prospective Registration:	Yes
Primary sponsor:	Ehime University Hospital
Public title:	The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial
Scientific title:	The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial - The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis
Date of first enrolment:	2015/02/01
Target sample size:	10
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018985
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Phase I,II

Countries of recruitment
Japan

Contacts

Name:	Hirotaka Iwaki
Address:	Shitsukawa 454, Toon, Ehime Japan
Telephone:	0899605095
Email:	h-iwaki@m.ehime-u.ac.jp
Affiliation:	Ehime University Hospital Clinical neurology and pharmacology

Name:	Hirotaka Iwaki
Address:	Shitsukawa 454, Toon, Ehime Japan
Telephone:	0899605095
Email:	h-iwaki@m.ehime-u.ac.jp
Affiliation:	Ehime University Hospital Clinical neurology and Pharmacology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Severe kidney failure Past history with hyper-reaction against Edaravone Physician's opinion against participation

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

amyotrophic lateral sclerosis

Intervention(s)

edaravone

Primary Outcome(s)

Adverse effects leading discontinuation of the medication

Secondary Outcome(s)

1. Respiratory volume 2. ALSFRS: Amyotrophic Lateral Screlosis Functional Rating Scale

Secondary ID(s)

Source(s) of Monetary Support

Ehime University Hospital

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	03/08/2016
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.