UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination.
Title of the study (Brief title)	Effect of febuxostat and inosine on amyotrophic lateral sclerosis
Region	Japan

Condition
Condition	Amyotrophic lateral sclerosis
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine efficacy and safety of simultaneous administration of febuxostat and inosine for patients with amyotrophic lateral sclerosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference of ALSFRS-R between before and after the treatment
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	Febuxostat 20 mg, Inosine 500 mg, twice a day for 14 days
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Japanese patients with 20 to 80 years of age who are the outpatients of Teikyo University Hospital 2. Patients who have been diagnosed as amyotrophic lateral sclerosis
Key exclusion criteria	1. Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug. 2. Subjects taking azathioprine or mercaptopurine 3. Subject who has or had renal function disorder. 4. Subject with a history of gout, hyperuricemia or urolithiasis. 5. Patients who changed therapeutic drugs and treatment methods within 1 month before administration of test drugs 6. Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size	3

Research contact person
Name of lead principal investigator	Fumiaki Saito
Organization	Teikyo University
Division name	Department of neurology, Faculty of Medicine
Address	11-1, Kaga 2-chome, Itabashi-ku, Tokyo 173-8606, Japan
TEL	03-3964-1211
Email	f-saito@med.teikyo-u.ac.jp

Public contact
Name of contact person	Fumiaki Saito
Organization	Teikyo University
Division name	Department of neurology, Faculty of Medicine
Address	11-1, Kaga 2-chome, Itabashi-ku, Tokyo 173-8606, Japan
TEL	03-3964-1211
Homepage URL
Email	f-saito@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	StaGen CO. LTD
Organization
Division
Category of Funding Organization	Profit organization
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	2018 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 07 Month 18 Day
Last follow-up date
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	2017 Year 09 Month 27 Day
Last modified on	2017 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033501