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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000029308 |
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Date of registration:
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30/09/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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. - Effect of febuxostat and inosine on amyotrophic lateral sclerosis |
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Date of first enrolment:
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2017/07/18 |
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Target sample size:
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3 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033501 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Fumiaki Saito |
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Address:
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11-1, Kaga 2-chome, Itabashi-ku, Tokyo 173-8606, Japan
Japan |
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Telephone:
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03-3964-1211 |
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Email:
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f-saito@med.teikyo-u.ac.jp |
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Affiliation:
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Teikyo University Department of neurology, Faculty of Medicine |
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Name:
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Fumiaki Saito |
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Address:
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11-1, Kaga 2-chome, Itabashi-ku, Tokyo 173-8606, Japan
Japan |
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Telephone:
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03-3964-1211 |
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Email:
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f-saito@med.teikyo-u.ac.jp |
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Affiliation:
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Teikyo University Department of neurology, Faculty of Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Amyotrophic lateral sclerosis
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Intervention(s)
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Febuxostat 20 mg, Inosine 500 mg, twice a day for 14 days
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Primary Outcome(s)
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Difference of ALSFRS-R between before and after the treatment
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Source(s) of Monetary Support
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StaGen CO. LTD
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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