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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-UMIN000001535 |
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Date of registration:
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01/01/2009 |
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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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A multicenter, randomized open trial of ascorbic acid treatment in Charcot-Marie-Tooth disease type 1A
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Scientific title:
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A multicenter, randomized open trial of ascorbic acid treatment in Charcot-Marie-Tooth disease type 1A - CMT-AA |
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Date of first enrolment:
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2005/04/01 |
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Target sample size:
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60 |
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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=R000001855 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase I,II
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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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Masanori Nakagawa |
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Address:
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Kawaramachi Hirokoji, Kajii-chou 465, Kamigyo-ku, Kyoto 602-0841, Japan
Japan |
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Telephone:
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075-251-5793 |
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Email:
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Affiliation:
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Kyoto Prefectural University of Medicine, Graduate School of Medical Science Department of Neurology |
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Name:
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Masanori Nakagawa |
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Address:
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Kawaramachi Hirokoji, Kajii-chou 465, Kamigyo-ku, Kyoto 602-0841, Japan
Japan |
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Telephone:
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075-251-5793 |
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Email:
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mnakagaw@koto.kpu-m.ac.jp |
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Affiliation:
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Kyoto Prefectural University of Medicine, Graduate School of Medical Science Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients with dementia 2) Patients with severe complications 3) Patients who are not appropriate for the trial by the decision of the physician in charge
Age minimum:
15years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Charcot-Marie-Tooth disease 1A
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Intervention(s)
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Ascorbic acid (AA) treatment group (12 weeks oral AA (20mg/kg/day)
no AA treatment group
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Primary Outcome(s)
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An improvement in CMT neuropathy score at baseline, 4, 8 and 12 weeks thereafter.
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Secondary Outcome(s)
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An improvement in muscle strength and ulnar nerve conduction study at baseline, 4, 8 and 12 weeks thereafter.
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Source(s) of Monetary Support
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New treatment strategies for intractable neuropathies based on its pathomechanism. The Research Grant 19A-5 for Nervous and Mental Disorders from the Ministry of Health, Labour and Welfare.
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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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Yes |
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Date Posted:
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Date Completed:
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01/09/2009 |
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URL:
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