Unique ID issued by UMIN | UMIN000004109 |
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Receipt number | R000004944 |
Scientific Title | Effects for an ataxia using low dose betamethasone in patients with Ataxia Telangiectsia. |
Date of disclosure of the study information | 2010/09/30 |
Last modified on | 2016/11/04 13:51:00 |
Effects for an ataxia using low dose betamethasone in patients with Ataxia Telangiectsia.
Low dose betamethasone therapy for Ataxia Telangiectsia.
Effects for an ataxia using low dose betamethasone in patients with Ataxia Telangiectsia.
Low dose betamethasone therapy for Ataxia Telangiectsia.
Japan |
Ataxia Telangiectsia
Neurology | Pediatrics |
Others
NO
The purpose of this clinical study is the elucidation of efficacy of low dose betamethasone for ataxia in patients with Ataxia Telangiectsia.
Safety,Efficacy
Exploratory
Not applicable
Improvement of ataxia evaluated by neurological scale for ataxia
Adverse effects due to steroid, such as glucose intolerance, adrenal function, immunological status, frequency of cancer development and oxidation marker
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Medication;Betamethason(Rinderon)
Medication regimen;
0.02mg/kg/day (per oral) once a day for 20 days. Repeat this regimen with 20 days interval.
Duration of trial; 4 years.
Observation; 5 years.
Not applicable |
20 | years-old | > |
Male and Female
1) Ataxia Telangiectasia
2)<20 years old
3)Performance Status0-2
4)NCI-CTC (National Cancer Institute; Common Toxicity Criteria) Grade I or less
5)one who obtained consent from guardian.
One who obtained consent, if participant is more than 16 years old and communication is available.
1) one who carries infection
2) one who carries serious complication
3) one who carries malignancy
4) one who judged inadequate by investigator
5) one who participated to any clinical trial within past 3 month
5
1st name | |
Middle name | |
Last name | Shuki Mizutani |
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Developmental Biology Section
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
03-5803-5244
smizutani.ped@tmd.ac.jp
1st name | |
Middle name | |
Last name | Masatoshi Takagi |
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Developmental Biology Section
Yushima 1-5-45, Bunkyo-ku, Tokyo
0358035249
m.takagi.ped@tmd.ac.jp
Research group for establishment of diagnostic procedure, Clinical status and etiology for Ataxia Telangiectasia
Ministry of Health, Labor and Welfare, Grant aid for Intractable Diseases
NO
2010 | Year | 09 | Month | 30 | Day |
Unpublished
Completed
2010 | Year | 09 | Month | 30 | Day |
2010 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2015 | Year | 09 | Month | 01 | Day |
2010 | Year | 08 | Month | 27 | Day |
2016 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004944
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