Unique ID issued by UMIN | UMIN000000474 |
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Receipt number | R000000572 |
Scientific Title | Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) |
Date of disclosure of the study information | 2006/09/01 |
Last modified on | 2009/08/02 15:25:04 |
Double-blind Placebo-controlled Clinical Trial
of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Clinical Trial of Leuprorelin acetate in Patients with SBMA
Double-blind Placebo-controlled Clinical Trial
of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Clinical Trial of Leuprorelin acetate in Patients with SBMA
Japan |
Spinal and bulbar muscular atrophy (SBMA)
Neurology |
Others
NO
To evaluate efficacy and safety of leuprorelin acetate in patient with spinal and bulbar muscular atrophy (SBMA)
Safety,Efficacy
Exploratory
Phase II
Motor function(ALSFRS-R)
Frequency of aspiration pneumonia,
serum creatine kinase, serum testosterone, liver function test, HbA1c, NCV, immunohistological study of scrotal skin biopsy and Respiratory function test.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Leuprorelin acetate 3.75 mg subcutaneous injection every 4 weeks
Placebo subcutaneous injection every 4 weeks
30 | years-old | <= |
70 | years-old | >= |
Male
Genetically confirmed SBMA male patients in Japan who have no desire to father a child with written informed consent.
1) Patients with past medical history of allergy to leuprorelin acetate
2) Patients who have severe complications and are not appropriate to participate to the trial..
3) Patients who have taken testosterone within 8 weeks prior to the informed consent.
40
1st name | |
Middle name | |
Last name | Gen Sobue |
Nagoya University, School of Medicine
Department of Neurology
65 Tsurumai, Showa-ku, Nagoya, Aichi
052-744-2385
1st name | |
Middle name | |
Last name |
Nagoya University, School of Medicine
Department of Neurology
65 Tsurumai, Showa-ku, Nagoya, Aichi
052-744-2390
sbma@med.nagoya-u.ac.jp
Department of Neurology, Nagoya University School of Medicine
Grant-in-Aid for Scientific Research
Japan
NO
2006 | Year | 09 | Month | 01 | Day |
Published
Completed
2003 | Year | 07 | Month | 01 | Day |
2003 | Year | 09 | Month | 01 | Day |
2005 | Year | 02 | Month | 01 | Day |
2005 | Year | 06 | Month | 01 | Day |
2005 | Year | 07 | Month | 01 | Day |
2005 | Year | 09 | Month | 01 | Day |
2006 | Year | 08 | Month | 15 | Day |
2009 | Year | 08 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000572
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