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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-UMIN000000474 |
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Date of registration:
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01/09/2006 |
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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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Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
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Scientific title:
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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 |
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Date of first enrolment:
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2003/09/01 |
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Target sample size:
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40 |
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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=R000000572 |
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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 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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Address:
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65 Tsurumai, Showa-ku, Nagoya, Aichi
Japan |
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Telephone:
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052-744-2390 |
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Email:
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sbma@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya University, School of Medicine Department of Neurology |
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Name:
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Gen Sobue |
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Address:
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65 Tsurumai, Showa-ku, Nagoya, Aichi
Japan |
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Telephone:
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052-744-2385 |
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Email:
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Affiliation:
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Nagoya University, School of Medicine Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 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.
Age minimum:
30years-old
Age maximum:
70years-old
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Spinal and bulbar muscular atrophy (SBMA)
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Intervention(s)
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Leuprorelin acetate 3.75 mg subcutaneous injection every 4 weeks
Placebo subcutaneous injection every 4 weeks
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Primary Outcome(s)
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Motor function(ALSFRS-R)
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Secondary Outcome(s)
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Frequency of aspiration pneumonia, serum creatine kinase, serum testosterone, liver function test, HbA1c, NCV, immunohistological study of scrotal skin biopsy and Respiratory function test.
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Source(s) of Monetary Support
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Grant-in-Aid for Scientific Research
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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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01/02/2005 |
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URL:
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