UMIN ID: UMIN000000474
Registered date:01/09/2006
Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Spinal and bulbar muscular atrophy (SBMA) |
| Date of first enrollment | 2003/09/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Leuprorelin acetate 3.75 mg subcutaneous injection every 4 weeks Placebo subcutaneous injection every 4 weeks |
Outcome(s)
| Primary Outcome | Motor function(ALSFRS-R) |
|---|---|
| Secondary Outcome | Frequency of aspiration pneumonia, serum creatine kinase, serum testosterone, liver function test, HbA1c, NCV, immunohistological study of scrotal skin biopsy and Respiratory function test. |
Key inclusion & exclusion criteria
| Age minimum | 30years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Department of Neurology, Nagoya University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant-in-Aid for Scientific Research |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 65 Tsurumai, Showa-ku, Nagoya, Aichi Japan |
| Telephone | 052-744-2390 |
| sbma@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University, School of Medicine Department of Neurology |
| scientific contact | |
| Name | Gen Sobue |
| Address | 65 Tsurumai, Showa-ku, Nagoya, Aichi Japan |
| Telephone | 052-744-2385 |
| Affiliation | Nagoya University, School of Medicine Department of Neurology |