Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Phase 2
- Conditions
- Spinal and bulbar muscular atrophy (SBMA)
- Registration Number
- JPRN-UMIN000000474
- Lead Sponsor
- Department of Neurology, Nagoya University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Motor function(ALSFRS-R)
- Secondary Outcome Measures
Name Time Method Frequency of aspiration pneumonia, serum creatine kinase, serum testosterone, liver function test, HbA1c, NCV, immunohistological study of scrotal skin biopsy and Respiratory function test.