A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophy
- Conditions
- Spinal and bulbar muscular atrophy (SBMA)MedDRA version: 18.1Level: PTClassification code 10068597Term: Bulbospinal muscular atrophy congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-002608-15-DK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 38
•Genetic diagnosis of SBMA with symptomatic muscle weakness
•Able to complete 2 minute timed walk
•Serum IGF-1 level less than or equal to 170 ng/mL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
• Medically treated diabetes mellitus or known history of hypoglycemia
• History of Bell’s palsy
• Treatment with systemic steroids > 10 mg/day (or equivalent dose); androgens or androgen reducing agents; systemic beta agonists; or other muscle anabolic drugs within the previous 3 months
• History of cancer, other than non-melanomatous skin cancer
• Retinopathy
• Papilledema
Other protocol defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method