Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy

• Status: Completed
• Trial end date: 2016-04-13
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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