NCT02024932

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

A Two-part Placebo-controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy (SBMA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Spinal and Bulbar Muscular Atrophy

Interventions

Type	Name	Description
DRUG	BVS857	BVS857 lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..
DRUG	Placebo	Placebo lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..

Timeline

• Start date: 2014-02-04
• Primary completion: 2016-04-13
• Completion: 2016-04-13
• First posted: 2013-12-31
• Last updated: 2021-01-05
• Results posted: 2017-08-11

Locations

6 sites across 4 countries: United States, Denmark, Germany, Italy