At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
BVS857 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating BVS857 and Placebo for Spinal and Bulbar Muscular Atrophy. Completed, enrolled 37 participants across 6 sites in 4 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal and Bulbar Muscular Atrophy
CountriesDenmark, Germany, Italy, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartFeb 2014
Primary CompletionApr 2016
TodayJul 2026
First PostedDec 31, 2013
Enrollment StartFeb 4, 2014
Primary CompletionApr 13, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.5 years ago
Interventions
BVS857drug
BVS857 lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..
Placebodrug
Placebo lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..