Clinical Trial: Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body
Brief Summary: This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Effect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ]
Original Primary Outcome: Measure: To assess the affect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ]
Current Secondary Outcome: Effect of BYM338 on muscle function by 'Timed Get Up and Go' test [ Time Frame: 8 weeks ]
Original Secondary Outcome: Measure: To assess the effect of BYM338 on muscle function by 'Timed Get Up and Go' test [ Time Frame: 8 weeks ]
Information By: Novartis
Dates:
Date Received: August 12, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017