Clinical Trial: Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of SomatoKine (Iplex) (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
Brief Summary: The aim of this study is to investigate the safety and feasibility of daily subcutaneous injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED) as a treatment for muscle wasting and weakness in myotonic dystrophy type 1.
Detailed Summary:
Sponsor: University of Rochester
Current Primary Outcome: The Number of Study Participants Who Safely Tolerated Somatokine [ Time Frame: 24 weeks ]
Original Primary Outcome: Safety and tolerability of SomatoKine during this study is the primary outcome measure in patients with DM-1.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Rochester
Dates:
Date Received: October 3, 2005
Date Started: November 2005
Date Completion:
Last Updated: June 20, 2012
Last Verified: June 2012