NCT00233519

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)

Effects of SomatoKine (Iplex) (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myotonic Dystrophy

Interventions

Type	Name	Description
DRUG	SomatoKine/IPLEX	Cohort 1: self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks. Cohort 2: consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2005-10-05
• Last updated: 2012-06-25
• Results posted: 2010-02-01

Locations

1 site across 1 country: United States