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)

Phase 1/2 Completed 17 enrolled University of Rochester Imsmed Incorporated · collab National Institute of Neurological Disorders and Stroke (NINDS) · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-11
Primary completion: 2008-05
Completion: 2008-05

Publications

Heatwole CR, Eichinger KJ, Friedman DI, Hilbert JE, Jackson CE, Logigian EL, Martens WB, McDermott MP, Pandya SK, Quinn C, Smirnow AM, Thornton CA, Moxley RT 3rd. Open-label trial of recombinant human insulin-like growth factor 1/recombinant human insulin-like growth factor binding protein 3 in myotonic dystrophy type 1. Arch Neurol. 2011 Jan;68(1):37-44. doi: 10.1001/archneurol.2010.227. Epub 2010 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rhIGF-1/rhIGFBP-3	Protein / enzyme biologic	1 mg/kg	Subcutaneous
Subject	rhIGF-1/rhIGFBP-3	Protein / enzyme biologic	2 mg/kg	Subcutaneous

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)

Summary

Timeline

Publications

Drugs

Indications