NCT01207908

Safety and Efficacy Study of IGF-1 in Duchenne Muscular Dystrophy

IGF-1 Therapy and Muscle Function in Duchenne Muscular Dystrophy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: Male
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether IGF-1 therapy improves or preserves muscle function in Duchenne Muscular Dystrophy (DMD).

Detailed description

Detailed Description: DMD is a progressive degenerative muscle disorder for which there is no current cure. Glucocorticoids (GC) are often used to improve motor function and survival but have significant side effects such as growth failure, weight gain, insulin resistance and osteoporosis. IGF-1 stimulates both the proliferation and differentiation of skeletal muscle cells and is thus important for muscle repair and regeneration. IGF-1 offers potential as a therapeutic agent for DMD as it may improve or preserve motor function and reduce GC side effects such as growth failure and insulin resistance.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	IGF-1	IGF-1 will be administered once daily by subcutaneous injection every morning with breakfast. Duration 6 months.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-10-01
• Completion: 2013-06-01
• First posted: 2010-09-23
• Last updated: 2021-01-20
• Results posted: 2021-01-20

Locations

1 site across 1 country: United States