NCT00533221

Pilot Study of Growth Hormon to Treat SMA Typ II and III

Can Treatment With Human Growth Hormone Increase Strength in Spinal Muscular Atrophy Type II and III?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 6 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Growth hormon can increase strength in spinal muscular atrophy type II and III.

Detailed description

This pilot study is planned as a placebo-controlled cross-over trial in a limited number of patients. It is the aim to investigate the effect of GH on the short-term changes of strength and to investigate the tolerability of the treatment. If the results of the study are positive, further studies of longer duration addressing the development of motor function and quality of life could follow

Conditions

• Muscular Atrophy, Spinal

Interventions

Type	Name	Description
DRUG	somatotropin	0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
DRUG	Placebo	0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-02-01
• Completion: 2011-08-01
• First posted: 2007-09-21
• Last updated: 2013-12-18

Locations

6 sites across 1 country: Germany