NCT00871455

Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Insulin-like growth factor I (IGF-I) is used as a measure of the body's ability to produce growth hormone. Growth hormone is important for muscle tissue as well as many other tissues in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I levels. IGF-I levels will be determined before and after treatment with baclofen. In this study, the investigators will determine the minimum dose of baclofen at which improvements in GH and IGF-1 levels occur.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Baclofen	Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.

Timeline

• Start date: 2003-04-01
• Primary completion: 2007-12-01
• Completion: 2011-12-01
• First posted: 2009-03-30
• Last updated: 2012-04-02

Locations

1 site across 1 country: United States