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

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT00871455

Run by

US Department of Veterans Affairs

People needed

20

Starts

2003-04-01

Expected to finish

2011-12-01

Last updated by the study team

2012-04-02

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with chronic SCI (injury greater than 6 months) who have been screened and found to have depressed plasma IGF-1 levels and who are not taking baclofen.

You may not qualify if…

• Acute illness of any etiology,
• Patients with chronic renal, liver, lung, or cardiac disease,
• Patients receiving any of the following medications: narcotics, or L-DOPA, and
• Alcoholics.

Where it is running

• VA Medical Center, Bronx — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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