Trial | NCT00871455  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    baclofen ...

  • Study Participants

    20
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.
Study Started
Apr 30
2003
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2011
Last Update
Apr 02
2012
Estimate

Drug Baclofen

Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.

1 Experimental

Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.

Criteria 

Inclusion Criteria:

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.

Exclusion Criteria:

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.
No Results Posted