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

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Drug: Baclofen

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00871455

B4162C-7

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: Baclofen