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

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Drug: Baclofen

• Registration Number: NCT00871455
• Lead Sponsor: US Department of Veterans Affairs

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2007-12
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-29
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Baclofen	Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Determine the threshold dose 20 or 40 mg/d of baclofen and the dose-response curve of the medication for its effect to raise plasma IGF-1 levels	20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy

Secondary Outcome Measures

Name	Time	Method
Assessment of the adverse side effects, if any, of low dose baclofen therapy	20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy

Trial Locations

Locations (1)

VA Medical Center, Bronx; 🇺🇸 Bronx, New York, United States