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

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00871455

Collaborator

Kessler Foundation (Other)

Enrollment

Location

Arm

104

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Drug: Baclofen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.	Drug: Baclofen Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.

Arm

Intervention/Treatment

Experimental: 1

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

Drug: Baclofen

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.