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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871455

Enrollment

Registered

2009-03-30

Start date

2003-04-30

Completion date

2011-12-31

Last updated

2012-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury, Baclofen, Growth Hormone, Pituitary, Insulin-Like Growth Factor I

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.

Interventions

DRUGBaclofen

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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.

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026