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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871455
• Other study ID #: B4162C-7
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: March 29, 2012
• Start date: April 2003
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Baclofen
Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No