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

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Baclofen

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Baclofen, Growth Hormone, Pituitary, Insulin-Like Growth Factor I

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

VA Medical Center, Bronx

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

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

Secondary Outcome Measures

Assessment of the adverse side effects, if any, of low dose baclofen therapy

Full Information

NCT ID

NCT00871455

First Posted

March 26, 2009

Last Updated

March 29, 2012

Sponsor

US Department of Veterans Affairs

Collaborators

Kessler Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00871455

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

US Department of Veterans Affairs

Collaborators

Kessler Foundation

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Baclofen

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy

Secondary Outcome Measure Information:

Title

Assessment of the adverse side effects, if any, of low dose baclofen therapy

Time Frame

20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Bauman, MD

Organizational Affiliation

VA Medical Center, Bronx

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Medical Center, Bronx

City

Bronx

State/Province

New York

ZIP/Postal Code

10468

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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