We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871455
First Posted: March 30, 2009
Last Update Posted: April 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Spinal Cord Injury Drug: Baclofen

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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

Enrollment: 20
Study Start Date: April 2003
Study Completion Date: December 2011
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871455


Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Kessler Foundation
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00871455     History of Changes
Other Study ID Numbers: B4162C-7
First Submitted: March 26, 2009
First Posted: March 30, 2009
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by VA Office of Research and Development:
Spinal Cord Injury
Baclofen
Growth Hormone, Pituitary
Insulin-Like Growth Factor I

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries