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

This study has been completed.
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00871455
First received: March 26, 2009
Last updated: March 29, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Department of Veterans Affairs:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871455

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00871455     History of Changes
Other Study ID Numbers: B4162C-7
Study First Received: March 26, 2009
Last Updated: March 29, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Spinal Cord Injury
Baclofen
Growth Hormone, Pituitary
Insulin-Like Growth Factor I

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014