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Completed

NCT Number: NCT00871455

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

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.

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Key information

Conditions

Spinal Cord Injury Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Nervous System Diseases Pituitary Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baclofen

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • Kessler Foundation

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2011
First posted
Mar 30, 2009
Registry last updated
Apr 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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