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

NCT00871455 | Completed

• 1 other identifier: B4162C-7
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

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

  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

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

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Baclofen

Interventions

Baclofen DRUG

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

1

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Kessler Foundation: collaborator

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pituitary Diseases

Interventions

Baclofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• William Bauman, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2011
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

US (1)