Effect of Low-Dose Baclofen Administration on the GH-IGF1... | NCT00871455

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

NCT00871455

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Apr 2, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Spinal Cord Injury

Interventions

Baclofen

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Mar 27, 2009

First Posted Date

Mar 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2012

Last Update Posted Date

Apr 2, 2012Estimated

Name	Class
Kessler Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.	Drug: Baclofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baclofen	Drug	Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Bauman, MD	VA Medical Center, Bronx	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Medical Center, Bronx		The Bronx	New York	10468	United States

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D010900	Pituitary Diseases

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001418	Baclofen

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided