Spinal Cord InjuryNCT00871455
Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study
A study testing Baclofen in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Baclofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Baclofen
- Keywords
- Spinal Cord Injury, Baclofen, Growth Hormone, Pituitary, Insulin-Like Growth Factor I
- Medical subject headings
- Spinal Cord Injuries, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks. Receives: Drug: Baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2003
- Primary completionDec 2007
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Kessler Foundation
- Responsible party
- Sponsor
- Investigators
- William Bauman, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871455
- Sponsor's protocol ID
- B4162C-7
- Status last verified
- Mar 2012
- First submitted
- 26 Mar 2009
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study
- ClinicalTrials.gov ID
- NCT00871455
- Acronym / sponsor ID
- B4162C-7
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Baclofen, Growth Hormone, Pituitary, Insulin-Like Growth Factor I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Kessler Foundation
- Study start
- Apr 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BaclofenSubjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaclofenSubjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks. | Drug | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Bauman, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baclofen in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.