Multiple SclerosisLeptinNCT01067573
The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment
An observational study of Multiple Sclerosis, run by University of South Florida at 1 site in United States.
Trial summary
To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple sclerosis patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jul 2011
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: USF Medical Clinic Tampa, Flrida
Who may be able to join
- Confirmed diagnosis of multiple sclerosis per update of McDonald criteria
- Initiating treatment with interferon beta 1a subcutaneous injection with minimal dosing of 22mcg.
- 18-60 years of age.
- Women who are not pregnant or breast feeding, and who do not intend to become pregnant.
- Stable dose of concomitant medications for 30 days prior to baseline. Efforts should be made to maintain steady doses of concomitant medications for the duration of the study.
Who cannot join
- Treatment on other interferon preparations, glatiramer acetate, in last 30 days or 6 months on Natalizumab, mitoxantrone, cyclosporine or other immunomodulators as determined by the PI.
- Treatment with any other investigational treatments within the past year or treatment with any investigational treatments for multiple sclerosis within the last year.
- Any progressive form of MS.
- Known Hypersensitivity to interferon beta 1a.
- Inability to administer subcutaneous injections
- Inability to undergo laboratory evaluation.
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- Seropositivity for HIV (by medical history)
- Diabetes Mellitus Tyle I or II (by medical history)
- Hepatitis B or C (by medical history)
- Uncontrolled psychiatric disorder.
- Any unstable illness that the investigator's opinion precludes participation in this study.
- Inability to maintain compliance with study protocol.
- Implanted devices or metal which would contraindicate MRI.
- Clinically significant abnormalities in CBC or CMP
- MMSE <25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Leptin Levels in Multiple Sclerosis
To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple sclerosis patients.
Read the detailed description
This is an observational pilot study in patients with definitive relapsing-remitting multiple sclerosis to determine whether there is a correlation in serum leptin levels and serum nitric oxide levels during a clinically observed increase in disease activity. Each subject will followed for 12 months while taking interferon beta-1a subcutaneous injections 3 times a week.
- Conditions
- Multiple Sclerosis
- Keywords
- MS, Serum Leptin Levels during relapse, Multiple sclerosis, relapse
- Medical subject headings
- Multiple Sclerosis, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting leptin and nitric oxide testing
Measured: monthly, for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startDec 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Sponsor
- Investigators
- Stanley J Krolczyk, DO, RPH, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067573
- Sponsor's protocol ID
- USF 6175-A675E9
- Acronym
- Leptin
- Status last verified
- Feb 2010
- First submitted
- 10 Feb 2010
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Rosa V, Procaccini C, La Cava A, Chieffi P, Nicoletti GF, Fontana S, Zappacosta S, Matarese G. Leptin neutralization interferes with pathogenic T cell autoreactivity in autoimmune encephalomyelitis. J Clin Invest. 2006 Feb;116(2):447-55. doi: 10.1172/JCI26523. Epub 2006 Jan 12.
PubMed 16410832Musio S, Gallo B, Scabeni S, Lapilla M, Poliani PL, Matarese G, Ohtsu H, Galli SJ, Mantegazza R, Steinman L, Pedotti R. A key regulatory role for histamine in experimental autoimmune encephalomyelitis: disease exacerbation in histidine decarboxylase-deficient mice. J Immunol. 2006 Jan 1;176(1):17-26. doi: 10.4049/jimmunol.176.1.17.
PubMed 16365391
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Leptin Levels in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01067573
- Acronym / sponsor ID
- Leptin / USF 6175-A675E9
- Conditions
- Multiple Sclerosis
- Keywords
- MS, Serum Leptin Levels during relapse, Multiple sclerosis, relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- Dec 2009
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Feb 2010 (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.
To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple sclerosis patients.
Detailed description
This is an observational pilot study in patients with definitive relapsing-remitting multiple sclerosis to determine whether there is a correlation in serum leptin levels and serum nitric oxide levels during a clinically observed increase in disease activity. Each subject will followed for 12 months while taking interferon beta-1a subcutaneous injections 3 times a week.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- USF Medical Clinic Tampa, Flrida
Key inclusion criteria (5 listed)
- Confirmed diagnosis of multiple sclerosis per update of McDonald criteria
- Initiating treatment with interferon beta 1a subcutaneous injection with minimal dosing of 22mcg.
- 18-60 years of age.
- Women who are not pregnant or breast feeding, and who do not intend to become pregnant.
- Stable dose of concomitant medications for 30 days prior to baseline. Efforts should be made to maintain steady doses of concomitant medications for the duration of the study.
Key exclusion criteria (15 listed)
- Treatment on other interferon preparations, glatiramer acetate, in last 30 days or 6 months on Natalizumab, mitoxantrone, cyclosporine or other immunomodulators as determined by the PI.
- Treatment with any other investigational treatments within the past year or treatment with any investigational treatments for multiple sclerosis within the last year.
- Any progressive form of MS.
- Known Hypersensitivity to interferon beta 1a.
- Inability to administer subcutaneous injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fasting leptin and nitric oxide testing
Time frame: monthly, for 12 months
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 18 Jun 2012.
- Background: PubMed 16410832De Rosa V, Procaccini C, La Cava A, Chieffi P, Nicoletti GF, Fontana S, Zappacosta S, Matarese G. Leptin neutralization interferes with pathogenic T cell autoreactivity in autoimmune encephalomyelitis. J Clin Invest. 2006 Feb;116(2):447-55. doi: 10.1172/JCI26523. Epub 2006 Jan 12.
- Background: PubMed 16365391Musio S, Gallo B, Scabeni S, Lapilla M, Poliani PL, Matarese G, Ohtsu H, Galli SJ, Mantegazza R, Steinman L, Pedotti R. A key regulatory role for histamine in experimental autoimmune encephalomyelitis: disease exacerbation in histidine decarboxylase-deficient mice. J Immunol. 2006 Jan 1;176(1):17-26. doi: 10.4049/jimmunol.176.1.17.
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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.
Stanley J Krolczyk, DO, RPH principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of South Florida 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 5 inclusion and 15 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 18 Jun 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?
Fasting leptin and nitric oxide testing (time frame: monthly, for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067573, which also lists 2 linked publications.
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 18 Jun 2012.