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The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment

Information source: University of South Florida
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Phase: N/A

Status: Completed

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Stanley J Krolczyk, DO, RPH, Principal Investigator, Affiliation: University of South Florida


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.

Clinical Details

Official title: The Role of Leptin Levels in Multiple Sclerosis

Study design: Observational Model: Case-Crossover, Time Perspective: Prospective

Primary outcome: Fasting leptin and nitric oxide testing

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- 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


- 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. Exclusion Criteria:

- 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.

- 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


- Inability to maintain compliance with study protocol.

- Implanted devices or metal which would contraindicate MRI.

- Clinically significant abnormalities in CBC or CMP

- MMSE <25

Locations and Contacts

USF Health, Tampa, Florida 33612, United States
Additional Information

Related 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. Epub 2006 Jan 12.

Musio 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.

Starting date: December 2009
Last updated: June 14, 2012

Page last updated: August 20, 2015

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