Clinical trial NCT01067573: The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment
Official title: The Role of Leptin Levels in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: MS
Serum Leptin Levels during relapse
Multiple sclerosis
relapse
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: EMD Serono
First posted: 2010-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: USF Medical Clinic Tampa, Flrida

Brief 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.

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.

Eligibility criteria: 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 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.

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 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

Primary outcomes:
measure: Fasting leptin and nitric oxide testing
timeFrame: monthly, for 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health
state: Florida
Study officials:
affiliation: University of South Florida
name: Stanley J Krolczyk, DO, RPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.4049/jimmunol.176.1.17.