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

Multiple Sclerosis Clinical Trial

— Leptin  

Official title:

The Role of Leptin Levels in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067573
• Other study ID #: USF 6175-A675E9
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: June 14, 2012
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2010
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	USF Health	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	EMD Serono

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting leptin and nitric oxide testing		monthly, for 12 months	No

External Links

•   USF Health Clinical studies