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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01067573
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study Start: 2009-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-11
• Study Completion: 2011-07
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting leptin and nitric oxide testing	monthly, for 12 months

Trial Locations

Locations (1)

USF Health; 🇺🇸 Tampa, Florida, United States