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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01067573

Run by

University of South Florida

People needed

20

Starts

2009-12-01

Expected to finish

2011-07-01

Last updated by the study team

2012-06-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• USF Health — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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