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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes