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

The Role of Leptin Levels in Multiple Sclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01067573

Acronym

Leptin

Enrollment

Registered

2010-02-11

Start date

2009-12-31

Completion date

2011-07-31

Last updated

2012-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

MS, Serum Leptin Levels during relapse, Multiple sclerosis, relapse

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Fasting leptin and nitric oxide testing	monthly, for 12 months

Countries

United States

Outcome results