COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067573
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : June 18, 2012
EMD Serono
Information provided by (Responsible Party):
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.

Condition or disease
Multiple Sclerosis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Role of Leptin Levels in Multiple Sclerosis
Study Start Date : December 2009
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Fasting leptin and nitric oxide testing [ Time Frame: monthly, for 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
USF Medical Clinic Tampa, Flrida

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067573

Layout table for location information
United States, Florida
USF Health
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
EMD Serono
Layout table for investigator information
Principal Investigator: Stanley J Krolczyk, DO, RPH University of South Florida
Additional Information:
Layout table for additonal information
Responsible Party: University of South Florida Identifier: NCT01067573    
Other Study ID Numbers: USF 6175-A675E9
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: February 2010
Keywords provided by University of South Florida:
Serum Leptin Levels during relapse
Multiple sclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases