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

This study has been completed.
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01067573
First received: February 10, 2010
Last updated: June 14, 2012
Last verified: February 2010
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Role of Leptin Levels in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Fasting leptin and nitric oxide testing [ Time Frame: monthly, for 12 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2009
Study Completion Date: July 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

USF Medical Clinic Tampa, Flrida

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067573

Locations
United States, Florida
USF Health
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
EMD Serono
Investigators
Principal Investigator: Stanley J Krolczyk, DO, RPH University of South Florida
  More Information

Publications:
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01067573     History of Changes
Other Study ID Numbers: USF 6175-A675E9
Study First Received: February 10, 2010
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
MS
Serum Leptin Levels during relapse
Multiple sclerosis
relapse

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014