NCT01067573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 18, 2012

Status Verified

February 1, 2010

First QC Date

February 10, 2010

Last Update Submit

June 14, 2012

Conditions

Multiple Sclerosis

Keywords

MSSerum Leptin Levels during relapseMultiple sclerosisrelapse

Outcome Measures

Primary Outcomes (1)

  • Fasting leptin and nitric oxide testing

    monthly, for 12 months

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

USF Medical Clinic Tampa, Flrida

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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USF Health

Tampa, Florida, 33612, United States

Location

Related Publications (2)

  • De Rosa V, Procaccini C, La Cava A, Chieffi P, Nicoletti GF, Fontana S, Zappacosta S, Matarese G. Leptin neutralization interferes with pathogenic T cell autoreactivity in autoimmune encephalomyelitis. J Clin Invest. 2006 Feb;116(2):447-55. doi: 10.1172/JCI26523. Epub 2006 Jan 12.

    PMID: 16410832BACKGROUND

  • Musio S, Gallo B, Scabeni S, Lapilla M, Poliani PL, Matarese G, Ohtsu H, Galli SJ, Mantegazza R, Steinman L, Pedotti R. A key regulatory role for histamine in experimental autoimmune encephalomyelitis: disease exacerbation in histidine decarboxylase-deficient mice. J Immunol. 2006 Jan 1;176(1):17-26. doi: 10.4049/jimmunol.176.1.17.

    PMID: 16365391BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisRecurrence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stanley J Krolczyk, DO, RPH

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 11, 2010

Study Start

December 1, 2009

Study Completion

July 1, 2011

Last Updated

June 18, 2012

Record last verified: 2010-02

Locations

US(1)