The Role of Serum Leptin Levels in Multiple Sclerosis Dis... | NCT01067573

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

NCT01067573

Sponsor

University of South Florida

Status

Completed

Last Update Posted

Jun 18, 2012Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Not provided

Completion Date

Jul 2011Actual

First Submitted Date

Feb 10, 2010

First Submission Date that Met QC Criteria

Feb 10, 2010

First Posted Date

Feb 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2012

Last Update Posted Date

Jun 18, 2012Estimated

Name	Class
EMD Serono	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

USF Medical Clinic Tampa, Flrida

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Stanley J Krolczyk, DO, RPH	University of South Florida	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
USF Health		Tampa	Florida	33612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16410832	Background	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.
16365391	Background	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.

ID	Term
D009103	Multiple Sclerosis
D012008	Recurrence

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases