The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment
This study has been completed.
Sponsor:
University of South Florida
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
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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 |
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
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
Additional 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 Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Interferon beta 1a Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013