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Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT02939079
Recruitment Status : Completed
First Posted : October 19, 2016
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Vahid Shaygannejad, Isfahan University of Medical Sciences

Brief Summary:
This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in patients with Relapsing-Remitting Multiple Sclerosis.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Fingolimod Dietary Supplement: Fish Oil Drug: Placebo (for Fish Oil) Phase 2 Phase 3

Detailed Description:

Multiple Sclerosis (MS) is a chronic autoimmune disease characterized by inflammatory demyelinative lesions in central nervous system. Relapsing-Remitting MS is the most common form of the disease observed in 85% of patients. This form presents with acute or sub-acute onset of neurological symptoms and patients may fully or partially recover and relapses may occur from time to time.

Regarding MS pathogenesis, the findings suggest the role of environmental factors in triggering the innate immune system and activating T cells and the onset of a chronic inflammatory response against myelin antigens in the central nervous system in people who are genetically prone to the disease. Among immune cells, T helper 17 (Th17) plays an important role in autoimmune response and are shown to be involved in clinical course of Relapsing-Remitting MS. Th17 cell differentiation is controlled by several cytokines, including interleukin-6 (IL-6), interleukin-1b (IL-1b) and interleukin-10 (IL-10). Also, IL 6 have an inhibitory effect on Th17 cell differentiation through increased production of interferon-gamma (IFN-gamma) and IL 10.

Currently, immunomodulatory drugs are considered as the first line treatment in MS. Fingolimod is the first oral immunomodulatory medication used for Relapsing-Remitting MS. It is phosphorylated by crossing the blood-brain barrier and is converted to its active metabolite, Fingolimod-P. This metabolite acts as a Sphingosine-1-phosphate receptor (S1PR1) on oligodendrocytes, microglias, astrocytes, and neurons and inhibits the entry of lymphocytes into the central nervous system. Therefore, it reduces demyelination and may also lead to remyelination.

Nutrition is known as a possible environmental factor in pathogenesis of MS. Positive clinical and biological effects of dietary supplements containing polyunsaturated fatty acids omega -3 (PUFA) in the course of autoimmune diseases such as MS have been studied. High levels of PUFA is found in fish oil which is also known as an antioxidant, anti-inflammatory and immunomodulatory agent. Several studies have evaluated the effect of fish oil as a dietary supplement in the treatment of MS however, conflicting findings are reported.

In this study, the investigators aim to evaluate the effect of Fingolimod with Fish oil compared to Fingolimod with placebo on TNF-α, IL1b, IL6, and IFN-gamma in patients with Relapsing-Remitting Multiple sclerosis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-α , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple Sclerosis
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fingolimod and Fish Oil
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Drug: Fingolimod
Produced by Osveh ® Pharm Company in Iran
Other Name: Fingolid ®

Dietary Supplement: Fish Oil
produced by Zahravi ® Pharm Company in Iran
Other Names:
  • CODLIVE ®
  • OMEGAMAX ®

Active Comparator: Fingolimod and Placebo
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Drug: Fingolimod
Produced by Osveh ® Pharm Company in Iran
Other Name: Fingolid ®

Drug: Placebo (for Fish Oil)
placebo capsules to mimic Fish Oil 1 g capsules




Primary Outcome Measures :
  1. Serum Level of TNF-α [ Time Frame: Baseline ]
    5 cc of venous blood is taken from patients and are kept in test tubes without ethylenediaminetetraacetic acid (EDTA). Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  2. Serum Level of IL1b [ Time Frame: Baseline ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  3. Serum Level of IL6 [ Time Frame: Baseline ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  4. Serum Level of IFN-gamma [ Time Frame: Baseline ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  5. Serum Level of TNF-α [ Time Frame: 6 months after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  6. Serum Level of TNF-α [ Time Frame: 1 year after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  7. Serum Level of IL1b [ Time Frame: 6 months after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  8. Serum Level of IL1b [ Time Frame: 1 year after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  9. Serum Level of IL6 [ Time Frame: 6 months after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  10. Serum Level of IL6 [ Time Frame: 1 year after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  11. Serum Level of IFN-gamma [ Time Frame: 6 months after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.

  12. Serum Level of IFN-gamma [ Time Frame: 1 year after intervention ]
    5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with relapsing-remitting multiple sclerosis according to McDonald's criteria (2010)
  • Age between 18 and 45 years
  • Expanded Disability Status Scale (EDSS) between 0-5
  • History of at least one relapse during the last year
  • Intolerance or serious complications when receiving interferons
  • Not receiving interferons in the last two months
  • Not having relapse in the last 30 days
  • Negative pregnancy test
  • History of varicella or varicella vaccination, or positive test for anti-varicella antibodies
  • Not to take any medication or dietary complement without permission of the physician
  • Filling informed consent

Exclusion Criteria:

  • Having chronic and infectious diseases
  • History of cardiovascular diseases
  • Taking corticosteroids in the last 30 days
  • Taking chemotherapy agents such as Cyclophosphamide
  • Patients who have taken fingolimod before
  • Patients who experience relapse during the study

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 ClinicalTrials.gov identifier (NCT number): NCT02939079


Sponsors and Collaborators
Isfahan University of Medical Sciences
Shiraz University of Medical Sciences
Investigators
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Study Chair: Shaygannejad Shaygannejad, M.D. Isfahan University of Medical Sciences

Publications:

Layout table for additonal information
Responsible Party: Vahid Shaygannejad, Associate Professor of Neurology, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02939079     History of Changes
Other Study ID Numbers: 293396
First Posted: October 19, 2016    Key Record Dates
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators may make individual participant data available regarding drug side effects or other factors that need to be described individually however the primary outcome will be published as group result and not individual results.

Keywords provided by Vahid Shaygannejad, Isfahan University of Medical Sciences:
Multiple Sclerosis
Fingolimod
Fish Oil

Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs