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

NCT02939079 | Completed Phase 2 Results

• 1 other identifier: 293396
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Fingolimod; Fish Oil

Outcome Measures

Primary Outcomes (12)

• Serum Level of TNF-α

  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.

  Baseline

• Serum Level of IL1b

  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.

  Baseline

• Serum Level of IL6

  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.

  Baseline

• Serum Level of IFN-gamma

  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.

  Baseline

• Serum Level of TNF-α

  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 months after intervention

• Serum Level of TNF-α

  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.

  1 year after intervention

• Serum Level of IL1b

  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 months after intervention

• Serum Level of IL1b

  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.

  1 year after intervention

• Serum Level of IL6

  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 months after intervention

• Serum Level of IL6

  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.

  1 year after intervention

• Serum Level of IFN-gamma

  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 months after intervention

• Serum Level of IFN-gamma

  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.

  1 year after intervention

Study Arms (2)

Fingolimod and Fish Oil

EXPERIMENTAL

Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.

Drug: Fingolimod; Dietary Supplement: Fish Oil

Fingolimod and Placebo

ACTIVE COMPARATOR

Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.

Drug: Fingolimod; Drug: Placebo (for Fish Oil)

Interventions

Fingolimod DRUG

Produced by Osveh ® Pharm Company in Iran

Also known as: Fingolid ®

Fingolimod and Fish Oil; Fingolimod and Placebo

Fish Oil DIETARY_SUPPLEMENT

produced by Zahravi ® Pharm Company in Iran

Also known as: CODLIVE ®, OMEGAMAX ®

Fingolimod and Fish Oil

Placebo (for Fish Oil) DRUG

placebo capsules to mimic Fish Oil 1 g capsules

Fingolimod and Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead
• Shiraz University of Medical Sciences: collaborator

Related Publications (7)

• Aktas O, Kury P, Kieseier B, Hartung HP. Fingolimod is a potential novel therapy for multiple sclerosis. Nat Rev Neurol. 2010 Jul;6(7):373-82. doi: 10.1038/nrneurol.2010.76. Epub 2010 Jun 15.

  PMID: 20551946 BACKGROUND

• Brinkmann V, Billich A, Baumruker T, Heining P, Schmouder R, Francis G, Aradhye S, Burtin P. Fingolimod (FTY720): discovery and development of an oral drug to treat multiple sclerosis. Nat Rev Drug Discov. 2010 Nov;9(11):883-97. doi: 10.1038/nrd3248. Epub 2010 Oct 29.

  PMID: 21031003 BACKGROUND

• Gallai V, Sarchielli P, Trequattrini A, Franceschini M, Floridi A, Firenze C, Alberti A, Di Benedetto D, Stragliotto E. Cytokine secretion and eicosanoid production in the peripheral blood mononuclear cells of MS patients undergoing dietary supplementation with n-3 polyunsaturated fatty acids. J Neuroimmunol. 1995 Feb;56(2):143-53. doi: 10.1016/0165-5728(94)00140-j.

  PMID: 7860710 BACKGROUND

• Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):387-401. doi: 10.1056/NEJMoa0909494. Epub 2010 Jan 20.

  PMID: 20089952 BACKGROUND

• Nordvik I, Myhr KM, Nyland H, Bjerve KS. Effect of dietary advice and n-3 supplementation in newly diagnosed MS patients. Acta Neurol Scand. 2000 Sep;102(3):143-9. doi: 10.1034/j.1600-0404.2000.102003143.x.

  PMID: 10987373 BACKGROUND

• Ramirez-Ramirez V, Macias-Islas MA, Ortiz GG, Pacheco-Moises F, Torres-Sanchez ED, Sorto-Gomez TE, Cruz-Ramos JA, Orozco-Avina G, Celis de la Rosa AJ. Efficacy of fish oil on serum of TNF alpha , IL-1 beta , and IL-6 oxidative stress markers in multiple sclerosis treated with interferon beta-1b. Oxid Med Cell Longev. 2013;2013:709493. doi: 10.1155/2013/709493. Epub 2013 Jun 18.

  PMID: 23861993 BACKGROUND

• Torkildsen O, Wergeland S, Bakke S, Beiske AG, Bjerve KS, Hovdal H, Midgard R, Lilleas F, Pedersen T, Bjornara B, Dalene F, Kleveland G, Schepel J, Olsen IC, Myhr KM. omega-3 fatty acid treatment in multiple sclerosis (OFAMS Study): a randomized, double-blind, placebo-controlled trial. Arch Neurol. 2012 Aug;69(8):1044-51. doi: 10.1001/archneurol.2012.283.

  PMID: 22507886 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride; Fish Oils

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines; Oils; Lipids

Limitations and Caveats

Small sample size and trial duration; Not giving patients specific nutritional diets; Receiving tocopherol in the placebo capsules which may confound our findings considering the antioxidant nature of tocopherol; Lower doses of fish oil prescribed.

Results Point of Contact

• Title: Dr. Vahid Shaygannejad
• Organization: Isfahan University of Medical Sciences

shaygannejad@med.mui.ac.ir

+98 913 313 3550

Study Officials

• Shaygannejad Shaygannejad, M.D.

  Isfahan University of Medical Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 19, 2016
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 14, 2019
• Results First Posted: May 14, 2019

Record last verified: 2019-04