Clinical trial · Interventional
Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
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
NCT02939079CI-TRIAL-00038604completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in patients with Relapsing-Remitting Multiple Sclerosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Sclerosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fingolimod | Drug | — | UNRESOLVED |
| Fish Oil | Dietary Supplement | — | UNRESOLVED |
| Placebo (for Fish Oil) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fingolimod and Fish Oil
- description
- Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
- interventionNames
- Drug: Fingolimod
- Dietary Supplement: Fish Oil
- type
- ACTIVE_COMPARATOR
- label
- Fingolimod and Placebo
- description
- Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
- interventionNames
- Drug: Fingolimod
- Drug: Placebo (for Fish Oil)
Primary outcomes (12)
- measure
- Serum Level of TNF-α
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDAktas 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
- BACKGROUNDBrinkmann 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
- BACKGROUNDGallai 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
- BACKGROUNDKappos 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
- BACKGROUNDNordvik 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
- BACKGROUNDRamirez-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