Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remi
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Fish oil
Supplement
Placebo
- Placebo (for Fish Oil)
Given to everyone in the trial
Results by group
Serum Level of TNF-α
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 37.16 Pg/ml | 92.74 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 28.79 Pg/ml | 47.46 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IL1b
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 13.76 Pg/ml | 0.74 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 14 Pg/ml | 1.03 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IL6
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 6.19 Pg/ml | 0.35 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 6.33 Pg/ml | 0.58 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IFN-gamma
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 6.38 Pg/ml | 1.51 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 6.98 Pg/ml | 3.87 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of TNF-α
6 months after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 28.03 Pg/ml | 60.36 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 17.18 Pg/ml | 18.88 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of TNF-α
1 year after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 21.20 Pg/ml | 36.45 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 16.47 Pg/ml | 16.64 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IL1b
6 months after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 13.61 Pg/ml | 0.58 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 13.47 Pg/ml | 0.74 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IL1b
1 year after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 13.17 Pg/ml | 0.52 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 13.15 Pg/ml | 0.61 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IL6
6 months after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 6.65 Pg/ml | 2.11 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 6.17 Pg/ml | 0.71 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IL6
1 year after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 6.17 Pg/ml | 0.76 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 6.05 Pg/ml | 0.47 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IFN-gamma
6 months after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 5.71 Pg/ml | 0.57 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 6.37 Pg/ml | 1.77 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Serum Level of IFN-gamma
1 year after intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod and Fish Oil | 5.92 Pg/ml | 1.31 (Standard Deviation) | 21 |
| Fingolimod and Placebo | 5.99 Pg/ml | 0.84 (Standard Deviation) | 20 |
Fingolimod and Fish Oil
Fingolimod and Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod and Fish Oil | 25 | 2 (8.0%) | 0 |
| Fingolimod and Placebo | 25 | 2 (8.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Serum Level of TNF-α
Baseline
Serum Level of IL1b
Baseline
Immune responseSerum Level of IL6
Baseline
Immune responseSerum Level of IFN-gamma
Baseline
Serum Level of TNF-α
6 months after intervention
Serum Level of TNF-α
1 year after intervention
Serum Level of IL1b
6 months after intervention
Immune responseSerum Level of IL1b
1 year after intervention
Immune responseSerum Level of IL6
6 months after intervention
Immune responseSerum Level of IL6
1 year after intervention
Immune responseSerum Level of IFN-gamma
6 months after intervention
Serum Level of IFN-gamma
1 year after intervention
Who could take part
Relapsing MS · 18 to 45 · EDSS 0 to 5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in patients with Relapsing-Remitting Multiple Sclerosis.
Papers
Background
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.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.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.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.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.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.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.
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History
Started
Apr 2015
Main results due
Sept 2016
Finished
Oct 2016
Results posted
May 2019