Phase 3
Completed N=50
Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
Source: ClinicalTrials.gov NCT02939079 ↗Enrolled (actual)
50
Serious AEs
8.0%
Results posted
May 2019
Primary outcomePrimary: Serum Level of TNF-α — 37.16; 28.79 Pg/ml
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in patients with Relapsing-Remitting Multiple Sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Level of TNF-α |
21.20; 16.47 | — |
| PRIMARY Serum Level of IL1b |
13.17; 13.15 | — |
| PRIMARY Serum Level of IL6 |
6.17; 6.05 | — |
| PRIMARY Serum Level of IFN-gamma |
5.92; 5.99 | — |
| PRIMARY Serum Level of TNF-α |
21.20; 16.47 | — |
| PRIMARY Serum Level of TNF-α |
21.20; 16.47 | — |
| PRIMARY Serum Level of IL1b |
13.17; 13.15 | — |
| PRIMARY Serum Level of IL1b |
13.17; 13.15 | — |
| PRIMARY Serum Level of IL6 |
6.17; 6.05 | — |
| PRIMARY Serum Level of IL6 |
6.17; 6.05 | — |
| PRIMARY Serum Level of IFN-gamma |
5.92; 5.99 | — |
| PRIMARY Serum Level of IFN-gamma |
5.92; 5.99 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02939079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.