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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02939079
• Date of registration: 14/10/2016
• Prospective Registration: No
• Primary sponsor: Isfahan University of Medical Sciences
• Public title: Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
• Scientific title: Evaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple Sclerosis
• Date of first enrolment: April 2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02939079
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Contacts

• Name: Shaygannejad Shaygannejad, M.D.
• Affiliation: Isfahan University of Medical Sciences

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Fingolimod

Drug: Placebo (for Fish Oil)

Dietary Supplement: Fish Oil

Primary Outcome(s)

Serum Level of IL1b [Time Frame: 6 months after intervention]

Serum Level of IL6 [Time Frame: 6 months after intervention]

Serum Level of IFN-gamma [Time Frame: 1 year after intervention]

Serum Level of IFN-gamma [Time Frame: Baseline]

Serum Level of IL6 [Time Frame: 1 year after intervention]

Serum Level of IL1b [Time Frame: Baseline]

Serum Level of IFN-gamma [Time Frame: 6 months after intervention]

Serum Level of IL1b [Time Frame: 1 year after intervention]

Serum Level of IL6 [Time Frame: Baseline]

Serum Level of TNF-a [Time Frame: 6 months after intervention]

Serum Level of TNF-a [Time Frame: 1 year after intervention]

Serum Level of TNF-a [Time Frame: Baseline]

Secondary ID(s)

293396

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shiraz University of Medical Sciences

Results

• Results available: Yes
• Date Posted: 14/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02939079