Trial Outcomes & Findings for Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients (NCT NCT02939079)
NCT ID: NCT02939079
Last Updated: 2019-05-14
Results Overview
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.
COMPLETED
PHASE2/PHASE3
50 participants
Baseline
2019-05-14
Participant Flow
The recruitment period started on April 2015. 74 patients were screened initially and 50 of them were recruited. All the patients were recruited from the neurology department of Kashani hospital, Isfahan, iran. They were patients referred to the neurology department (multiple sclerosis clinic) for evaluation and treatment.
After recruitment, no medication was prescribed for the patients for two months as the wash-out period. Then patients were assigned to study groups.
Participant milestones
| Measure |
Fingolimod and Fish Oil
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Fingolimod and Fish Oil
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
relapse during the study
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.19 years
STANDARD_DEVIATION 9.97 • n=21 Participants
|
31.40 years
STANDARD_DEVIATION 8.41 • n=20 Participants
|
33.34 years
STANDARD_DEVIATION 9.21 • n=41 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=21 Participants
|
16 Participants
n=20 Participants
|
29 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=21 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Iran
|
21 participants
n=21 Participants
|
20 participants
n=20 Participants
|
41 participants
n=41 Participants
|
|
Dietary habits, Categorical (seafood meals per month)
0-1 meals per month
|
19 Participants
n=21 Participants
|
18 Participants
n=20 Participants
|
37 Participants
n=41 Participants
|
|
Dietary habits, Categorical (seafood meals per month)
2-4 meals per month
|
2 Participants
n=21 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=41 Participants
|
|
Dietary habits, Categorical (seafood meals per month)
>4 meals per month
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
|
EDSS
|
3.10 units on a scale
STANDARD_DEVIATION 1.28 • n=21 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 1.38 • n=20 Participants
|
2.83 units on a scale
STANDARD_DEVIATION 1.33 • n=41 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Per-protocol analysis
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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of TNF-α
|
37.16 Pg/ml
Standard Deviation 92.74
|
28.79 Pg/ml
Standard Deviation 47.46
|
PRIMARY outcome
Timeframe: Baseline5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IL1b
|
13.76 Pg/ml
Standard Deviation 0.74
|
14 Pg/ml
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Baseline5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IL6
|
6.19 Pg/ml
Standard Deviation 0.35
|
6.33 Pg/ml
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Baseline5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IFN-gamma
|
6.38 Pg/ml
Standard Deviation 1.51
|
6.98 Pg/ml
Standard Deviation 3.87
|
PRIMARY outcome
Timeframe: 6 months after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of TNF-α
|
28.03 Pg/ml
Standard Deviation 60.36
|
17.18 Pg/ml
Standard Deviation 18.88
|
PRIMARY outcome
Timeframe: 1 year after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of TNF-α
|
21.20 Pg/ml
Standard Deviation 36.45
|
16.47 Pg/ml
Standard Deviation 16.64
|
PRIMARY outcome
Timeframe: 6 months after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IL1b
|
13.61 Pg/ml
Standard Deviation 0.58
|
13.47 Pg/ml
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 1 year after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IL1b
|
13.17 Pg/ml
Standard Deviation 0.52
|
13.15 Pg/ml
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: 6 months after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IL6
|
6.65 Pg/ml
Standard Deviation 2.11
|
6.17 Pg/ml
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: 1 year after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IL6
|
6.17 Pg/ml
Standard Deviation 0.76
|
6.05 Pg/ml
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: 6 months after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IFN-gamma
|
5.71 Pg/ml
Standard Deviation 0.57
|
6.37 Pg/ml
Standard Deviation 1.77
|
PRIMARY outcome
Timeframe: 1 year after intervention5 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.
Outcome measures
| Measure |
Fingolimod and Fish Oil
n=21 Participants
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=20 Participants
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Serum Level of IFN-gamma
|
5.92 Pg/ml
Standard Deviation 1.31
|
5.99 Pg/ml
Standard Deviation 0.84
|
Adverse Events
Fingolimod and Fish Oil
Fingolimod and Placebo
Serious adverse events
| Measure |
Fingolimod and Fish Oil
n=25 participants at risk
Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Fish Oil: produced by Zahravi ® Pharm Company in Iran
|
Fingolimod and Placebo
n=25 participants at risk
Fingolimod 0.5 mg capsule daily by mouth and Placebo capsule daily by mouth for one year.
Fingolimod: Produced by Osveh ® Pharm Company in Iran
Placebo (for Fish Oil): placebo capsules to mimic Fish Oil 1 g capsules
|
|---|---|---|
|
Cardiac disorders
Hypotension and bradycardia
|
8.0%
2/25 • Number of events 2 • Patients were evaluated in the study for one year and were observed for adverse events during this period.
Adverse events were collected through follow up phone calls and visits.
|
8.0%
2/25 • Number of events 2 • Patients were evaluated in the study for one year and were observed for adverse events during this period.
Adverse events were collected through follow up phone calls and visits.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vahid Shaygannejad
Isfahan University of Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place