Trial Outcomes & Findings for Fingolimod in Schizophrenia Patients (NCT NCT01779700)
NCT ID: NCT01779700
Last Updated: 2019-04-16
Results Overview
To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value.
COMPLETED
PHASE2
40 participants
Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112
2019-04-16
Participant Flow
Participant milestones
| Measure |
Fingolimod
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Fingolimod
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Fingolimod in Schizophrenia Patients
Baseline characteristics by cohort
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36.33 years
STANDARD_DEVIATION 10.28 • n=99 Participants
|
37.00 years
STANDARD_DEVIATION 13.19 • n=107 Participants
|
36.70 years
STANDARD_DEVIATION 11.83 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
22 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value.
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
QTcB Change
QTcB - Day 7
|
415.50 ms
Standard Deviation 16.71
|
417.00 ms
Standard Deviation 19.99
|
|
QTcB Change
QTcB - Day 14
|
418.28 ms
Standard Deviation 16.30
|
420.15 ms
Standard Deviation 16.24
|
|
QTcB Change
QTcB - Day 21
|
419.67 ms
Standard Deviation 18.90
|
412.00 ms
Standard Deviation 19.25
|
|
QTcB Change
QTcB - Day 28
|
424.06 ms
Standard Deviation 17.51
|
415.74 ms
Standard Deviation 18.26
|
|
QTcB Change
QTcB - Day 35
|
426.18 ms
Standard Deviation 25.31
|
419.00 ms
Standard Deviation 20.47
|
|
QTcB Change
QTcB - Day 42
|
425.53 ms
Standard Deviation 22.10
|
414.33 ms
Standard Deviation 17.81
|
|
QTcB Change
QTcB - Day 49
|
420.79 ms
Standard Deviation 24.50
|
413.53 ms
Standard Deviation 18.02
|
|
QTcB Change
QTcB - Day 56
|
420.67 ms
Standard Deviation 21.25
|
418.41 ms
Standard Deviation 18.38
|
|
QTcB Change
QTcB - Day 84
|
421.50 ms
Standard Deviation 26.18
|
420.68 ms
Standard Deviation 22.69
|
|
QTcB Change
QTcB - Day 112
|
419.67 ms
Standard Deviation 20.22
|
418.58 ms
Standard Deviation 18.88
|
|
QTcB Change
QTcB - Screening
|
416.50 ms
Standard Deviation 19.24
|
416.41 ms
Standard Deviation 17.69
|
|
QTcB Change
QTcB - Day 0
|
418.39 ms
Standard Deviation 23.47
|
423.27 ms
Standard Deviation 22.05
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo determine the safety of fingolimod, as measured by the absolute lymphocyte count
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Levels of Lymphocyte
Absolute lymphocyte count - Baseline
|
1.99 10^3 lymphocytes/uL
Standard Deviation 0.57
|
1.97 10^3 lymphocytes/uL
Standard Deviation 0.64
|
|
Levels of Lymphocyte
Absolute lymphocyte count - 4 weeks
|
0.44 10^3 lymphocytes/uL
Standard Deviation 0.22
|
1.94 10^3 lymphocytes/uL
Standard Deviation 0.47
|
|
Levels of Lymphocyte
Absolute lymphocyte count - 8 weeks
|
0.49 10^3 lymphocytes/uL
Standard Deviation 0.32
|
2.00 10^3 lymphocytes/uL
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksThe Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Symptom Changes - PANSS Total Score
PANSS Total Score - Baseline
|
48.89 score on a scale
Standard Deviation 11.58
|
56.50 score on a scale
Standard Deviation 11.17
|
|
Symptom Changes - PANSS Total Score
PANSS Total Score - 4 weeks
|
49.78 score on a scale
Standard Deviation 14.69
|
53.60 score on a scale
Standard Deviation 12.17
|
|
Symptom Changes - PANSS Total Score
PANSS Total Score - 8 weeks
|
49.06 score on a scale
Standard Deviation 14.65
|
54.94 score on a scale
Standard Deviation 11.53
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksThe Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition. The BACS utilizes 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic\&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Verbal Memory - BACS
BACS Verbal Memory - Baseline
|
30.89 score on a scale
Standard Deviation 9.61
|
37.45 score on a scale
Standard Deviation 11.65
|
|
Verbal Memory - BACS
BACS Verbal Memory - 4 weeks
|
33.50 score on a scale
Standard Deviation 8.87
|
35.45 score on a scale
Standard Deviation 9.56
|
|
Verbal Memory - BACS
BACS Verbal Memory - 8 weeks
|
34.69 score on a scale
Standard Deviation 10.62
|
36.11 score on a scale
Standard Deviation 11.53
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksThe Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic\&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Cognition Change - BACS
BACS Composite Score - Baseline
|
25.17 score on a scale
Standard Deviation 14.75
|
30.95 score on a scale
Standard Deviation 9.48
|
|
Cognition Change - BACS
BACS Composite Score - 4 weeks
|
27.67 score on a scale
Standard Deviation 13.61
|
32.10 score on a scale
Standard Deviation 10.64
|
|
Cognition Change - BACS
BACS Composite Score - 8 weeks
|
31.13 score on a scale
Standard Deviation 12.52
|
33.50 score on a scale
Standard Deviation 11.45
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksThe Trail Making Test-Part B (Trails B) is a measure of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. In Part B version the subject alternates between numbers and letters (1, A, 2, B, etc.) The goal of the test is for the subject is to finish part B as quickly as possible, the time taken to complete the test is used as the primary performance metric. The score is the number of seconds it took to complete the test.
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Cognition Change - Trails B
Trails B - Baseline
|
108.00 seconds
Standard Deviation 51.86
|
123.64 seconds
Standard Deviation 71.11
|
|
Cognition Change - Trails B
Trails B - 4 weeks
|
97.88 seconds
Standard Deviation 40.57
|
100.60 seconds
Standard Deviation 48.02
|
|
Cognition Change - Trails B
Trails B - 8 weeks
|
84.53 seconds
Standard Deviation 28.79
|
102.33 seconds
Standard Deviation 74.48
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksThe Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Positive Symptom Change - PANSS
PANSS Positive Score - Baseline
|
10.83 score on a scale
Standard Deviation 4.94
|
13.64 score on a scale
Standard Deviation 5.59
|
|
Positive Symptom Change - PANSS
PANSS Positive Score - 4 weeks
|
11.89 score on a scale
Standard Deviation 6.24
|
14.00 score on a scale
Standard Deviation 5.52
|
|
Positive Symptom Change - PANSS
PANSS Positive Score - 8 weeks
|
10.06 score on a scale
Standard Deviation 4.74
|
13.06 score on a scale
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksThe Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Negative Symptom Change - PANSS
PANSS Negative Score - Baseline
|
15.00 score on a scale
Standard Deviation 4.79
|
16.59 score on a scale
Standard Deviation 5.32
|
|
Negative Symptom Change - PANSS
PANSS Negative Score - 4 weeks
|
13.89 score on a scale
Standard Deviation 3.53
|
14.80 score on a scale
Standard Deviation 5.20
|
|
Negative Symptom Change - PANSS
PANSS Negative Score - 8 weeks
|
15.44 score on a scale
Standard Deviation 4.35
|
15.06 score on a scale
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IL-10
IL10 - Baseline
|
16.11 pg/ml
Standard Deviation 20.81
|
11.94 pg/ml
Standard Deviation 13.38
|
|
Plasma Cytokines Levels - IL-10
IL10 - 4 weeks
|
15.50 pg/ml
Standard Deviation 20.67
|
9.23 pg/ml
Standard Deviation 10.68
|
|
Plasma Cytokines Levels - IL-10
IL10 - 8 weeks
|
16.28 pg/ml
Standard Deviation 20.96
|
10.42 pg/ml
Standard Deviation 9.84
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IL-17A
IL17A - Baseline
|
3.09 pg/ml
Standard Deviation 3.03
|
3.72 pg/ml
Standard Deviation 6.87
|
|
Plasma Cytokines Levels - IL-17A
IL17A - 4 weeks
|
2.58 pg/ml
Standard Deviation 2.39
|
2.43 pg/ml
Standard Deviation 2.15
|
|
Plasma Cytokines Levels - IL-17A
IL17A - 8 weeks
|
2.58 pg/ml
Standard Deviation 2.36
|
2.69 pg/ml
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IL-1BETA plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IL-1BETA
IL1BETA - Baseline
|
0.87 pg/ml
Standard Deviation 0.81
|
0.69 pg/ml
Standard Deviation 0.53
|
|
Plasma Cytokines Levels - IL-1BETA
IL1BETA - 4 weeks
|
0.81 pg/ml
Standard Deviation 0.82
|
0.72 pg/ml
Standard Deviation 0.63
|
|
Plasma Cytokines Levels - IL-1BETA
IL1BETA - 8 weeks
|
0.82 pg/ml
Standard Deviation 0.76
|
0.74 pg/ml
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IL-2 plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IL-2
IL2 - Baseline
|
1.74 pg/ml
Standard Deviation 2.42
|
1.27 pg/ml
Standard Deviation 1.43
|
|
Plasma Cytokines Levels - IL-2
IL2 - 4 weeks
|
1.96 pg/ml
Standard Deviation 2.95
|
1.20 pg/ml
Standard Deviation 1.63
|
|
Plasma Cytokines Levels - IL-2
IL2 - 8 weeks
|
1.77 pg/ml
Standard Deviation 2.55
|
1.20 pg/ml
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IL-4 plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IL-4
IL4 - Baseline
|
30.99 pg/ml
Standard Deviation 30.86
|
30.74 pg/ml
Standard Deviation 33.76
|
|
Plasma Cytokines Levels - IL-4
IL4 - 4 weeks
|
27.40 pg/ml
Standard Deviation 23.61
|
31.34 pg/ml
Standard Deviation 31.24
|
|
Plasma Cytokines Levels - IL-4
IL4 - 8 weeks
|
24.20 pg/ml
Standard Deviation 24.57
|
32.16 pg/ml
Standard Deviation 34.78
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IL-6 plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IL-6
IL6 - Baseline
|
2.15 pg/ml
Standard Deviation 2.28
|
1.90 pg/ml
Standard Deviation 1.75
|
|
Plasma Cytokines Levels - IL-6
IL6 - 4 weeks
|
2.22 pg/ml
Standard Deviation 2.62
|
1.81 pg/ml
Standard Deviation 1.99
|
|
Plasma Cytokines Levels - IL-6
IL6 - 8 weeks
|
2.16 pg/ml
Standard Deviation 2.66
|
1.96 pg/ml
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IL-8 plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IL-8
IL8 - Baseline
|
4.29 pg/ml
Standard Deviation 5.55
|
3.83 pg/ml
Standard Deviation 4.63
|
|
Plasma Cytokines Levels - IL-8
IL8 - 4 weeks
|
3.81 pg/ml
Standard Deviation 3.71
|
3.69 pg/ml
Standard Deviation 4.28
|
|
Plasma Cytokines Levels - IL-8
IL8 - 8 weeks
|
4.18 pg/ml
Standard Deviation 4.77
|
3.69 pg/ml
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess TNFa plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - TNFa
TNFa - Baseline
|
2.11 pg/ml
Standard Deviation 2.16
|
1.76 pg/ml
Standard Deviation 1.32
|
|
Plasma Cytokines Levels - TNFa
TNFa - 4 weeks
|
2.02 pg/ml
Standard Deviation 2.77
|
1.86 pg/ml
Standard Deviation 1.38
|
|
Plasma Cytokines Levels - TNFa
TNFa - 8 weeks
|
2.00 pg/ml
Standard Deviation 2.19
|
1.61 pg/ml
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksTo assess IFNgamma plasma cytokines levels changes in participants taking fingolimod versus placebo
Outcome measures
| Measure |
Fingolimod
n=18 Participants
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 Participants
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Plasma Cytokines Levels - IFNgamma
IFNgamma - 8 weeks
|
4.32 pg/ml
Standard Deviation 3.38
|
5.62 pg/ml
Standard Deviation 4.40
|
|
Plasma Cytokines Levels - IFNgamma
IFNgamma - Baseline
|
5.32 pg/ml
Standard Deviation 4.17
|
8.32 pg/ml
Standard Deviation 16.21
|
|
Plasma Cytokines Levels - IFNgamma
IFNgamma - 4 weeks
|
4.61 pg/ml
Standard Deviation 3.54
|
4.95 pg/ml
Standard Deviation 3.70
|
Adverse Events
Fingolimod
Placebo
Serious adverse events
| Measure |
Fingolimod
n=18 participants at risk
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 participants at risk
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for exacerbation of schizophrenia
|
0.00%
0/18 • Screening through day 112
|
4.5%
1/22 • Number of events 1 • Screening through day 112
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/18 • Screening through day 112
|
4.5%
1/22 • Number of events 1 • Screening through day 112
|
Other adverse events
| Measure |
Fingolimod
n=18 participants at risk
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Fingolimod: 0.5mg each day of 8 week cycle
|
Placebo
n=22 participants at risk
placebo, oral administration, daily, for 8 weeks.
placebo: 1 tablet each day of 8 week cycle
|
|---|---|---|
|
Cardiac disorders
Asymptomatic Bradycardia
|
16.7%
3/18 • Number of events 3 • Screening through day 112
|
13.6%
3/22 • Number of events 4 • Screening through day 112
|
|
Blood and lymphatic system disorders
Hyponatremia
|
0.00%
0/18 • Screening through day 112
|
13.6%
3/22 • Number of events 3 • Screening through day 112
|
|
Gastrointestinal disorders
diarrhea
|
16.7%
3/18 • Number of events 3 • Screening through day 112
|
9.1%
2/22 • Number of events 2 • Screening through day 112
|
|
General disorders
headache
|
16.7%
3/18 • Number of events 3 • Screening through day 112
|
9.1%
2/22 • Number of events 2 • Screening through day 112
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
4.5%
1/22 • Number of events 2 • Screening through day 112
|
|
Cardiac disorders
QTc Interval Prolongation
|
11.1%
2/18 • Number of events 2 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Cardiac disorders
Mobitz I AV Block
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Cardiac disorders
Sinus Tachycardia
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
4.5%
1/22 • Number of events 1 • Screening through day 112
|
|
Cardiac disorders
Hypertension, intermittent
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
100.0%
18/18 • Number of events 18 • Screening through day 112
|
4.5%
1/22 • Number of events 1 • Screening through day 112
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
2/18 • Number of events 2 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
27.8%
5/18 • Number of events 5 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Eye disorders
Blurry vision
|
16.7%
3/18 • Number of events 3 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
General disorders
Dry mouth
|
11.1%
2/18 • Number of events 2 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
General disorders
Exacerbation of Allergic Rhinitis
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
General disorders
Insomnia
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
General disorders
mood lability
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Psychiatric disorders
Increased auditory hallucinations
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
General disorders
Paresthesia
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
4.5%
1/22 • Number of events 1 • Screening through day 112
|
|
General disorders
Stuttering
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
General disorders
Dyskinetic Movement
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
|
Psychiatric disorders
Worsening of intermittent panic attacks
|
5.6%
1/18 • Number of events 1 • Screening through day 112
|
0.00%
0/22 • Screening through day 112
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place