A Phase 2 interventional study of Fingolimod and placebo in Schizophrenia, sponsored by Indiana University. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Indiana University · Phase 2, Interventional, and Treatment
This will be a single site safety and proof of concept study conducted at the Indiana University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo for duration of 8 weeks.
Study Design:
This will be a single site safety and proof of concept study conducted at the Indiana University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo for duration of 8 weeks.
All subjects will be admitted to the Indiana Clinical and Translational Sciences Institute Clinical Research Center (CRC) and remain hospitalized for the first 24 (+/- 2) hours post initial dose of study medication. The CRC is located in Indiana University Hospital and has 24 hour staffing with nurses skilled in conducting Phase 1 and Phase 2 investigational drug studies.
Background and Rationale:
Schizophrenia is a severe brain disorder that begins during the teenage years and early twenties and typically progresses to a life-long chronic illness marked by psychotic symptoms, cognitive impairment and poor functioning. A leading hypothesis to account for the symptoms and cognitive dysfunction of this disorder is that abnormalities exist in cortical circuits, particularly in frontal and temporal areas. An interest in cortical circuitry has led to a focus on the integrity of cortical white matter tracts as possibly contributing to the pathophysiology of this illness. Indeed, several lines of evidence have supported abnormalities in white matter structure and function in schizophrenia. Numerous myelin-related genes and their functional expression have been associated with schizophrenia. Moreover, quantitative and qualitative abnormalities in prefrontal cortical oligodendrocytes have been found in postmortem studies. MRI-determined volumetric reductions in prefrontal white matter have been reported in schizophrenia. Advances in MRI technology have enhanced the ability to study white matter pathology in vivo. Diffusion tensor imaging (DTI) and fractional anisotropy (FA) provides an assessment of the density and integrity of white matter tracts. Decreased FA has been reported in many de-myelinating diseases including multiple sclerosis (MS), leukodystrophies, and HIV. Numerous studies using DTI have reported decrements in FA in schizophrenia with the most consistent abnormalities occurring in frontal cortical white matter. Also, FA has been shown to be sensitive to therapeutic drug effects in MS which supports DTI-derived FA as an outcome measure in clinical trials of neuroprotective agents.
Fingolimod (FTY720, approved as Gilenya™ ) is a sphingosine-1-phosphate (S1P) receptor modulator and recently licensed in the USA and several other countries for relapsing forms of multiple sclerosis (MS). It is administered as a once per day oral preparation. In registration clinical trials, it had positive effects on brain atrophy, MRI-determined axonal lesions and relapse rates. Significant improvement in the mean number of MRI assessed T1 gadolinium (Gd) enhanced lesions/patient and the percentage of patients free of T1 Gd-enhanced lesions was observed within 6 months of treatment and there was evidence of clinical improvement as early as 2 months after treatment initiation
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinical stability:
Sub-optimally treated positive OR negative symptoms as defined by the Brief Psychiatric Rating Scale (BPRS):
Exclusion
0.5mg of fingolimod, oral administration, daily, for 8 weeks.
Drug: Fingolimod
placebo, oral administration, daily, for 8 weeks.
Drug: placebo
0.5mg each day of 8 week cycle
Also known as: gilenya
1 tablet each day of 8 week cycle
Also known as: sugar pill
QTcB Change
To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value.
Time frame: Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112
Levels of Lymphocyte
To determine the safety of fingolimod, as measured by the absolute lymphocyte count
Time frame: Baseline, 4 weeks, 8 weeks
Symptom Changes - PANSS Total Score
The 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.
Time frame: Baseline, 4 weeks, 8 weeks
Verbal Memory - BACS
The 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.
Time frame: Baseline, 4 weeks, 8 weeks
Cognition Change - BACS
The 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.
Time frame: Baseline, 4 weeks, 8 weeks
Cognition Change - Trails B
The 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.
Time frame: Baseline, 4 weeks, 8 weeks
Positive Symptom Change - PANSS
The 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.
Time frame: Baseline, 4 weeks, 8 weeks
Negative Symptom Change - PANSS
The 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.
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IL-10
To assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IL-17A
To assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IL-1BETA
To assess IL-1BETA plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IL-2
To assess IL-2 plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IL-4
To assess IL-4 plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IL-6
To assess IL-6 plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IL-8
To assess IL-8 plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - TNFa
To assess TNFa plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
Plasma Cytokines Levels - IFNgamma
To assess IFNgamma plasma cytokines levels changes in participants taking fingolimod versus placebo
Time frame: Baseline, 4 weeks, 8 weeks
| Milestone | Fingolimod | Placebo |
|---|---|---|
| Started | 18 | 22 |
| Completed | 14 | 17 |
| Not completed | 4 | 5 |
| Withdrew: Adverse event | 4 | 3 |
| Withdrew: Withdrawal by subject | 0 | 2 |
To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value.
| ms | Fingolimod | Placebo |
|---|---|---|
| QTcB - Screening | 416.50 ± 19.24 | 416.41 ± 17.69 |
| QTcB - Day 0 | 418.39 ± 23.47 | 423.27 ± 22.05 |
| QTcB - Day 7 | 415.50 ± 16.71 | 417.00 ± 19.99 |
| QTcB - Day 14 | 418.28 ± 16.30 | 420.15 ± 16.24 |
| QTcB - Day 21 | 419.67 ± 18.90 | 412.00 ± 19.25 |
| QTcB - Day 28 | 424.06 ± 17.51 | 415.74 ± 18.26 |
| QTcB - Day 35 | 426.18 ± 25.31 | 419.00 ± 20.47 |
| QTcB - Day 42 | 425.53 ± 22.10 | 414.33 ± 17.81 |
| QTcB - Day 49 | 420.79 ± 24.50 | 413.53 ± 18.02 |
| QTcB - Day 56 | 420.67 ± 21.25 | 418.41 ± 18.38 |
| QTcB - Day 84 | 421.50 ± 26.18 | 420.68 ± 22.69 |
| QTcB - Day 112 | 419.67 ± 20.22 | 418.58 ± 18.88 |
To determine the safety of fingolimod, as measured by the absolute lymphocyte count
| 10^3 lymphocytes/uL | Fingolimod | Placebo |
|---|---|---|
| Absolute lymphocyte count - Baseline | 1.99 ± 0.57 | 1.97 ± 0.64 |
| Absolute lymphocyte count - 4 weeks | 0.44 ± 0.22 | 1.94 ± 0.47 |
| Absolute lymphocyte count - 8 weeks | 0.49 ± 0.32 | 2.00 ± 0.76 |
The 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.
| score on a scale | Fingolimod | Placebo |
|---|---|---|
| PANSS Total Score - Baseline | 48.89 ± 11.58 | 56.50 ± 11.17 |
| PANSS Total Score - 4 weeks | 49.78 ± 14.69 | 53.60 ± 12.17 |
| PANSS Total Score - 8 weeks | 49.06 ± 14.65 | 54.94 ± 11.53 |
The 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.
| score on a scale | Fingolimod | Placebo |
|---|---|---|
| BACS Verbal Memory - Baseline | 30.89 ± 9.61 | 37.45 ± 11.65 |
| BACS Verbal Memory - 4 weeks | 33.50 ± 8.87 | 35.45 ± 9.56 |
| BACS Verbal Memory - 8 weeks | 34.69 ± 10.62 | 36.11 ± 11.53 |
The 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.
| score on a scale | Fingolimod | Placebo |
|---|---|---|
| BACS Composite Score - Baseline | 25.17 ± 14.75 | 30.95 ± 9.48 |
| BACS Composite Score - 4 weeks | 27.67 ± 13.61 | 32.10 ± 10.64 |
| BACS Composite Score - 8 weeks | 31.13 ± 12.52 | 33.50 ± 11.45 |
The 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.
| seconds | Fingolimod | Placebo |
|---|---|---|
| Trails B - Baseline | 108.00 ± 51.86 | 123.64 ± 71.11 |
| Trails B - 4 weeks | 97.88 ± 40.57 | 100.60 ± 48.02 |
| Trails B - 8 weeks | 84.53 ± 28.79 | 102.33 ± 74.48 |
The 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.
| score on a scale | Fingolimod | Placebo |
|---|---|---|
| PANSS Positive Score - Baseline | 10.83 ± 4.94 | 13.64 ± 5.59 |
| PANSS Positive Score - 4 weeks | 11.89 ± 6.24 | 14.00 ± 5.52 |
| PANSS Positive Score - 8 weeks | 10.06 ± 4.74 | 13.06 ± 5.40 |
The 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.
| score on a scale | Fingolimod | Placebo |
|---|---|---|
| PANSS Negative Score - Baseline | 15.00 ± 4.79 | 16.59 ± 5.32 |
| PANSS Negative Score - 4 weeks | 13.89 ± 3.53 | 14.80 ± 5.20 |
| PANSS Negative Score - 8 weeks | 15.44 ± 4.35 | 15.06 ± 4.67 |
To assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IL10 - Baseline | 16.11 ± 20.81 | 11.94 ± 13.38 |
| IL10 - 4 weeks | 15.50 ± 20.67 | 9.23 ± 10.68 |
| IL10 - 8 weeks | 16.28 ± 20.96 | 10.42 ± 9.84 |
To assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IL17A - Baseline | 3.09 ± 3.03 | 3.72 ± 6.87 |
| IL17A - 4 weeks | 2.58 ± 2.39 | 2.43 ± 2.15 |
| IL17A - 8 weeks | 2.58 ± 2.36 | 2.69 ± 2.27 |
To assess IL-1BETA plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IL1BETA - Baseline | 0.87 ± 0.81 | 0.69 ± 0.53 |
| IL1BETA - 4 weeks | 0.81 ± 0.82 | 0.72 ± 0.63 |
| IL1BETA - 8 weeks | 0.82 ± 0.76 | 0.74 ± 0.68 |
To assess IL-2 plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IL2 - Baseline | 1.74 ± 2.42 | 1.27 ± 1.43 |
| IL2 - 4 weeks | 1.96 ± 2.95 | 1.20 ± 1.63 |
| IL2 - 8 weeks | 1.77 ± 2.55 | 1.20 ± 1.24 |
To assess IL-4 plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IL4 - Baseline | 30.99 ± 30.86 | 30.74 ± 33.76 |
| IL4 - 4 weeks | 27.40 ± 23.61 | 31.34 ± 31.24 |
| IL4 - 8 weeks | 24.20 ± 24.57 | 32.16 ± 34.78 |
To assess IL-6 plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IL6 - Baseline | 2.15 ± 2.28 | 1.90 ± 1.75 |
| IL6 - 4 weeks | 2.22 ± 2.62 | 1.81 ± 1.99 |
| IL6 - 8 weeks | 2.16 ± 2.66 | 1.96 ± 1.56 |
To assess IL-8 plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IL8 - Baseline | 4.29 ± 5.55 | 3.83 ± 4.63 |
| IL8 - 4 weeks | 3.81 ± 3.71 | 3.69 ± 4.28 |
| IL8 - 8 weeks | 4.18 ± 4.77 | 3.69 ± 4.00 |
To assess TNFa plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| TNFa - Baseline | 2.11 ± 2.16 | 1.76 ± 1.32 |
| TNFa - 4 weeks | 2.02 ± 2.77 | 1.86 ± 1.38 |
| TNFa - 8 weeks | 2.00 ± 2.19 | 1.61 ± 1.09 |
To assess IFNgamma plasma cytokines levels changes in participants taking fingolimod versus placebo
| pg/ml | Fingolimod | Placebo |
|---|---|---|
| IFNgamma - Baseline | 5.32 ± 4.17 | 8.32 ± 16.21 |
| IFNgamma - 4 weeks | 4.61 ± 3.54 | 4.95 ± 3.70 |
| IFNgamma - 8 weeks | 4.32 ± 3.38 | 5.62 ± 4.40 |
Collected over Screening through day 112. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fingolimod | 0/18 (0%) | 0/18 (0%) | 18/18 (100%) |
| Placebo | 0/22 (0%) | 2/22 (9.1%) | 13/22 (59.1%) |
| Event | Fingolimod | Placebo |
|---|---|---|
| Hospitalization for exacerbation of schizophreniaPsychiatric disorders | 0/18 | 1/22 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/18 | 1/22 |
| Event | Fingolimod | Placebo |
|---|---|---|
| LymphocytopeniaBlood and lymphatic system disorders | 18/18 | 1/22 |
| Elevated Liver EnzymesHepatobiliary disorders | 5/18 | 0/22 |
| Asymptomatic BradycardiaCardiac disorders | 3/18 | 3/22 |
| diarrheaGastrointestinal disorders | 3/18 | 2/22 |
| headacheGeneral disorders | 3/18 | 2/22 |
| Blurry visionEye disorders | 3/18 | 0/22 |
| HyponatremiaBlood and lymphatic system disorders | 0/18 | 3/22 |
| QTc Interval ProlongationCardiac disorders | 2/18 | 0/22 |
| NeutropeniaBlood and lymphatic system disorders | 2/18 | 0/22 |
| Dry mouthGeneral disorders | 2/18 | 0/22 |
| Age, Categorical(Participants) | Fingolimod | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 22 | 40 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Fingolimod | Placebo | Total |
|---|---|---|---|
| Mean | 36.33 ± 10.28 | 37.00 ± 13.19 | 36.70 ± 11.83 |
| Sex: Female, Male(Participants) | Fingolimod | Placebo | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 12 | 16 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Fingolimod | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 16 | 21 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Fingolimod | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 12 | 21 |
| White | 8 | 8 | 16 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Fingolimod | Placebo | Total |
|---|---|---|---|
| United States | 18 | 22 | 40 |
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Indiana University