A Phase 3 interventional study of Fingolimod and Placebo in Multiple Sclerosis, sponsored by Novartis. Completed at 113 sites in 8 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).
This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an Extension phase which consisted of a dose-blinded period and an open-label period.
In the Core phase, patients were randomized to receive a fixed dose of fingolimod (0.5 mg/day), fingolimod (1.25 mg/day) or placebo for up to 24 months.
For the Extension phase, patients who were treated with fingolimod during the Core phase continued treatment at the assigned dose level, while those previously treated with placebo during the Core phase were re-randomized in a 1:1 ratio to receive one of the two doses of fingolimod (1.25 mg or 0.5 mg). All patients in the extension received blinded investigational drug: fingolimod 1.25 mg and 0.5 mg in capsules for oral administration once daily until the decision to discontinue the fingolimod 1.25 mg dose became effective and subsequently all patients were switched to open-label fingolimod 0.5 mg.
With the implementation of Amendment 11, the 1.25 mg dose was discontinued and all patients were switched to fingolimod 0.5 mg dose. With the implementation of Amendment 12, all patients treated with Placebo in the fingolimod Core phase were switched to treatment with 0.5 mg fingolimod per day. The Extension phase continued until all patients either discontinued or transferred to Study CFTY720D2399 (NCT01201356; initiated in September 2010).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 1,083 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
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Exclusion Criteria:
For inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.
Other protocol-defined inclusion/exclusion criteria may apply.
Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally once a day. Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
Drug: Fingolimod
Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
Drug: Fingolimod
Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
Drug: Placebo
Fingolimod capsules for oral administration
Also known as: FTY720, Gilenya®
Matching placebo capsules for oral administration.
Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24
ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist). ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).
Time frame: 24 months
Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study
ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist). ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).
Time frame: From Baseline until end of study (up to approximately 54 months).
Percent Change From Baseline in Brain Volume
Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.
Time frame: Baseline, Month 24 and end of study (up to approximately 54 months)
Number of New or Newly Enlarged T2 Lesions
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.
Time frame: From Baseline until Month 48
Number of Gadolinium-enhanced T1 Lesions
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
Time frame: Month 24 and end of study (up to approximately 54 months)
Change From Baseline in Lesion Volume at Month 24 (Core Phase)
Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.
Time frame: Baseline and Month 24
Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study
Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.
Time frame: 24 months and end of study (up to approximately 54 months)
Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study
Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.
Time frame: 24 months and end of study (up to approximately 54 months)
Percentage of Participants Relapse-free up to Month 24
Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.
Time frame: 24 months
Percentage of Participants Relapse-free up to End of Study
Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.
Time frame: From Baseline until the end of study (up to approximately 54 months)
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score
The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.
Time frame: Baseline, Month 24 and end of study (up to approximately 54 months)
| Milestone | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo (Core) | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg |
|---|---|---|---|---|---|
| Started | 370 | 358 | 355 | 0 | 0 |
| Completed | 251 | 272 | 255 | 0 | 0 |
| Not completed | 119 | 86 | 100 | 0 | 0 |
| Withdrew: Withdrawal by subject | 35 | 24 | 35 | 0 | 0 |
| Withdrew: Adverse event | 28 | 22 | 16 | 0 | 0 |
| Withdrew: Lost to follow-up | 17 | 13 | 21 | 0 | 0 |
| Withdrew: Abnormal laboratory value(s) | 19 | 14 | 2 | 0 | 0 |
| Withdrew: Unsatisfactory therapeutic effect | 10 | 6 | 17 | 0 | 0 |
| Withdrew: Administrative problems | 5 | 3 | 5 | 0 | 0 |
| Withdrew: Protocol violation | 3 | 2 | 2 | 0 | 0 |
| Withdrew: Abnormal test procedure result(s) | 1 | 2 | 1 | 0 | 0 |
| Withdrew: Condition no longer requires study drug | 1 | 0 | 1 | 0 | 0 |
| Milestone | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo (Core) | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg |
|---|---|---|---|---|---|
| Started | 203 | 217 | 0 | 105 | 107 |
| Completed | 172 | 180 | 0 | 89 | 88 |
| Not completed | 31 | 37 | 0 | 16 | 19 |
| Withdrew: Withdrawal by subject | 7 | 11 | 0 | 7 | 5 |
| Withdrew: Adverse event | 13 | 9 | 0 | 3 | 5 |
| Withdrew: Lost to follow-up | 2 | 6 | 0 | 2 | 4 |
| Withdrew: Abnormal laboratory value(s) | 4 | 2 | 0 | 2 | 2 |
| Withdrew: Administrative problems | 2 | 4 | 0 | 1 | 1 |
| Withdrew: Unsatisfactory therapeutic effect | 3 | 4 | 0 | 0 | 1 |
| Withdrew: Abnormal test procedure result(s) | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 | 0 |
ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist). ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).
| relapses per year | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 | 0.203 (0.165 to 0.249) | 0.208 (0.170 to 0.254) | 0.403 (0.342 to 0.475) |
ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist). ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).
| relapses per year | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study | 0.180 (0.147 to 0.222) | 0.192 (0.157 to 0.234) | 0.363 (0.305 to 0.431) |
Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.
| percent change | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Month 24 [N=247; 266; 249] | -0.595 ± 1.3897 | -0.858 ± 1.2215 | -1.279 ± 1.5028 |
| End of study [N=178; 187; 182] | -1.130 ± 1.6380 | -1.266 ± 1.6941 | -1.694 ± 1.9567 |
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.
| lesions | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Core Phase (Month 0 to 24) [N=245; 264; 251] | 1.6 ± 5.41 | 2.3 ± 7.26 | 8.9 ± 13.86 |
| Month 24 to 36 [N=103; 111; 102] | 0.63 ± 2.856 | 0.45 ± 1.360 | 0.63 ± 1.455 |
| Month 36 to 48 [N=24; 15; 15] | 0.13 ± 0.448 | 0.07 ± 0.258 | 2.53 ± 8.741 |
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
| lesions | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Core Phase (Month 24) [N=251; 269; 256] | 0.24 ± 2.395 | 0.37 ± 1.841 | 1.22 ± 2.967 |
| End of Extension study [N=184; 194; 184] | 0.46 ± 2.381 | 0.09 ± 0.308 | 0.45 ± 3.618 |
Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.
| mm^3 | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| T2 lesions [N=248, 266, 251] | -436.92 ± 1557.820 | -223.27 ± 1405.459 | 541.83 ± 2830.868 |
| T1 hypointense lesions [N=247, 266, 248] | -99.13 ± 391.210 | -111.28 ± 530.961 | -37.68 ± 671.708 |
Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.
| percentage of participants | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| At month 24 | 78.3 (73.74 to 82.87) | 74.7 (69.86 to 79.52) | 71.0 (65.94 to 76.13) |
| At end of study | 66.64 (59.81 to 73.47) | 58.89 (48.98 to 68.80) | 63.51 (57.15 to 69.87) |
Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.
| percentage of participants | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| At Month 24 | 86.9 (83.16 to 90.61) | 86.2 (82.34 to 89.97) | 82.2 (77.90 to 86.44) |
| At end of study | 79.92 (74.43 to 85.41) | 74.89 (68.36 to 81.43) | 75.03 (69.59 to 80.47) |
Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.
| percentage of participants | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Relapse-free up to Month 24 | 73.2 (68.38 to 78.01) | 71.5 (66.55 to 76.44) | 52.7 (47.20 to 58.24) |
Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.
| percentage of participants | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Relapse-free up to End of Study | 63.88 (56.19 to 71.57) | 66.57 (60.86 to 72.28) | 49.12 (43.35 to 54.89) |
The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.
| units on a scale | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo |
|---|---|---|---|
| Month 24 [N=250; 271; 258] | -0.08 ± 0.916 | 0.00 ± 0.600 | -0.07 ± 0.540 |
| End of Study [N=174; 187; 184] | 0.011 ± 0.3499 | -0.091 ± 0.8770 | 0.019 ± 0.6304 |
Collected over Duration of treatment was up to 24 months during the Core phase, and dependent on the length of patient participation during the Extension phase (up to approximately 54 months overall duration of treatment).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Core: Fingolimod 1.25 mg | — | 53/370 (14.3%) | 335/370 (90.5%) |
| Core: Fingolimod 0.5 mg | — | 53/358 (14.8%) | 320/358 (89.4%) |
| Core: Placebo | — | 45/355 (12.7%) | 305/355 (85.9%) |
| Extension: Fingolimod 1.25 mg | — | 27/308 (8.8%) | 216/308 (70.1%) |
| Extension: Fingolimod 0.5 mg | — | 21/324 (6.5%) | 223/324 (68.8%) |
| Event | Core: Fingolimod 1.25 mg | Core: Fingolimod 0.5 mg | Core: Placebo | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg |
|---|---|---|---|---|---|
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/370 | 9/358 | 2/355 | 0/308 | 1/324 |
| BradycardiaCardiac disorders | 6/370 | 0/358 | 1/355 | 2/308 | 0/324 |
| Multiple sclerosis relapseNervous system disorders | 2/370 | 1/358 | 3/355 | 2/308 | 5/324 |
| Major depressionPsychiatric disorders | 0/370 | 1/358 | 3/355 | 0/308 | 0/324 |
| ConvulsionNervous system disorders | 0/370 | 3/358 | 1/355 | 0/308 | 0/324 |
| NephrolithiasisRenal and urinary disorders | 0/370 | 3/358 | 0/355 | 0/308 | 0/324 |
| Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/370 | 1/358 | 2/355 | 1/308 | 1/324 |
| Angina pectorisCardiac disorders | 1/370 | 0/358 | 2/355 | 1/308 | 0/324 |
| Abdominal painGastrointestinal disorders | 1/370 | 2/358 | 2/355 | 0/308 | 0/324 |
| CholelithiasisHepatobiliary disorders | 0/370 | 1/358 | 2/355 | 0/308 | 1/324 |
| Event | Core: Fingolimod 1.25 mg | Core: Fingolimod 0.5 mg | Core: Placebo | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 92/370 | 87/358 | 86/355 | 49/308 | 40/324 |
| NasopharyngitisInfections and infestations | 88/370 | 84/358 | 85/355 | 50/308 | 52/324 |
| HeadacheNervous system disorders | 81/370 | 83/358 | 76/355 | 25/308 | 29/324 |
| NauseaGastrointestinal disorders | 57/370 | 63/358 | 54/355 | 13/308 | 14/324 |
| SinusitisInfections and infestations | 45/370 | 55/358 | 45/355 | 31/308 | 27/324 |
| Urinary tract infectionInfections and infestations | 45/370 | 47/358 | 54/355 | 23/308 | 24/324 |
| CoughRespiratory, thoracic and mediastinal disorders | 51/370 | 52/358 | 53/355 | 23/308 | 24/324 |
| DizzinessNervous system disorders | 53/370 | 38/358 | 43/355 | 10/308 | 11/324 |
| DiarrhoeaGastrointestinal disorders | 52/370 | 48/358 | 43/355 | 13/308 | 16/324 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 46/370 | 34/358 | 33/355 | 6/308 | 6/324 |
| Age Continuous(years) | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo (Core) | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 40.9 ± 8.90 | 40.6 ± 8.39 | 40.1 ± 8.42 | NA ± NA | NA ± NA | 40.5 ± 8.58 |
| Age Continuous(years) | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo (Core) | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 40.6 ± 8.71 | 40.8 ± 7.96 | NA ± NA | 39.8 ± 8.32 | 41.1 ± 8.11 | 40.6 ± 8.28 |
| Gender(participants) | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo (Core) | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg | Total |
|---|---|---|---|---|---|---|
| Female | 281 | 275 | 288 | 0 | 0 | 844 |
| Male | 89 | 83 | 67 | 0 | 0 | 239 |
| Gender(participants) | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Placebo (Core) | Extension: Fingolimod 1.25 mg | Extension: Fingolimod 0.5 mg | Total |
|---|---|---|---|---|---|---|
| Female | 148 | 160 | 0 | 88 | 85 | 481 |
| Male | 55 | 57 | 0 | 17 | 22 | 151 |
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