search
Back to results

Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS II)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fingolimod
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring fingolimod, FTY720, relapsing-remitting multiple sclerosis, MS, RRMS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis Patients with a relapsing-remitting disease course Patients with expanded disability status scale (EDSS) score of 0-5.5 Exclusion Criteria: Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. Pregnant or nursing women 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.

Sites / Locations

  • University of Alabama Birmingham
  • North Central Neurology Associates, PC
  • University of South Alabama - Dept of Neurology
  • Barrow Neurology Clinic
  • Research and Education Institute of Alta Bates Summit Medical Center
  • University of California - Irvine, Deptarment of Neurology
  • Cedars Sinai Medical Center
  • The Neurology Center
  • Neuro-Therapeutics, Inc.
  • UC Davis Medical Center
  • Multiple Sclerosis Center at UCSF
  • University of Colorado
  • Associated Neurologists, PC
  • Associated Neurologists of Southern CT, P.C.
  • Yale University - Yale Multiple Sclerosis Center
  • Georgetown University Hospital - Dept of Neurology
  • Sunrise Clinical Research, Inc.
  • University of Florida Health Sciences Center/Shands Jacksonville
  • Neurology Associates, PA
  • University of Miami, Department of Neurology
  • Neurological Associates
  • Roskamp Institute, Clinical Trials Division
  • Neurology Clinical Research, Inc
  • AMO Corporation
  • Axiom Clinical Research of Florida
  • The MS Center of Vero Beach
  • MS Center of Atlanta
  • Medical College of Georgia
  • Northwestern University Medical School - Dept of Neurology
  • Rush University Medical Center Department of Neurological Sciences
  • University of Chicago - Dept of Neurology
  • Alexian Brothers Neurosciences Research
  • South Suburban Neurology
  • Neurologic Associates, Ltd.
  • Fort Wayne Neurological Center
  • Indiana University Medical Center
  • Ruan Neurology Clinical Research Center
  • University of Kansas Medical Center
  • Mid America Neuroscience Institute
  • Kentucky Research Associates
  • University of Maryland
  • Johns Hopkins MS Center
  • Caritas St. Elizabeth's Medical Center
  • Newton Wesley Hospital
  • Springfield Neurology
  • UMass Memorial Medical Center
  • University of Michigan Mulitiple Sclerosis Clinic
  • Wayne State University MS Clinic
  • Henry Ford Hospital, Department of Neurology
  • Michigan State University MS Clinic
  • Michigan Medical, P.C.
  • Michigan Neurology Associates, PC
  • St. Luke's Hospital - Mid-America Brain and Stroke Institute
  • The MS Center for Innovation in Care
  • Institute for Neurosciences
  • Multiple Sclerosis Center
  • Gimbel Multiple Sclerosis Center at Holy Name Hospital
  • University of New Mexico Health Science Center
  • Empire Neurology, PC
  • NYU Hospital for Joint Diseases
  • Cornell University - NY Presbyterian Hospital
  • Mount Sinai School of Medicine
  • Island Neurological Associates, PC
  • University of Rochester Medical Center
  • Alpha Neurology
  • SUNY Stony Brook
  • SUNY Upstate Medical University
  • UNC - Chapel Hill Neuroscience Hospital
  • Duke University Medical Center
  • Raleigh Neurology Associates
  • Wake Forest University Baptist Medical Center
  • Neurology & Neuroscience Associates, Inc.
  • Northern Ohio Neuroscience, LLC.
  • NeuroCare Center, Inc
  • River Hills Health Care
  • Ohio State University
  • University of Toledo Health Science Campus
  • Oak Clinic
  • MS Center of Oklahoma, Mercy Neuroscience Institute
  • Neurologial Associates of Tulsa
  • Oregon Neurology
  • University of Pennsylvania, Department of Neurology
  • Thomas Jefferson University Hospital, Department of Neurology
  • Allegheny Neurological Associates
  • University of Pittsburgh - Dept of Neurology
  • Absher Neurology
  • Mountain Empire Neurological Associates, PC
  • Advanced Neurosciences Institute
  • Vanderbilt Stallworth Rehabilitation Hospital
  • University of Texas - Houston Medical School
  • Investigational Site - Private Practice
  • Integra Clinical Research, LLC
  • Neurology Health Care Service - Fletcher Allen Hospital
  • University of Virginia - Fontaine Adult Neurology
  • Virginia Mason Multiple Sclerosis Center
  • Seattle Neuroscience Institute at Swedish Medical Center
  • University Health Associates - West Virgina University
  • Dean Foundation
  • University of Wisconsin Medical School
  • St. Luke's Medical Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Fingolimod 1.25 mg

Fingolimod 0.5 mg

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 19, 2006
Last Updated
August 2, 2012
Sponsor
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00355134
Brief Title
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Acronym
FREEDOMS II
Official Title
24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
fingolimod, FTY720, relapsing-remitting multiple sclerosis, MS, RRMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1083 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod 1.25 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Fingolimod 0.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Other Intervention Name(s)
FTY720, Gilenya®
Intervention Description
Fingolimod capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules for oral administration.
Primary Outcome Measure Information:
Title
Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24
Description
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
Secondary Outcome Measure Information:
Title
Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study
Description
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).
Title
Percent Change From Baseline in Brain Volume
Description
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)
Title
Number of New or Newly Enlarged T2 Lesions
Description
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
Title
Number of Gadolinium-enhanced T1 Lesions
Description
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)
Title
Change From Baseline in Lesion Volume at Month 24 (Core Phase)
Description
Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.
Time Frame
Baseline and Month 24
Title
Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study
Description
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)
Title
Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study
Description
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)
Title
Percentage of Participants Relapse-free up to Month 24
Description
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
Title
Percentage of Participants Relapse-free up to End of Study
Description
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)
Title
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis Patients with a relapsing-remitting disease course Patients with expanded disability status scale (EDSS) score of 0-5.5 Exclusion Criteria: Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. Pregnant or nursing women 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
North Central Neurology Associates, PC
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
University of South Alabama - Dept of Neurology
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Barrow Neurology Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research and Education Institute of Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
University of California - Irvine, Deptarment of Neurology
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
The Neurology Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Neuro-Therapeutics, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Multiple Sclerosis Center at UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Associated Neurologists, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Associated Neurologists of Southern CT, P.C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Yale University - Yale Multiple Sclerosis Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Hospital - Dept of Neurology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Sunrise Clinical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Florida Health Sciences Center/Shands Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Neurology Associates, PA
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami, Department of Neurology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Neurological Associates
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Roskamp Institute, Clinical Trials Division
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Neurology Clinical Research, Inc
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
AMO Corporation
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
The MS Center of Vero Beach
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
MS Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University Medical School - Dept of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center Department of Neurological Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago - Dept of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Alexian Brothers Neurosciences Research
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
South Suburban Neurology
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Facility Name
Neurologic Associates, Ltd.
City
Palos Heights
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ruan Neurology Clinical Research Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mid America Neuroscience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Kentucky Research Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins MS Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Newton Wesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Springfield Neurology
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worchester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Michigan Mulitiple Sclerosis Clinic
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University MS Clinic
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital, Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan State University MS Clinic
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Michigan Medical, P.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Michigan Neurology Associates, PC
City
St. Clair Shores
State/Province
Michigan
ZIP/Postal Code
48080
Country
United States
Facility Name
St. Luke's Hospital - Mid-America Brain and Stroke Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The MS Center for Innovation in Care
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Institute for Neurosciences
City
Reno
State/Province
Nevada
ZIP/Postal Code
85902
Country
United States
Facility Name
Multiple Sclerosis Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Gimbel Multiple Sclerosis Center at Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
NYU Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cornell University - NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Island Neurological Associates, PC
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Alpha Neurology
City
Staten Island
State/Province
New York
ZIP/Postal Code
10306
Country
United States
Facility Name
SUNY Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
UNC - Chapel Hill Neuroscience Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Neurology & Neuroscience Associates, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Northern Ohio Neuroscience, LLC.
City
Bellevue
State/Province
Ohio
ZIP/Postal Code
44811
Country
United States
Facility Name
NeuroCare Center, Inc
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
River Hills Health Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
48221
Country
United States
Facility Name
University of Toledo Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oak Clinic
City
Uniontown
State/Province
Ohio
ZIP/Postal Code
44685
Country
United States
Facility Name
MS Center of Oklahoma, Mercy Neuroscience Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Neurologial Associates of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
Oregon Neurology
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
University of Pennsylvania, Department of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital, Department of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh - Dept of Neurology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Absher Neurology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Mountain Empire Neurological Associates, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt Stallworth Rehabilitation Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
University of Texas - Houston Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site - Private Practice
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Integra Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Neurology Health Care Service - Fletcher Allen Hospital
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia - Fontaine Adult Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Mason Multiple Sclerosis Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
Seattle Neuroscience Institute at Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University Health Associates - West Virgina University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Dean Foundation
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
University of Wisconsin Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Novartis Investigative Site
City
North Gosford
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Vienna
Country
Austria
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Novartis Investigative Site
City
Bialystok
Country
Poland
Facility Name
Novartis Investigative Site
City
Warsaw
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
Country
Poland
Facility Name
Novartis Investigative Site
City
Bucharest
Country
Romania
Facility Name
Novartis Investigative Site
City
Targu Mures
Country
Romania
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Yenisehir/Izmir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Bristol
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36286605
Citation
Wang L, Tan H, Yu J, ZhangBao J, Huang W, Chang X, Zhou L, Lu C, Xiao Y, Lu J, Zhao C, Wang M, Wu X, Wu M, Dong Q, Ngew KY, Quan C. Baseline retinal nerve fiber layer thickness as a predictor of multiple sclerosis progression: New insights from the FREEDOMS II study. Eur J Neurol. 2023 Feb;30(2):443-452. doi: 10.1111/ene.15612. Epub 2022 Nov 15.
Results Reference
derived
PubMed Identifier
27733070
Citation
Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.
Results Reference
derived
PubMed Identifier
26121423
Citation
Derfuss T, Bergvall NK, Sfikas N, Tomic DL. Efficacy of fingolimod in patients with highly active relapsing-remitting multiple sclerosis. Curr Med Res Opin. 2015;31(9):1687-91. doi: 10.1185/03007995.2015.1067191. Epub 2015 Aug 20.
Results Reference
derived
PubMed Identifier
25245812
Citation
Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.
Results Reference
derived
PubMed Identifier
24685276
Citation
Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT, Vollmer T, Agius MA, Kappos L, Stites T, Li B, Cappiello L, von Rosenstiel P, Lublin FD. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Jun;13(6):545-56. doi: 10.1016/S1474-4422(14)70049-3. Epub 2014 Mar 28. Erratum In: Lancet Neurol. 2013 Jun;13(6):536.
Results Reference
derived
PubMed Identifier
24051419
Citation
Winges KM, Werner JS, Harvey DJ, Cello KE, Durbin MK, Balcer LJ, Calabresi PA, Keltner JL. Baseline retinal nerve fiber layer thickness and macular volume quantified by OCT in the North American phase 3 fingolimod trial for relapsing-remitting multiple sclerosis. J Neuroophthalmol. 2013 Dec;33(4):322-9. doi: 10.1097/WNO.0b013e31829c51f7.
Results Reference
derived
Links:
URL
http://www.msclinicaltrials.com
Description
Fingolimod clinical trials information website

Learn more about this trial

Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

We'll reach out to this number within 24 hrs