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Multiple SclerosisPhase 3FREEDOMS IINCT00355134

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

A Phase 3 study testing Fingolimod in people with Multiple Sclerosis, run by Novartis at 112 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Fingolimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,083 participants
Where
112 sitesin 8 countries
Study dates
Jun 2006to Aug 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

112 sites in 8 countries.

112 sites in 8 countries

United States100 sites

  • Neurology & Neuroscience Associates, Inc.

    Akron, Ohio, 44302

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico, 87131

  • University of Michigan Mulitiple Sclerosis Clinic

    Ann Arbor, Michigan, 48109

  • MS Center of Atlanta

    Atlanta, Georgia, 30327

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins MS Center

    Baltimore, Maryland, 21287

  • Northern Ohio Neuroscience, LLC.

    Bellevue, Ohio, 44811

  • Research and Education Institute of Alta Bates Summit Medical Center

    Berkeley, California, 94705

  • University of Alabama Birmingham

    Birmingham, Alabama, 35249

  • Caritas St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Mountain Empire Neurological Associates, PC

    Bristol, Tennessee, 37620

  • Neurology Health Care Service - Fletcher Allen Hospital

    Burlington, Vermont, 05401

  • NeuroCare Center, Inc

    Canton, Ohio, 44718

  • UNC - Chapel Hill Neuroscience Hospital

    Chapel Hill, North Carolina, 27599

  • University of Virginia - Fontaine Adult Neurology

    Charlottesville, Virginia, 22903

  • Northwestern University Medical School - Dept of Neurology

    Chicago, Illinois, 60611

  • Rush University Medical Center Department of Neurological Sciences

    Chicago, Illinois, 60612

  • University of Chicago - Dept of Neurology

    Chicago, Illinois, 60637

  • River Hills Health Care

    Cincinnati, Ohio, 45219

  • Ohio State University

    Columbus, Ohio, 48221

  • North Central Neurology Associates, PC

    Cullman, Alabama, 35058

  • Associated Neurologists, PC

    Danbury, Connecticut, 06810

  • University of Colorado

    Denver, Colorado, 80262

  • Ruan Neurology Clinical Research Center

    Des Moines, Iowa, 50314

  • Wayne State University MS Clinic

    Detroit, Michigan, 48201

  • Henry Ford Hospital, Department of Neurology

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Michigan State University MS Clinic

    East Lansing, Michigan, 48824

  • Alexian Brothers Neurosciences Research

    Elk Grove Village, Illinois, 60007

  • Associated Neurologists of Southern CT, P.C.

    Fairfield, Connecticut, 06824

  • South Suburban Neurology

    Flossmoor, Illinois, 60402

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • Michigan Medical, P.C.

    Grand Rapids, Michigan, 49525

  • Absher Neurology

    Greenville, South Carolina, 29615

  • Sunrise Clinical Research, Inc.

    Hollywood, Florida, 33021

  • University of Texas - Houston Medical School

    Houston, Texas, 77030

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • University of California - Irvine, Deptarment of Neurology

    Irvine, California, 92697

  • University of Florida Health Sciences Center/Shands Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • St. Luke's Hospital - Mid-America Brain and Stroke Institute

    Kansas City, Missouri, 64111

  • Empire Neurology, PC

    Latham, New York, 12110

  • Multiple Sclerosis Center

    Lebanon, New Hampshire, 03756

  • Mid America Neuroscience Institute

    Lenexa, Kansas, 66214

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Kentucky Research Associates

    Louisville, Kentucky, 40202

  • Investigational Site - Private Practice

    Lubbock, Texas, 79410

  • Dean Foundation

    Madison, Wisconsin, 53715

  • University of Wisconsin Medical School

    Madison, Wisconsin, 53792

  • Neurology Associates, PA

    Maitland, Florida, 32751

  • University of Miami, Department of Neurology

    Miami, Florida, 33136

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • University of South Alabama - Dept of Neurology

    Mobile, Alabama, 36693

  • University Health Associates - West Virgina University

    Morgantown, West Virginia, 26506

  • Advanced Neurosciences Institute

    Nashville, Tennessee, 37205

  • Vanderbilt Stallworth Rehabilitation Hospital

    Nashville, Tennessee, 37212

  • Yale University - Yale Multiple Sclerosis Center

    New Haven, Connecticut, 06510

  • NYU Hospital for Joint Diseases

    New York, New York, 10003

  • Cornell University - NY Presbyterian Hospital

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Newton Wesley Hospital

    Newton, Massachusetts, 02462

  • The Neurology Center

    Oceanside, California, 92056

  • MS Center of Oklahoma, Mercy Neuroscience Institute

    Oklahoma City, Oklahoma, 73120

  • Neurologic Associates, Ltd.

    Palos Heights, Illinois, 60453

  • Neuro-Therapeutics, Inc.

    Pasadena, California, 91105

  • University of Pennsylvania, Department of Neurology

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital, Department of Neurology

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurology Clinic

    Phoenix, Arizona, 85013

  • Allegheny Neurological Associates

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh - Dept of Neurology

    Pittsburgh, Pennsylvania, 15213

  • Island Neurological Associates, PC

    Plainview, New York, 11803

  • Neurological Associates

    Pompano Beach, Florida, 33060

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Institute for Neurosciences

    Reno, Nevada, 85902

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Michigan Neurology Associates, PC

    Saint Clair Shores, Michigan, 48080

  • Integra Clinical Research, LLC

    San Antonio, Texas, 78231

  • Multiple Sclerosis Center at UCSF

    San Francisco, California, 94117

  • Roskamp Institute, Clinical Trials Division

    Sarasota, Florida, 34243

  • Virginia Mason Multiple Sclerosis Center

    Seattle, Washington, 98111

  • Seattle Neuroscience Institute at Swedish Medical Center

    Seattle, Washington, 98122

  • Springfield Neurology

    Springfield, Massachusetts, 01104

  • The MS Center for Innovation in Care

    St Louis, Missouri, 63110

  • Alpha Neurology

    Staten Island, New York, 10306

  • SUNY Stony Brook

    Stony Brook, New York, 11794

  • Neurology Clinical Research, Inc

    Sunrise, Florida, 33351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • AMO Corporation

    Tallahassee, Florida, 32308

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Gimbel Multiple Sclerosis Center at Holy Name Hospital

    Teaneck, New Jersey, 07666

  • University of Toledo Health Science Campus

    Toledo, Ohio, 43614

  • Oregon Neurology

    Tualatin, Oregon, 97062

  • Neurologial Associates of Tulsa

    Tulsa, Oklahoma, 74137

  • Oak Clinic

    Uniontown, Ohio, 44685

  • The MS Center of Vero Beach

    Vero Beach, Florida, 32960

  • Georgetown University Hospital - Dept of Neurology

    Washington D.C., District of Columbia, 20007

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center

    Worchester, Massachusetts, 01605

Other trials in United States

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Istanbul

  • Novartis Investigative Site

    Izmir

  • Novartis Investigative Site

    Yenisehir/Izmir

Other trials in Turkey (Türkiye)

Canada2 sites

  • Novartis Investigative Site

    Greenfield Park, Quebec

  • Novartis Investigative Site

    Ottawa, Ontario

Other trials in Canada

Poland2 sites

  • Novartis Investigative Site

    Bialystok

  • Novartis Investigative Site

    Warsaw

Other trials in Poland

Romania2 sites

  • Novartis Investigative Site

    Bucharest

  • Novartis Investigative Site

    Târgu Mureş

Other trials in Romania

Australia1 site

  • Novartis Investigative Site

    North Gosford, New South Wales

Other trials in Australia

Austria1 site

  • Novartis Investigative Site

    Vienna

Other trials in Austria

United Kingdom1 site

  • Novartis Investigative Site

    Bristol

Other trials in United Kingdom

About this study

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

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).

Read the 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).

Being tested
Fingolimod, Placebo
Keywords
fingolimod, FTY720, relapsing-remitting multiple sclerosis, MS, RRMS
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FingolimodDrug

    Also called FTY720, Gilenya®

    Fingolimod capsules for oral administration

  • PlaceboDrug

    Matching placebo capsules for oral administration.

Study groups in NCT00355134
Study groupRoleWhat they receive
Fingolimod 1.25 mgExperimentalParticipants 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.
Receives: Drug: Fingolimod
Fingolimod 0.5 mgExperimentalParticipants 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.
Receives: Drug: Fingolimod
PlaceboExperimentalParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 24 months

Secondary outcomes (10)

  1. 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).

    Measured: From Baseline until end of study (up to approximately 54 months).

  2. 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.

    Measured: Baseline, Month 24 and end of study (up to approximately 54 months)

  3. 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.

    Measured: From Baseline until Month 48

  4. 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.

    Measured: Month 24 and end of study (up to approximately 54 months)

  5. 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.

    Measured: Baseline and Month 24

  6. 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.

    Measured: 24 months and end of study (up to approximately 54 months)

  7. 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.

    Measured: 24 months and end of study (up to approximately 54 months)

  8. 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.

    Measured: 24 months

  9. 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.

    Measured: From Baseline until the end of study (up to approximately 54 months)

  10. 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.

    Measured: Baseline, Month 24 and end of study (up to approximately 54 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJun 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,083 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355134
Sponsor's protocol ID
CFTY720D2309
Acronym
FREEDOMS II
Status last verified
Aug 2012
First submitted
19 Jul 2006
Last updated
7 Aug 2012
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36286605

  • 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.

    PubMed 27733070

  • 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.

    PubMed 26121423

  • 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.

    PubMed 25245812

  • 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.

    PubMed 24685276

  • 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.

    PubMed 24051419

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fingolimod in people with Multiple Sclerosis, run by Novartis at 112 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Turkey (Türkiye), Canada, Poland, Romania and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00355134, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.

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