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Trial record 1 of 1 for:    FTY 720 2306
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This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (INFORMS)

This study has been terminated.
(The extension study was terminated early after the results of the core study showed the study did not meet primary endpoint; confirmed disability progression)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731692
First Posted: August 11, 2008
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population

Condition Intervention Phase
Primary Progressive Multiple Sclerosis Drug: FTY720 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint [ Time Frame: up to 36 months after the last patient was randomized ]
    3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.


Secondary Outcome Measures:
  • Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS) [ Time Frame: up to 36 months after the last patient was randomized ]
    The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)

  • Percent Change From Baseline in Brain Volume at Month 36 [ Time Frame: Baseline to month 36 ]
    The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.

  • Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT. [ Time Frame: up to 36 months after the last patient was randomized ]
    The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis

  • Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT. [ Time Frame: up to 36 months after the last patient was randomized ]
    The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis

  • Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36 [ Time Frame: Baseline to 36 months ]
    Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis

  • Number of Gd-enhancing Lesions at Month 36 [ Time Frame: Baseline to 36 months ]
    Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis

  • Percent Change in Total T2 Lesion Volume From Baseline to Month 36 [ Time Frame: Baseline to month 36 ]
    Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis

  • Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score) [ Time Frame: Baseline, 36 months ]
    The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score

  • Change From Baseline in PRIMUS-Activities [ Time Frame: Baseline, 36 months ]
    The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).

  • Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score [ Time Frame: Baseline, 36 months ]
    Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).

  • Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score) [ Time Frame: Baseline, 36 months ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  • Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score) [ Time Frame: Baseline, 36 months ]
    The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).

  • Blood Concentrations of Fingolimod and Fingolimod-phosphate [ Time Frame: Month 3 up to 36 months ]

    Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.

    Venous blood samples were collected for the analysis.


  • Change in MSFC Z-score and Subscale Scores From Baseline to Month 36 [ Time Frame: Baseline to Month 36 ]
    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.


Enrollment: 970
Actual Study Start Date: July 28, 2008
Study Completion Date: June 22, 2015
Primary Completion Date: June 22, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTY720D 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment
Drug: FTY720
Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily
Placebo Comparator: Placebo
Cohort 1 and 2: Patients randomized to placebo continued on placebo after re-randomization
Drug: Placebo
Matching placebo capsules were administered orally once daily
Experimental: FTY720D 1.25 mg switch to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment on Nov 2009
Drug: FTY720
Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General

  1. sign written informed consent prior to participating in the study
  2. 25 through 65 years of age inclusive
  3. females of childbearing potential must:

    • have a negative pregnancy test at Baseline (prior to randomization) and
    • use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication

Primary Progressive Multiple sclerosis.

  1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):
  2. time since first reported symptoms between 2 and 10 years
  3. evidence of clinical disability progression in the 2 years prior to Screening
  4. disability status at Screening

    • EDSS score of 3.5-6.0 inclusive
    • pyramidal functional system score of 2 or more
    • 25'TWT less than 30 seconds

Extension study Inclusion criteria

  • Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to have completed at least 3 years on study drug treatment at the time of extension study initiation.
  • Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study

Exclusion Criteria:

PPMS specific:

  • History of relapses/attacks
  • Progressive neurological disorder other than PPMS
  • Pure cerebellar syndrome or pure visual progressive syndrome or pure
  • cognitive progressive syndrome
  • Presence of spinal cord compression at screening MRI
  • Relevant history of vitamin B12 deficit
  • Evidence of syphilis or borreliosis at Screening

Cardiovascular conditions:

  • Myocardial infarction within the past 6 months or current unstable ischemic heart disease
  • History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon
  • Severe cardiac failure or cardiac arrest
  • History of symptomatic bradycardia
  • Resting pulse <55 bpm pre-dose
  • History of sick sinus syndrome or sino-atrial heart block
  • History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms)
  • Arrythmia requiring treatment with class III antiarrythmic drugs
  • History of positive tilt test from workout of vasovagal syncope
  • Hypertension, not controlled with medication

Pulmonary:

  • Severe respiratory disease or pulmonary fibrosis
  • TB
  • Abnormal X-ray, suggestive of active pulmonary disease
  • Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO
  • Patients receiving chronic (daily) therapies for asthma

Hepatic:

  • Known history of alcohol abuse, chronic liver or biliary disease
  • Total or conjugated Brb >ULN, unless in context of Gilbert's syndrome
  • AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN

Other:

  • History of chronic disease of the immune system other than MS
  • Malignancy (other than successfully treated SCC or BCC)
  • Diabetes Mellitus
  • Macular Edema present at screening
  • HIV, Hepatitis C or B, other active infection
  • History of total lymphoid irradiation or bone marrow transplantation
  • Serum creatinine >1.7 mg/dl
  • WBC <3500 cells/mm3
  • Lymphocyte count <800 cells/mm3
  • History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures
  • Unable to undergo MRI scans
  • Participation in any therapeutical clinical research study in the 6 months prior to randomization
  • Pregnant or lactating women
  • Drugs requiring wash-out period:

    3 months:

    • Systemic corticosteroids or ACTH
    • INF-beta

      6 months:

    • Immunosuppressive medication
    • Immunoglobulins
    • Monoclonal antibodies
  • Drugs that exclude participation in the study:
  • Cladribine
  • Cyclophosphamide
  • Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)

Extension study Exclusion criteria

-Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731692


  Hide Study Locations
Locations
United States, California
Novartis Investigative Site
Newport Beach, California, United States, 92660
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Sacramento, California, United States, 95817
United States, Colorado
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Aurora, Colorado, United States, 80045
United States, Florida
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Pompano Beach, Florida, United States, 33060
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Tampa, Florida, United States, 33609
United States, Georgia
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Atlanta, Georgia, United States, 30302
United States, Illinois
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Chicago, Illinois, United States, 60611
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Chicago, Illinois, United States, 60637
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Kansas City, Kansas, United States, 66160
United States, Maryland
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Baltimore, Maryland, United States, 21287
United States, Massachusetts
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Boston, Massachusetts, United States, 02135
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Brookline, Massachusetts, United States, 02445
United States, Michigan
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Detroit, Michigan, United States, 48201
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Saint Louis, Missouri, United States, 63110
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Teaneck, New Jersey, United States, 07666
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Buffalo, New York, United States, 14203
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New York, New York, United States, 10029
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Rochester, New York, United States, 14642
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Stony Brook, New York, United States, 11794
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Charlotte, North Carolina, United States, 28207
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Durham, North Carolina, United States, 27705
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Cleveland, Ohio, United States, 44195
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Columbus, Ohio, United States, 43221
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Pittsburgh, Pennsylvania, United States, 15213
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Knoxville, Tennessee, United States, 37934
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Nashville, Tennessee, United States, 37212
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Dallas, Texas, United States, 75390-9034
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Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78229
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Burlington, Vermont, United States, 05401
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Charlottesville, Virginia, United States, 22904
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Seattle, Washington, United States, 98122
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Madison, Wisconsin, United States, 53792
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Camperdown, New South Wales, Australia, 2050
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Liverpool, New South Wales, Australia, 2170
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Heidelberg, Victoria, Australia, 3084
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Parkville, Victoria, Australia, 3050
Belgium
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Melsbroek, Belgium, 1820
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Sint-Truiden, Belgium, 3800
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Calgary, Alberta, Canada, T2N 2T9
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Edmonton, Alberta, Canada, T6R 2B7
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Burnaby, British Columbia, Canada, V5G 2X6
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Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
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Gatineau, Quebec, Canada, J9J 0A5
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Greenfield Park, Quebec, Canada, J4V 2J2
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Montreal, Quebec, Canada, H2L 4M1
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Montreal, Quebec, Canada, H3A 2B4
Canada, Saskatchewan
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Regina, Saskatchewan, Canada, S4T 1A5
Czechia
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Brno, Czech Republic, Czechia, 656 91
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Rychnov nad Kneznou, Czech Republic, Czechia, 516 01
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Olomouc, CZE, Czechia, 775 20
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Ostrava-Poruba, Czechia, 708 00
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Plzen, Czechia, 301 00
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Praha 2, Czechia, 128 08
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Teplice, Czechia, 415 29
Denmark
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Aarhus, Denmark, 8000 C
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Sønderborg, Denmark, 6400
Finland
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Helsinki, Finland, 00930
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Tampere, Finland, 33100
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Turku, Finland, 20520
France
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Bordeaux Cedex, France, F-33076
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Lille Cedex, France, 59037
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Marseille cedex 05, France, 13385
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Montpellier, France, 34295
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Nantes Cedex 1, France, 44093
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Paris Cedex 13, France, 75651
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Rennes, France, 35043
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Strasbourg, France, 67091
Germany
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Berlin, Germany, 10713
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Berlin, Germany, 13347
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Bochum, Germany, 44791
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Dresden, Germany, 01307
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Duesseldorf, Germany, D-40225
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Erlangen, Germany, 91054
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Essen, Germany, 45147
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Freiburg, Germany, 79106
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Hannover, Germany, 30625
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Hennigsdorf, Germany, 16761
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Magdeburg, Germany, 39120
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Muenchen, Germany, 81675
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Muenster, Germany, 48149
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Munchen, Germany, 81377
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Teupitz, Germany, 15755
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Trier, Germany, 54292
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Würzburg, Germany, 97080
Hungary
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Budapest, Hungary, 1076
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Budapest, Hungary, 1145
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Debrecen, Hungary, 4032
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Gyor, Hungary, 9024
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Miskolc, Hungary, 3526
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Veszprem, Hungary, H-8200
Italy
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Bari, BA, Italy, 70124
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Montichiari, BS, Italy, 25018
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Chieti, CH, Italy, 66100
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Catania, CT, Italy, 95123
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Genova, GE, Italy, 16132
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Milano, MI, Italy, 20122
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Milano, MI, Italy, 20132
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Cefalù, PA, Italy, 90015
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Padova, PD, Italy, 35128
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Roma, RM, Italy, 00133
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Roma, RM, Italy, 00189
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Orbassano, TO, Italy, 10043
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Gallarate, VA, Italy, 21013
Netherlands
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Breda, CK, Netherlands, 4818
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Amsterdam, Netherlands, 1105 AZ
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Eindhoven, Netherlands, 5623 EJ
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Nieuwegein, Netherlands, 3435 CM
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Nijmegen, Netherlands, 6525 GC
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Sittard-Geleen, Netherlands, 6162 BG
Poland
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Lodz, Poland, 90-153
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Lublin, Poland, 20-954
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Warszawa, Poland, 02-097
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Warszawa, Poland, 02-957
Spain
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Sevilla, Andalucia, Spain, 41009
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Badalona, Catalunya, Spain, 08916
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Barcelona, Catalunya, Spain, 08035
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Barcelona, Catalunya, Spain, 08036
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Girona, Catalunya, Spain, 17007
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L'Hospitalet de Llobregat, Catalunya, Spain, 08907
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Lleida, Catalunya, Spain, 25198
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Valencia, Comunidad Valenciana, Spain, 46026
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Majadahonda, Madrid, Spain, 28222
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Bilbao, Pais Vasco, Spain, 48013
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Madrid, Spain, 28040
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Madrid, Spain, 28046
Sweden
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Goeteborg, Sweden, 413 45
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Stockholm, Sweden, 17176
Switzerland
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Basel, Switzerland, 4031
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Bern, Switzerland, 3010
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Lausanne, Switzerland, 1011
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Lugano, Switzerland, 6900
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Zuerich, Switzerland, 8091
Turkey
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Ankara, Turkey, 06100
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Atakum / Samsun, Turkey, 55139
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Balcova / Izmir, Turkey, 35340
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Istanbul, Turkey, 34093
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Yenisehir / Izmir, Turkey
United Kingdom
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Salford, Manchester, United Kingdom, M6 8HD
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Sheffield, South Yorkshire, United Kingdom, S10 2JF
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Bristol, United Kingdom, BS10 5NB
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London, United Kingdom, EC1A 7BE
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London, United Kingdom, NW1 2BU
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London, United Kingdom, SE5 9RS
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London, United Kingdom, W8 6RF
Novartis Investigative Site
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Novartis Investigative Site
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00731692     History of Changes
Obsolete Identifiers: NCT01779934
Other Study ID Numbers: CFTY720D2306
2007-002627-32 ( EudraCT Number )
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: December 16, 2015
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
FTY720, primary progressive multiple sclerosis,PPMS

Additional relevant MeSH terms:
Fingolimod Hydrochloride
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs