This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 10 for:    Siponimod
Previous Study | Return to List | Next Study

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01665144
First received: August 3, 2012
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerabiilty and efficacy (Extension Part).

Condition Intervention Phase
Secondary Progressive Multiple Sclerosis Drug: BAF312 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The delay in time to confirmed disability progression as measured by EDSS. [ Time Frame: Baseline, every 3 month up to the maximum of approximately 3 years ]
    Confirmed disability is defined as an Increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.


Secondary Outcome Measures:
  • Efficacy of BAF312 relative to placebo in confirmed worsening of 25 foot walk test [ Time Frame: Baseline , every 3 months up to the maximum of approximately 3 years ]
    Delay in time to 3 month confirmed worsening of at least 20% from baseline in the timed 25 foot walk test.

  • Efficacy of BAF312 relative to placebo in reducing the increase in T2 lesion volume [ Time Frame: Baseline, every year up to the maximum of approximately 3 years ]
    The reduction of the increase in the T1 lesion volume.

  • The delay in time to confirmed disability progression as measured by EDSS. [ Time Frame: Baseline, every 6 months up to the maximum of approximately 3 years ]
    Confirmed disability is defined as increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.

  • Efficacy of BAF relative to placebo in annualized relapses rate and time to the first relapse [ Time Frame: Baseline every 3 months up to the maximum of approximately 3 years ]
    BAF312 vs placebo measured by the effect on confirmed relapses rate, the time to the first relapse, and proportion of patient free from relapses.

  • Overall response rate on the MSWS-12. [ Time Frame: Baseline, every 6 months up to the maximum of approximately 3 years ]
    The overall response of the effect of BAF312 compared to placebo patients on the patient reported outcome form MSWS-12.

  • Effect on inflammatory disease activity and burden of disease as measured by MRI [ Time Frame: Baseline, every 12 month up to the maximum of approximately 3 years ]
    Effect of BAF312 relative to placebo on disease activity and burden of disease as measured by Gd-T1 lesion, new/enlarged T2 lesion, and brain atrophy on brain MRI scans.

  • effect on 3-month confirmed disability progression as defined by EDSS in predefined sub-groups [ Time Frame: Baseline, every 3 months up to the maximum of approximately 3 years ]
    effect on confirmed disability progression in pre-defined subgroups, including patients with or without superimposed relapses, rapidly evolving patients with 1.5 point or greater change in EDSS score in 2 years prior to enrollment into the study. Patients with score of 4 or more in MSSS and those who don't meet this criteria.

  • Number of patients with adverse events during the Core Part [ Time Frame: Baseline, every 3 months up to the maximum of approximately 3 years ]
    Safety analysis will be performed on AE by CTCAE grade, serious AEs and Study drug related AEs and the AEs leading to discontinuation of study drug.

  • Number of patients with abnormal lab tests during the Core Part [ Time Frame: Baseline, every 3 months up to the maximum of approximately 3 years ]
    Safety analysis will be performed on lab abnormalities will be based on CTCAE grades

  • Number of patients with adverse events during the Extension Part [ Time Frame: Following the Core Part of the study, every 3 months for one year and then every 6 months up to the maximum of 84 months ]
    Safety analysis will be performed on AE by CTCAE grade, serious AEs and Study drug related AEs and the AEs leading to discontinuation of study drug.

  • Number of patients with abnormal lab tests during the Extension Part [ Time Frame: Following the Core Part of the study, every 3 months for the first year and then every 6 months up to the maximum of 84 months ]
    Safety analysis will be performed on lab abnormalities will be based on CTCAE grades


Estimated Enrollment: 1530
Actual Study Start Date: December 20, 2012
Estimated Study Completion Date: June 30, 2023
Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAF312
1090 patients will be randomized to receive BAF312 during the trial for a maximum of approximately 3 years (Core Part). Patients who meet all inclusion and none of the exclusion criteria will be treated with BAF312 daily. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312 for a maximum of 84 additional months.
Drug: BAF312
Patients will be randomized to receive BAF312. BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose.
Placebo Comparator: Placebo
Matching Placebo administered orally during the Core Part of the trial. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312 for a maximum of 84 additional months.
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior history of relapsing remitting MS
  • SPMS defined as progressive increase of disability over at least 6 months
  • EDSS score of 3.0 to 6.5
  • No relapse of corticosteroid treatment within 3 months

Exclusion Criteria:

  • Women of child bearing potential must use reliable forms of contraception.
  • Diagnosis of Macular edema during screening period
  • Any medically unstable condition determined by investigator.
  • Unable to undergo MRI scans
  • Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665144

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative Site Withdrawn
Cullman, Alabama, United States, 35058
United States, Arizona
Novartis Investigative Site Withdrawn
Phoenix, Arizona, United States, 85006
Novartis Investigative Site Completed
Phoenix, Arizona, United States, 85032
United States, California
Novartis Investigative Site Active, not recruiting
Berkeley, California, United States, 94705
Novartis Investigative Site Withdrawn
Loma Linda, California, United States, 92354
Novartis Investigative Site Active, not recruiting
Los Angeles, California, United States, 90033
Novartis Investigative Site Completed
Oceanside, California, United States, 92056
Novartis Investigative Site Terminated
Sacramento, California, United States, 95816
Novartis Investigative Site Active, not recruiting
Sacramento, California, United States, 95817
Novartis Investigative Site Terminated
Torrance, California, United States, 90509-2004
United States, Colorado
Novartis Investigative Site Active, not recruiting
Aurora, Colorado, United States, 80045
Novartis Investigative Site Completed
Basalt, Colorado, United States, 81621
Novartis Investigative Site Active, not recruiting
Boulder, Colorado, United States, 80301
Novartis Investigative Site Withdrawn
Centennial, Colorado, United States, 80112
Novartis Investigative Site Active, not recruiting
Colorado Springs, Colorado, United States, 80910
Novartis Investigative Site Completed
Englewood, Colorado, United States, 80113
United States, Connecticut
Novartis Investigative Site Withdrawn
Danbury, Connecticut, United States, 06810
Novartis Investigative Site Completed
Fairfield, Connecticut, United States, 06824
Novartis Investigative Site Withdrawn
North Haven, Connecticut, United States, 06473
United States, Florida
Novartis Investigative Site Active, not recruiting
Delray Beach, Florida, United States, 33445
Novartis Investigative Site Active, not recruiting
Jacksonville, Florida, United States, 32209
Novartis Investigative Site Active, not recruiting
Maitland, Florida, United States, 32751
Novartis Investigative Site Terminated
Miami, Florida, United States, 33136
Novartis Investigative Site Active, not recruiting
Ormond Beach, Florida, United States, 32174
Novartis Investigative Site Withdrawn
Pembroke Pines, Florida, United States, 33024
Novartis Investigative Site Active, not recruiting
Pompano Beach, Florida, United States, 33060
Novartis Investigative Site Active, not recruiting
Port Charlotte, Florida, United States, 33952
Novartis Investigative Site Terminated
St. Petersburg, Florida, United States, 33713
Novartis Investigative Site Withdrawn
Sunrise, Florida, United States, 33351
Novartis Investigative Site Terminated
Tallahassee, Florida, United States, 32308
Novartis Investigative Site Active, not recruiting
Tampa, Florida, United States, 33609
Novartis Investigative Site Active, not recruiting
Tampa, Florida, United States, 33612
Novartis Investigative Site Active, not recruiting
Vero Beach, Florida, United States, 32960
Novartis Investigative Site Withdrawn
West Palm Beach, Florida, United States, 33407
United States, Illinois
Novartis Investigative Site Active, not recruiting
Chicago, Illinois, United States, 60612
Novartis Investigative Site Terminated
Chicago, Illinois, United States, 60637
Novartis Investigative Site Active, not recruiting
Evanston, Illinois, United States, 60201
Novartis Investigative Site Completed
Flossmoor, Illinois, United States, 60422
United States, Kansas
Novartis Investigative Site Active, not recruiting
Lenexa, Kansas, United States, 66212
United States, Kentucky
Novartis Investigative Site Withdrawn
Louisville, Kentucky, United States, 40202
United States, Maryland
Novartis Investigative Site Withdrawn
Baltimore, Maryland, United States, 21201
Novartis Investigative Site Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Novartis Investigative Site Terminated
Lexington, Massachusetts, United States, 02421
Novartis Investigative Site Withdrawn
Worchester, Massachusetts, United States, 01608
United States, Michigan
Novartis Investigative Site Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Novartis Investigative Site Completed
Detroit, Michigan, United States, 48201
Novartis Investigative Site Active, not recruiting
Detroit, Michigan, United States, 48202
Novartis Investigative Site Terminated
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Novartis Investigative Site Active, not recruiting
Golden Valey, Minnesota, United States, 55422
United States, Missouri
Novartis Investigative Site Active, not recruiting
St. Louis, Missouri, United States, 63131
United States, Nevada
Novartis Investigative Site Active, not recruiting
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Novartis Investigative Site Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Novartis Investigative Site Active, not recruiting
Freehold, New Jersey, United States, 07728
Novartis Investigative Site Terminated
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Novartis Investigative Site Active, not recruiting
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
Novartis Investigative Site Terminated
Amherst, New York, United States, 14226
Novartis Investigative Site Withdrawn
Latham, New York, United States, 12110
Novartis Investigative Site Withdrawn
Mineola, New York, United States, 11501
Novartis Investigative Site Active, not recruiting
New York, New York, United States, 10016
Novartis Investigative Site Active, not recruiting
New York, New York, United States, 10029
Novartis Investigative Site Completed
Patchogue, New York, United States, 11772
Novartis Investigative Site Terminated
Plainview, New York, United States, 11803
Novartis Investigative Site Withdrawn
Rochester, New York, United States, 14642
Novartis Investigative Site Active, not recruiting
Stony Brook, New York, United States, 11794
Novartis Investigative Site Terminated
Syracuse, New York, United States, 13210
United States, North Carolina
Novartis Investigative Site Active, not recruiting
Charlotte, North Carolina, United States, 28207
Novartis Investigative Site Terminated
Charlotte, North Carolina, United States, 28209
Novartis Investigative Site Withdrawn
Durham, North Carolina, United States, 27710
United States, Ohio
Novartis Investigative Site Active, not recruiting
Akron, Ohio, United States, 44320
Novartis Investigative Site Withdrawn
Bellevue, Ohio, United States, 44811
Novartis Investigative Site Terminated
Cleveland, Ohio, United States, 44195
Novartis Investigative Site Active, not recruiting
Dayton, Ohio, United States, 45408
Novartis Investigative Site Withdrawn
Toledo, Ohio, United States, 43614
United States, Oklahoma
Novartis Investigative Site Withdrawn
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Novartis Investigative Site Active, not recruiting
Portland, Oregon, United States, 97225
Novartis Investigative Site Completed
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Novartis Investigative Site Withdrawn
Hershey, Pennsylvania, United States, 17033
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Novartis Investigative Site Active, not recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Novartis Investigative Site Terminated
Cordova, Tennessee, United States, 38018
United States, Texas
Novartis Investigative Site Active, not recruiting
Dallas, Texas, United States, 75216
Novartis Investigative Site Withdrawn
Kingwood, Texas, United States, 77339
Novartis Investigative Site Completed
Lubbock, Texas, United States, 79410
Novartis Investigative Site Active, not recruiting
San Antonio, Texas, United States, 78258
United States, Vermont
Novartis Investigative Site Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Novartis Investigative Site Terminated
Alexandria, Virginia, United States, 22310
United States, Washington
Novartis Investigative Site Completed
Seattle, Washington, United States, 98101
Novartis Investigative Site Completed
Seattle, Washington, United States, 98122
United States, Wisconsin
Novartis Investigative Site Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Argentina
Novartis Investigative Site Active, not recruiting
Caba, Buenos Aires, Argentina, 1425
Novartis Investigative Site Active, not recruiting
Caba, Buenos Aires, Argentina, C1181ACH
Novartis Investigative Site Active, not recruiting
Caba, Buenos Aires, Argentina, C1428AQK
Novartis Investigative Site Active, not recruiting
Capital Federal, Buenos Aires, Argentina, 1424
Novartis Investigative Site Active, not recruiting
Buenos Aires, Argentina, 1061
Novartis Investigative Site Active, not recruiting
Cordoba, Argentina, X5000FAL
Australia, New South Wales
Novartis Investigative Site Active, not recruiting
Camperdown, New South Wales, Australia, 2050
Novartis Investigative Site Active, not recruiting
Kogarah, New South Wales, Australia, 2217
Novartis Investigative Site Active, not recruiting
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Novartis Investigative Site Withdrawn
Box Hill, Victoria, Australia, 3128
Novartis Investigative Site Active, not recruiting
Heidelberg, Victoria, Australia, 3084
Novartis Investigative Site Active, not recruiting
Parkville, Victoria, Australia, 3050
Austria
Novartis Investigative Site Active, not recruiting
Klagenfurt, Austria, 9020
Novartis Investigative Site Active, not recruiting
Vienna, Austria, 1010
Novartis Investigative Site Active, not recruiting
Vienna, Austria, 1090
Belgium
Novartis Investigative Site Completed
Brugge, Belgium, 8000
Novartis Investigative Site Completed
Bruxelles, Belgium, 1070
Novartis Investigative Site Completed
Edegem, Belgium, 2650
Novartis Investigative Site Completed
Gent, Belgium, 9000
Novartis Investigative Site Completed
Leuven, Belgium, 3000
Novartis Investigative Site Completed
Overpelt, Belgium, 3900
Novartis Investigative Site Completed
Sijsele, Belgium, 8340
Novartis Investigative Site Completed
Tinlot (Fraiture), Belgium, 4557
Bulgaria
Novartis Investigative Site Active, not recruiting
Sofia, Bulgaria, 1113
Novartis Investigative Site Active, not recruiting
Sofia, Bulgaria, 1431
Novartis Investigative Site Active, not recruiting
Sofia, Bulgaria, 1612
Novartis Investigative Site Active, not recruiting
Varna, Bulgaria, 9010
Canada, Alberta
Novartis Investigative Site Active, not recruiting
Calgary, Alberta, Canada, T2N 2T9
Novartis Investigative Site Active, not recruiting
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
Novartis Investigative Site Completed
Burnaby, British Columbia, Canada, V5G 2X6
Canada, Nova Scotia
Novartis Investigative Site Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
Novartis Investigative Site Active, not recruiting
Kingston, Ontario, Canada, K7L 2V7
Novartis Investigative Site Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Novartis Investigative Site Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H2L 4M1
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H3A 2B4
Canada, Saskatchewan
Novartis Investigative Site Terminated
Regina, Saskatchewan, Canada, S4T 1A5
China, Beijing
Novartis Investigative Site Active, not recruiting
Beijing, Beijing, China, 100034
Novartis Investigative Site Active, not recruiting
Beijing, Beijing, China, 100730
China, Jilin
Novartis Investigative Site Active, not recruiting
Changchun, Jilin, China, 130021
China, Shanxi
Novartis Investigative Site Active, not recruiting
Taiyuan, Shanxi, China, 030001
Novartis Investigative Site Active, not recruiting
Xi'an, Shanxi, China, 710038
China, Sichuan
Novartis Investigative Site Active, not recruiting
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site Active, not recruiting
Beijing, China, 100028
Novartis Investigative Site Withdrawn
Beijing, China, 100176
Novartis Investigative Site Active, not recruiting
Beijing, China, 100730
Novartis Investigative Site Terminated
Shanghai, China, 200003
Novartis Investigative Site Active, not recruiting
Shanghai, China, 200040
Czech Republic
Novartis Investigative Site Active, not recruiting
Brno, Czech Rep., Czech Republic, 625 00
Novartis Investigative Site Active, not recruiting
JIhlava, Czech Republic, 586 01
Novartis Investigative Site Active, not recruiting
Prague 5, Czech Republic, 150 00
Novartis Investigative Site Active, not recruiting
Praha 2, Czech Republic, 128 08
Novartis Investigative Site Active, not recruiting
Teplice, Czech Republic, 415 01
Estonia
Novartis Investigative Site Completed
Tallinn, Estonia, 10138
Novartis Investigative Site Active, not recruiting
Tallinn, Estonia, 10617
France
Novartis Investigative Site Active, not recruiting
Nancy, Cedex, France, 54035
Novartis Investigative Site Active, not recruiting
Bordeaux Cedex, France, F-33076
Novartis Investigative Site Active, not recruiting
CAEN Cedex, France, 14033
Novartis Investigative Site Active, not recruiting
Lille Cedex, France, 59037
Novartis Investigative Site Active, not recruiting
Marseille, France, 13385
Novartis Investigative Site Recruiting
Montpellier, France, 34295
Novartis Investigative Site Active, not recruiting
Nimes, France, 30029
Novartis Investigative Site Active, not recruiting
Paris Cedex 13, France, 75651
Novartis Investigative Site Active, not recruiting
Rennes, France, 35043
Novartis Investigative Site Active, not recruiting
St Herblain, France, 44800
Novartis Investigative Site Active, not recruiting
Strasbourg, France, 67091
Germany
Novartis Investigative Site Active, not recruiting
Aschaffenburg, Germany, 63739
Novartis Investigative Site Active, not recruiting
Bad Mergentheim, Germany, 97980
Novartis Investigative Site Active, not recruiting
Bayreuth, Germany, 95445
Novartis Investigative Site Completed
Berg, Germany, 82335
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 10713
Novartis Investigative Site Completed
Berlin, Germany, 13347
Novartis Investigative Site Active, not recruiting
Bielefeld, Germany, 33647
Novartis Investigative Site Completed
Bochum, Germany, 44791
Novartis Investigative Site Active, not recruiting
Bonn, Germany, 53111
Novartis Investigative Site Active, not recruiting
Böblingen, Germany, 71032
Novartis Investigative Site Active, not recruiting
Dresden, Germany, 01307
Novartis Investigative Site Withdrawn
Duesseldorf, Germany, D-40225
Novartis Investigative Site Active, not recruiting
Erbach, Germany, 64711
Novartis Investigative Site Completed
Erlangen, Germany, 91054
Novartis Investigative Site Active, not recruiting
Frankfurt, Germany, 60313
Novartis Investigative Site Completed
Freiburg, Germany, 79106
Novartis Investigative Site Completed
Hamburg, Germany, 20249
Novartis Investigative Site Completed
Hamburg, Germany, 22083
Novartis Investigative Site Active, not recruiting
Hannover, Germany, 30171
Novartis Investigative Site Active, not recruiting
Hannover, Germany, 30625
Novartis Investigative Site Active, not recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Active, not recruiting
Homburg, Germany, 66421
Novartis Investigative Site Active, not recruiting
Itzehoe, Germany, 25524
Novartis Investigative Site Active, not recruiting
Jena, Germany, 07740
Novartis Investigative Site Active, not recruiting
Kassel, Germany, 34121
Novartis Investigative Site Active, not recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Active, not recruiting
Leipzig, Germany, 04107
Novartis Investigative Site Active, not recruiting
Muenchen, Germany, 81675
Novartis Investigative Site Completed
Münster, Germany, 48149
Novartis Investigative Site Active, not recruiting
Neuburg an der Donau, Germany, 86633
Novartis Investigative Site Active, not recruiting
Oldenburg, Germany, 26122
Novartis Investigative Site Active, not recruiting
Potsdam, Germany, 14471
Novartis Investigative Site Active, not recruiting
Prien, Germany, 83209
Novartis Investigative Site Completed
Regensburg, Germany, 93053
Novartis Investigative Site Active, not recruiting
Rostock, Germany, 18057
Novartis Investigative Site Completed
Schwendi, Germany, 88477
Novartis Investigative Site Active, not recruiting
Siegen, Germany, 57076
Novartis Investigative Site Active, not recruiting
Stade, Germany, 21682
Novartis Investigative Site Active, not recruiting
Stadtroda, Germany, 07646
Novartis Investigative Site Completed
Teupitz, Germany, 15755
Novartis Investigative Site Terminated
Tuebingen, Germany, D-72076
Novartis Investigative Site Completed
Ulm, Germany, 89073
Novartis Investigative Site Active, not recruiting
Ulm, Germany, 89081
Novartis Investigative Site Active, not recruiting
Unterhaching, Germany, 82008
Novartis Investigative Site Active, not recruiting
Wiesbaden, Germany, 65191
Novartis Investigative Site Active, not recruiting
Würzburg, Germany, 97080
Greece
Novartis Investigative Site Withdrawn
Larissa, GR, Greece, 411 10
Novartis Investigative Site Active, not recruiting
Athens, Greece, 106 76
Novartis Investigative Site Active, not recruiting
Heraklion Crete, Greece, 711 10
Novartis Investigative Site Active, not recruiting
Thessaloniki, Greece, 54636
Hungary
Novartis Investigative Site Active, not recruiting
Budapest, HUN, Hungary, 1204
Novartis Investigative Site Active, not recruiting
Balassagyarmat, Hungary, 2660
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, 1076
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, 1085
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, 1106
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, 1145
Novartis Investigative Site Active, not recruiting
Eger, Hungary, H-3300
Novartis Investigative Site Active, not recruiting
Esztergom, Hungary, 2500
Novartis Investigative Site Withdrawn
Gyor, Hungary, 9024
Novartis Investigative Site Active, not recruiting
Miskolc, Hungary, 3526
Novartis Investigative Site Active, not recruiting
Nyiregyhaza, Hungary, 4400
Novartis Investigative Site Active, not recruiting
Veszprem, Hungary, H-8200
Ireland
Novartis Investigative Site Withdrawn
Wilton, Cork, Ireland
Novartis Investigative Site Active, not recruiting
Dublin 4, Ireland
Novartis Investigative Site Active, not recruiting
Dublin 9, Ireland
Israel
Novartis Investigative Site Active, not recruiting
Jerusalem, Israel, 9112001
Novartis Investigative Site Active, not recruiting
Ramat Gan, Israel, 5266202
Novartis Investigative Site Withdrawn
Tel Aviv, Israel, 6423906
Italy
Novartis Investigative Site Active, not recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20122
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20132
Novartis Investigative Site Active, not recruiting
Cefalù, PA, Italy, 90015
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00133
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00152
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00161
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00168
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00179
Novartis Investigative Site Active, not recruiting
Napoli, Italy, 80131
Japan
Novartis Investigative Site Completed
Chiba-city, Chiba, Japan, 260-8677
Novartis Investigative Site Terminated
Toon-city, Ehime, Japan, 791-0295
Novartis Investigative Site Withdrawn
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site Active, not recruiting
Asahikawa-city, Hokkaido, Japan, 070-8644
Novartis Investigative Site Withdrawn
Sapporo-city, Hokkaido, Japan, 063-0005
Novartis Investigative Site Terminated
Tsukuba-city, Ibaraki, Japan, 305-8576
Novartis Investigative Site Active, not recruiting
Morioka-city, Iwate, Japan, 020-8505
Novartis Investigative Site Active, not recruiting
Kyoto-city, Kyoto, Japan, 604-8453
Novartis Investigative Site Withdrawn
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site Withdrawn
Niigata-city, Niigata, Japan, 951-8520
Novartis Investigative Site Active, not recruiting
Osaka-city, Osaka, Japan, 556-0016
Novartis Investigative Site Active, not recruiting
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site Active, not recruiting
Kawagoe-city, Saitama, Japan, 350-8550
Novartis Investigative Site Completed
Tokorozawa-city, Saitama, Japan, 359-8513
Novartis Investigative Site Completed
Kodaira-city, Tokyo, Japan, 187-8551
Novartis Investigative Site Active, not recruiting
Ota-ku, Tokyo, Japan, 145-0065
Novartis Investigative Site Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Novartis Investigative Site Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Novartis Investigative Site Active, not recruiting
Aomori, Japan, 030-8553
Novartis Investigative Site Withdrawn
Shinjuku-ku, Japan, 160-0023
Latvia
Novartis Investigative Site Active, not recruiting
Riga, LV, Latvia, LV-1005
Novartis Investigative Site Active, not recruiting
Riga, Latvia, 1002
Novartis Investigative Site Active, not recruiting
Riga, Latvia, LV-1038
Lithuania
Novartis Investigative Site Active, not recruiting
Kaunas, LTU, Lithuania, 50009
Novartis Investigative Site Active, not recruiting
Klaipeda, Lithuania, LT-92288
Novartis Investigative Site Active, not recruiting
Vilnius, Lithuania, LT-08661
Netherlands
Novartis Investigative Site Active, not recruiting
Breda, CK, Netherlands, 4818
Novartis Investigative Site Active, not recruiting
Amsterdam, Netherlands, 1105 AZ
Novartis Investigative Site Active, not recruiting
Eindhoven, Netherlands, 5623 EJ
Novartis Investigative Site Active, not recruiting
Hoorn, Netherlands, 1624 NP
Novartis Investigative Site Terminated
Rotterdam, Netherlands, 3079 DZ
Novartis Investigative Site Active, not recruiting
Sittard-Geleen, Netherlands, 6162 BG
Novartis Investigative Site Active, not recruiting
Tilburg, Netherlands, 5022 GC
Poland
Novartis Investigative Site Active, not recruiting
Grudziadz, Poland, 86-300
Novartis Investigative Site Active, not recruiting
Katowice, Poland, 40-595
Novartis Investigative Site Active, not recruiting
Kielce, Poland, 25-726
Novartis Investigative Site Active, not recruiting
Konskie, Poland, 26-200
Novartis Investigative Site Active, not recruiting
Krakow, Poland, 31-637
Novartis Investigative Site Active, not recruiting
Lodz, Poland, 90-324
Novartis Investigative Site Active, not recruiting
Poznan, Poland, 60-355
Novartis Investigative Site Active, not recruiting
Warszawa, Poland, 02-957
Portugal
Novartis Investigative Site Active, not recruiting
Amadora, Portugal, 2720-276
Novartis Investigative Site Active, not recruiting
Braga, Portugal, 4710243
Novartis Investigative Site Active, not recruiting
Coimbra, Portugal, 3000-075
Novartis Investigative Site Completed
Lisboa, Portugal, 1600190
Novartis Investigative Site Active, not recruiting
Porto, Portugal, 4099-001
Romania
Novartis Investigative Site Active, not recruiting
Constanta, Jud. Constanta, Romania, 900591
Novartis Investigative Site Active, not recruiting
Bucharest, Romania, 020125
Novartis Investigative Site Active, not recruiting
Bucharest, Romania, 050098
Novartis Investigative Site Withdrawn
Cluj Napoca, Romania, 400006
Novartis Investigative Site Withdrawn
Craiova, Romania, 200620
Novartis Investigative Site Withdrawn
Iasi, Romania, 700656
Novartis Investigative Site Active, not recruiting
Suceava, Romania, 727525
Novartis Investigative Site Active, not recruiting
Targu Mures, Romania, 540136
Novartis Investigative Site Active, not recruiting
Timisoara, Romania, 300736
Russian Federation
Novartis Investigative Site Active, not recruiting
Barnaul, Russian Federation, 656024
Novartis Investigative Site Active, not recruiting
Kazan, Russian Federation, 420021
Novartis Investigative Site Withdrawn
Kazan, Russian Federation, 420097
Novartis Investigative Site Terminated
Kursk, Russian Federation, 305007
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 119049
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 127018
Novartis Investigative Site Withdrawn
Nizhniy Novgorod, Russian Federation, 603076
Novartis Investigative Site Active, not recruiting
Novosibirsk, Russian Federation, 630007
Novartis Investigative Site Active, not recruiting
Saint-Petersburg, Russian Federation, 194044
Novartis Investigative Site Active, not recruiting
St. Petersburg, Russian Federation, 197110
Novartis Investigative Site Active, not recruiting
St. Petersburg, Russian Federation, 197376
Novartis Investigative Site Active, not recruiting
Ufa, Russian Federation, 450000
Novartis Investigative Site Terminated
Yaroslavl, Russian Federation, 150030
Slovakia
Novartis Investigative Site Completed
Banska Bystrica, Slovakia, 97517
Novartis Investigative Site Completed
Bratislava, Slovakia, 813 69
Novartis Investigative Site Completed
Bratislava, Slovakia, 826 06
Novartis Investigative Site Completed
Martin, Slovakia, 036 59
Novartis Investigative Site Completed
Nitra, Slovakia, 94911
Novartis Investigative Site Completed
Presov, Slovakia, 080 01
Novartis Investigative Site Completed
Trencin, Slovakia, 91171
Novartis Investigative Site Completed
Trnava, Slovakia, 917 75
Spain
Novartis Investigative Site Active, not recruiting
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site Active, not recruiting
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site Active, not recruiting
Barcelona, Cataluna, Spain, 08003
Novartis Investigative Site Active, not recruiting
Barcelona, Cataluna, Spain, 08026
Novartis Investigative Site Active, not recruiting
Badalona, Catalunya, Spain, 08916
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Active, not recruiting
L'Hospitalet de Llobregat, Catalunya, Spain, 08907
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Terminated
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site Active, not recruiting
Majadahonda, Madrid, Spain, 28222
Novartis Investigative Site Active, not recruiting
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Active, not recruiting
Bilbao, Pais Vasco, Spain, 48013
Novartis Investigative Site Active, not recruiting
San Sebastian, Pais Vasco, Spain, 20080
Novartis Investigative Site Completed
Madrid, Spain, 28040
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28040
Sweden
Novartis Investigative Site Active, not recruiting
Goeteborg, Sweden, 413 45
Novartis Investigative Site Active, not recruiting
Stockholm, Sweden, 17176
Novartis Investigative Site Active, not recruiting
Stockholm, Sweden, SE-141 86
Switzerland
Novartis Investigative Site Active, not recruiting
Aarau, CH, Switzerland, 5001
Novartis Investigative Site Active, not recruiting
Basel, Switzerland, 4031
Novartis Investigative Site Active, not recruiting
Lausanne, Switzerland, 1011
Novartis Investigative Site Active, not recruiting
Lugano, Switzerland, 6900
Novartis Investigative Site Active, not recruiting
Luzern, Switzerland, 6000
Novartis Investigative Site Active, not recruiting
St. Gallen, Switzerland, 9007
Novartis Investigative Site Active, not recruiting
Zuerich, Switzerland, 8091
Turkey
Novartis Investigative Site Active, not recruiting
Altunizade, Turkey, 34662
Novartis Investigative Site Active, not recruiting
Atakum / Samsun, Turkey, 55139
Novartis Investigative Site Active, not recruiting
Fatih / Istanbul, Turkey, 34098
Novartis Investigative Site Active, not recruiting
Haseki / Istanbul, Turkey, 34096
Novartis Investigative Site Active, not recruiting
Kocaeli, Turkey, 41380
Novartis Investigative Site Active, not recruiting
Mecidiyekoy/Istanbul, Turkey, 34394
Novartis Investigative Site Active, not recruiting
Trabzon, Turkey, 61080
United Kingdom
Novartis Investigative Site Active, not recruiting
Salford, Manchester, United Kingdom, M6 8HD
Novartis Investigative Site Active, not recruiting
Headington, Oxfordshire, United Kingdom, OX3 9DU
Novartis Investigative Site Active, not recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Novartis Investigative Site Active, not recruiting
Bristol, United Kingdom, BS10 5NB
Novartis Investigative Site Active, not recruiting
Glasgow, United Kingdom, G11 6NT
Novartis Investigative Site Active, not recruiting
Leeds, United Kingdom, LS1 3EX
Novartis Investigative Site Active, not recruiting
Leicester, United Kingdom, LE5 4PW
Novartis Investigative Site Active, not recruiting
London, United Kingdom, EC1A 7BE
Novartis Investigative Site Active, not recruiting
London, United Kingdom, W8 6RF
Novartis Investigative Site Active, not recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01665144     History of Changes
Other Study ID Numbers: CBAF312A2304
Study First Received: August 3, 2012
Last Updated: February 27, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Secondary Progressive Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
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
Neoplastic Processes
Neoplasms

ClinicalTrials.gov processed this record on July 26, 2017