The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)

November 5, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

Study Overview

Status

Completed

Conditions

Multiple Sclerosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2199

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Innsbruck, Austria, A-6020
    - Teva Investigational Site 33013
  - Linz, Austria, 4020
    - Teva Investigational Site 33014
  - Wien, Austria, 1010
    - Teva Investigational Site 33016
  - Wien, Austria, 1090
    - Teva Investigational Site 33015
Belarus
- - Gomel, Belarus, 246029
    - Teva Investigational Site 68010
  - Grodno, Belarus, 230027
    - Teva Investigational Site 68013
  - Minsk, Belarus, 220026
    - Teva Investigational Site 68012
  - Minsk, Belarus, 220114
    - Teva Investigational Site 68009
  - Minsk, Belarus, 220116
    - Teva Investigational Site 68008
  - Vitebsk, Belarus, 210023
    - Teva Investigational Site 68011
Belgium
- - Charleroi, Belgium, 6000
    - Teva Investigational Site 37023
  - Sijsele, Belgium, 8340
    - Teva Investigational Site 37024
Bosnia and Herzegovina
- - Mostar, Bosnia and Herzegovina, 88000
    - Teva Investigational Site 69008
  - Sarajevo, Bosnia and Herzegovina, 71000
    - Teva Investigational Site 69006
  - Tuzla, Bosnia and Herzegovina, 75000
    - Teva Investigational Site 69009
Bulgaria
- - Pleven, Bulgaria, 5800
    - Teva Investigational Site 59039
  - Pleven, Bulgaria, 5800
    - Teva Investigational Site 59040
  - Pleven, Bulgaria, 5800
    - Teva Investigational Site 59060
  - Plovdiv, Bulgaria, 4002
    - Teva Investigational Site 59062
  - Ruse, Bulgaria, 7003
    - Teva Investigational Site 59061
  - Shumen, Bulgaria, 9700
    - Teva Investigational Site 59055
  - Sofia, Bulgaria, 1113
    - Teva Investigational Site 59048
  - Sofia, Bulgaria, 1113
    - Teva Investigational Site 59052
  - Sofia, Bulgaria, 1113
    - Teva Investigational Site 59057
  - Sofia, Bulgaria, 1142
    - Teva Investigational Site 59050
  - Sofia, Bulgaria, 1309
    - Teva Investigational Site 59044
  - Sofia, Bulgaria, 1407
    - Teva Investigational Site 59063
  - Sofia, Bulgaria, 1431
    - Teva Investigational Site 59038
  - Sofia, Bulgaria, 1431
    - Teva Investigational Site 59043
  - Sofia, Bulgaria, 1431
    - Teva Investigational Site 59058
  - Sofia, Bulgaria, 1527
    - Teva Investigational Site 59041
  - Sofia, Bulgaria, 1606
    - Teva Investigational Site 59042
  - Sofia, Bulgaria, 1606
    - Teva Investigational Site 59054
  - Sofia, Bulgaria, 1606
    - Teva Investigational Site 59059
  - Sofia, Bulgaria, 1750
    - Teva Investigational Site 59045
  - Stara Zagora, Bulgaria, 6003
    - Teva Investigational Site 59049
  - Varna, Bulgaria, 9010
    - Teva Investigational Site 59046
  - Veliko Tarnovo, Bulgaria, 5000
    - Teva Investigational Site 59051
  - Veliko Tarnovo, Bulgaria, 5100
    - Teva Investigational Site 59053
Canada
- - Ottawa, Canada, K1H 8L6
    - Teva Investigational Site 11015
  - Saskatoon, Canada, S7K 0M7
    - Teva Investigational Site 11016
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z1
    - Teva Investigational Site 11013
- British Columbia
  - Burnaby, British Columbia, Canada, V5G 2X6
    - Teva Investigational Site 11014
Croatia
- - Osijek, Croatia, 31 000
    - Teva Investigational Site 60010
  - Varazdin, Croatia, 42000
    - Teva Investigational Site 60011
  - Zagreb, Croatia, 10000
    - Teva Investigational Site 60009
Czechia
- - Brno, Czechia, 602 00
    - Teva Investigational Site 54042
  - Havirov, Czechia, 736 01
    - Teva Investigational Site 54043
  - Hradec Kralove 3, Czechia, 50003
    - Teva Investigational Site 54047
  - Jihlava, Czechia, 58633
    - Teva Investigational Site 54046
  - Olomouc, Czechia, 779 00
    - Teva Investigational Site 54044
  - Ostrava, Czechia, 702 00
    - Teva Investigational Site 54045
  - Praha, Czechia, 104 00
    - Teva Investigational Site 54041
  - Praha 10, Czechia, 100 31
    - Teva Investigational Site 54049
  - Teplice, Czechia, 415 29
    - Teva Investigational Site 54048
Estonia
- - Parnu, Estonia, 80010
    - Teva Investigational Site 55005
  - Tallinn, Estonia, EE-10138
    - Teva Investigational Site 55008
  - Tallinn, Estonia, EE-10617
    - Teva Investigational Site 55006
  - Tartu, Estonia, EE-51014
    - Teva Investigational Site 55007
France
- - Clermont-Ferrand Cedex 1, France, 63003
    - Teva Investigational Site 35075
  - Dijon, France
    - Teva Investigational Site 35077
  - Lille, France, 59000
    - Teva Investigational Site 35073
  - Lyon cedex 04, France, 69317
    - Teva Investigational Site 35076
  - Nimes, France, 30029
    - Teva Investigational Site 35079
Georgia
- - Tbilisi, Georgia, 0112
    - Teva Investigational Site 81018
  - Tbilisi, Georgia, 0141
    - Teva Investigational Site 81014
  - Tbilisi, Georgia, 0179
    - Teva Investigational Site 81015
  - Tbilisi, Georgia, 0179
    - Teva Investigational Site 81019
  - Tbilisi, Georgia, 0186
    - Teva Investigational Site 81017
  - Tbilisi, Georgia, 0194
    - Teva Investigational Site 81016
Germany
- - Bad Mergentheim, Germany, 97980
    - Teva Investigational Site 32199
  - Berg, Germany, 82335
    - Teva Investigational Site 32195
  - Berlin, Germany, 10117
    - Teva Investigational Site 32200
  - Berlin, Germany, 10437
    - Teva Investigational Site 32186
  - Berlin, Germany, 10625
    - Teva Investigational Site 32176
  - Berlin, Germany, 10713
    - Teva Investigational Site 32174
  - Berlin, Germany, 12163
    - Teva Investigational Site 32198
  - Bochum, Germany, 44791
    - Teva Investigational Site 32177
  - Dresden, Germany, 01307
    - Teva Investigational Site 32193
  - Erbach, Germany, 64711
    - Teva Investigational Site 32184
  - Erfurt, Germany, 99089
    - Teva Investigational Site 32189
  - Giessen, Germany, 35385
    - Teva Investigational Site 32203
  - Goettigen, Germany, 37075
    - Teva Investigational Site 32202
  - Halle (Saale), Germany, 06120
    - Teva Investigational Site 32196
  - Hamburg, Germany, 20246
    - Teva Investigational Site 32181
  - Hamburg, Germany, 22083
    - Teva Investigational Site 32179
  - Hannover, Germany, 30171
    - Teva Investigational Site 32182
  - Ibbenburen, Germany, 49477
    - Teva Investigational Site 32175
  - Jena, Germany, 07743
    - Teva Investigational Site 32201
  - Koln, Germany, 50935
    - Teva Investigational Site 32183
  - Leipzig, Germany, 4103
    - Teva Investigational Site 32190
  - Magdeburg, Germany, 39120
    - Teva Investigational Site 32185
  - Rostock, Germany, 18147
    - Teva Investigational Site 32191
  - Teupitz, Germany, 15755
    - Teva Investigational Site 32194
  - Ulm, Germany, 89081
    - Teva Investigational Site 32173
  - Wermsdorf, Germany, 04773
    - Teva Investigational Site 32197
  - Westerstede, Germany, 26655
    - Teva Investigational Site 32188
Greece
- - Athens, Greece, 115 28
    - Teva Investigational Site 63027
  - Athens, Greece, 11525
    - Teva Investigational Site 63024
  - Chaidari, Greece, 12462
    - Teva Investigational Site 63029
  - Heraklion, Greece, 71110
    - Teva Investigational Site 63026
  - Larisa, Greece, 41110
    - Teva Investigational Site 63030
  - Thessaloniki, Greece, 54636
    - Teva Investigational Site 63025
  - Thessaloniki, Greece, 57010
    - Teva Investigational Site 63028
Hungary
- - Budapest, Hungary, 1134
    - Teva Investigational Site 51046
  - Debrecen, Hungary, 4043
    - Teva Investigational Site 51043
  - Eger, Hungary, H-3300
    - Teva Investigational Site 51045
  - Kaposvar, Hungary, H-7400
    - Teva Investigational Site 51044
Israel
- - Haifa, Israel, 31096
    - Teva Investigational Site 80023
  - Haifa, Israel, 31096
    - Teva Investigational Site 80024
  - Ramat Gan, Israel, 5262160
    - Teva Investigational Site 80020
  - Tel Aviv, Israel, 64239
    - Teva Investigational Site 80021
Italy
- - Bologna, Italy, 40139
    - Teva Investigational Site 30037
  - Castelfiorentino, Italy, 50051
    - Teva Investigational Site 30031
  - Cefalu, Italy, 90015
    - Teva Investigational Site 30030
  - Chieti, Italy, 66100
    - Teva Investigational Site 30032
  - Firenze, Italy, 50139
    - Teva Investigational Site 30024
  - Gallarate, Italy, 21013
    - Teva Investigational Site 30029
  - Milano, Italy, 20132
    - Teva Investigational Site 30023
  - Milano, Italy, 20133
    - Teva Investigational Site 30039
  - Napoli, Italy, 80131
    - Teva Investigational Site 30034
  - Palermo, Italy, 90146
    - Teva Investigational Site 30027
  - Rome, Italy, 00149
    - Teva Investigational Site 30028
  - Rome, Italy, 00163
    - Teva Investigational Site 30025
  - Rome, Italy, 00168
    - Teva Investigational Site 30026
  - Rome, Italy, 00178
    - Teva Investigational Site 30035
  - Verona, Italy, 37134
    - Teva Investigational Site 30040
Korea, Republic of
- - Goyang-si, Korea, Republic of, 410-769
    - Teva Investigational Site 87001
  - Seoul, Korea, Republic of, 03080
    - Teva Investigational Site 87003
  - Seoul, Korea, Republic of, 138-736
    - Teva Investigational Site 87002
Latvia
- - Riga, Latvia, 1038
    - Teva Investigational Site 56006
  - Riga, Latvia, LV-1005
    - Teva Investigational Site 56005
Moldova, Republic of
- - Chisinau, Moldova, Republic of, 2001
    - Teva Investigational Site 70006
  - Chisinau, Moldova, Republic of, 2024
    - Teva Investigational Site 70005
  - Chisinau, Moldova, Republic of, 2028
    - Teva Investigational Site 70008
Montenegro
- - Podgorica, Montenegro, 20000
    - Teva Investigational Site 66002
North Macedonia
- - Skopje, North Macedonia, 1000
    - Teva Investigational Site 65010
  - Skopje, North Macedonia, 1000
    - Teva Investigational Site 65011
  - Skopje, North Macedonia, 1000
    - Teva Investigational Site 65012
Poland
- - Bialystok, Poland, 15-276
    - Teva Investigational Site 53066
  - Bialystok, Poland, 15-402
    - Teva Investigational Site 53071
  - Bydgoszcz, Poland, 85-654
    - Teva Investigational Site 53085
  - Czestochowa, Poland, 42-280
    - Teva Investigational Site 53084
  - Gdansk, Poland, 80-299
    - Teva Investigational Site 53069
  - Gdansk, Poland, 80-546
    - Teva Investigational Site 53083
  - Gdansk, Poland, 80-803
    - Teva Investigational Site 53067
  - Grodzisk Mazowiecki, Poland, 05-825
    - Teva Investigational Site 53078
  - Katowice, Poland, 40-555
    - Teva Investigational Site 53080
  - Katowice, Poland, 40-650
    - Teva Investigational Site 53081
  - Katowice, Poland, 40-684
    - Teva Investigational Site 53073
  - Katowice, Poland, 40-749
    - Teva Investigational Site 53070
  - Katowice, Poland, 40-752
    - Teva Investigational Site 53074
  - Konskie, Poland, 26-200
    - Teva Investigational Site 53064
  - Konstancin-Jeziorna, Poland, 05-510
    - Teva Investigational Site 53065
  - Koscierzyna, Poland, 83-400
    - Teva Investigational Site 53072
  - Lodz, Poland, 90-324
    - Teva Investigational Site 53063
  - Olsztyn, Poland, 10-560
    - Teva Investigational Site 53079
  - Plewiska, Poland, 62-064
    - Teva Investigational Site 53068
  - Szczecin, Poland, 70-111
    - Teva Investigational Site 53076
Romania
- - Balotesti, Romania, 77015
    - Teva Investigational Site 52045
  - Bucharest, Romania, 012071
    - Teva Investigational Site 52041
  - Bucuresti, Romania, 020125
    - Teva Investigational Site 52050
  - Bucuresti, Romania, 022328
    - Teva Investigational Site 52037
  - Bucuresti, Romania, 050098
    - Teva Investigational Site 52034
  - Cluj-Napoca, Romania, 400006
    - Teva Investigational Site 52040
  - Cluj-Napoca, Romania, 400437
    - Teva Investigational Site 52036
  - Constanta, Romania, 900123
    - Teva Investigational Site 52038
  - Constanta, Romania, 900591
    - Teva Investigational Site 52044
  - Craiova, Romania, 200473
    - Teva Investigational Site 52048
  - Hunedoara, Romania, 331057
    - Teva Investigational Site 52049
  - Iasi, Romania, 700661
    - Teva Investigational Site 52042
  - Oradea, Romania, 410108
    - Teva Investigational Site 52039
  - Piatra-Neamt, Romania, 610136
    - Teva Investigational Site 52047
  - Sibiu, Romania, 550245
    - Teva Investigational Site 52046
  - Targu Mures, Romania
    - Teva Investigational Site 52035
  - Timisoara, Romania, 100182
    - Teva Investigational Site 52043
Russian Federation
- - Barnaul, Russian Federation, 656024
    - Teva Investigational Site 50130
  - Chelyabinsk, Russian Federation, 454021
    - Teva Investigational Site 50129
  - Kazan, Russian Federation, 420021
    - Teva Investigational Site 50208
  - Kemerovo, Russian Federation, 650061
    - Teva Investigational Site 50148
  - Krasnodar, Russian Federation, 350012
    - Teva Investigational Site 50144
  - Moscow, Russian Federation, 119021
    - Teva Investigational Site 50147
  - Moscow, Russian Federation, 127015
    - Teva Investigational Site 50124
  - Moscow, Russian Federation, 129110
    - Teva Investigational Site 50133
  - Moscow, Russian Federation, 129128
    - Teva Investigational Site 50146
  - Nizhny Novgorod, Russian Federation, 603076
    - Teva Investigational Site 50141
  - Nizhny Novgorod, Russian Federation, 603155
    - Teva Investigational Site 50128
  - Nizhny Novgorod, Russian Federation, 603155
    - Teva Investigational Site 50131
  - Perm, Russian Federation, 614990
    - Teva Investigational Site 50127
  - Rostov-on-Don, Russian Federation, 344015
    - Teva Investigational Site 50143
  - Rostov-on-Don, Russian Federation, 344022
    - Teva Investigational Site 50149
  - Saint Petersburg, Russian Federation, 191186
    - Teva Investigational Site 50126
  - Saint Petersburg, Russian Federation, 197022
    - Teva Investigational Site 50140
  - Samara, Russian Federation, 443095
    - Teva Investigational Site 50138
  - Saratov, Russian Federation, 410054
    - Teva Investigational Site 50135
  - Smolensk, Russian Federation, 214018
    - Teva Investigational Site 50136
  - St. Petersburg, Russian Federation, 194354
    - Teva Investigational Site 50137
  - Tomsk, Russian Federation, 634050
    - Teva Investigational Site 50125
  - Tyumen, Russian Federation, 625000
    - Teva Investigational Site 50139
  - Ufa, Russian Federation, 450007
    - Teva Investigational Site 50134
  - Volgograd, Russian Federation, 400138
    - Teva Investigational Site 50132
  - Yaroslavl, Russian Federation, 150030
    - Teva Investigational Site 50142
Serbia
- - Belgrade, Serbia, 11000
    - Teva Investigational Site 61025
  - Belgrade, Serbia, 11000
    - Teva Investigational Site 61027
  - Belgrade, Serbia, 11080
    - Teva Investigational Site 61024
  - Cacak, Serbia, 32000
    - Teva Investigational Site 61018
  - Kragujevac, Serbia, 34000
    - Teva Investigational Site 61015
  - Nis, Serbia, 18000
    - Teva Investigational Site 61014
  - Sombor, Serbia, 25000
    - Teva Investigational Site 61019
  - Subotica, Serbia, 24000
    - Teva Investigational Site 61016
  - Uzice, Serbia, 31000
    - Teva Investigational Site 61017
  - Valjevo, Serbia, 14000
    - Teva Investigational Site 61022
  - Vrbas, Serbia, 21460
    - Teva Investigational Site 61026
  - Zrenjanin, Serbia, 23000
    - Teva Investigational Site 61021
Slovakia
- - Hlohovec, Slovakia, 92001
    - Teva Investigational Site 62012
  - Trnava, Slovakia, 917 75
    - Teva Investigational Site 62013
Spain
- - Barcelona, Spain, 08025
    - Teva Investigational Site 31035
  - Barcelona, Spain, 08035
    - Teva Investigational Site 31030
  - Getafe, Spain, 28905
    - Teva Investigational Site 31031
  - L'Hospitalet de Llobregat, Spain, 08907
    - Teva Investigational Site 31036
  - Madrid, Spain, 28040
    - Teva Investigational Site 31032
  - Madrid, Spain, 28046
    - Teva Investigational Site 31034
  - Navarro, Spain, 31008
    - Teva Investigational Site 31033
  - Oviedo, Spain, 33011
    - Teva Investigational Site 31039
  - Salt, Spain, 17190
    - Teva Investigational Site 31037
Ukraine
- - Chernihiv, Ukraine, 14001
    - Teva Investigational Site 58087
  - Chernivtsi, Ukraine, 58018
    - Teva Investigational Site 58083
  - Dnipropetrovsk, Ukraine, 49044
    - Teva Investigational Site 58077
  - Ivano-Frankivsk, Ukraine, 76008
    - Teva Investigational Site 58088
  - Ivano-Frankivsk, Ukraine
    - Teva Investigational Site 58076
  - Kharkiv, Ukraine, 61068
    - Teva Investigational Site 58116
  - Kharkiv, Ukraine, 61103
    - Teva Investigational Site 58084
  - Kiev, Ukraine, 04112
    - Teva Investigational Site 58089
  - Kyiv, Ukraine, 01601
    - Teva Investigational Site 58073
  - Kyiv, Ukraine, 03110
    - Teva Investigational Site 58078
  - Kyiv, Ukraine, 03115
    - Teva Investigational Site 58081
  - Lviv, Ukraine, 79013
    - Teva Investigational Site 58115
  - Lviv, Ukraine, 79059
    - Teva Investigational Site 58086
  - Odesa, Ukraine, 65025
    - Teva Investigational Site 58074
  - Odessa, Ukraine, 65014
    - Teva Investigational Site 58085
  - Poltava, Ukraine, 36024
    - Teva Investigational Site 58082
  - Simferopol, Ukraine, 95000
    - Teva Investigational Site 58080
  - Vinnytsya, Ukraine, 21005
    - Teva Investigational Site 58072
  - Zaporizhzhya, Ukraine, 69035
    - Teva Investigational Site 58079
  - Zaporizhzhya, Ukraine, 69600
    - Teva Investigational Site 58075
United Kingdom
- - Glasgow, United Kingdom, G51 4TF
    - Teva Investigational Site 34015
  - Liverpool, United Kingdom, B0T 1K0
    - Teva Investigational Site 34011
  - Liverpool, United Kingdom, L9 7LJ
    - Teva Investigational Site 34010
  - London, United Kingdom, E1 1BB
    - Teva Investigational Site 34019
  - Salford, United Kingdom, M6 8HD
    - Teva Investigational Site 34016
  - Sheffield, United Kingdom, S10 2JF
    - Teva Investigational Site 34017
  - Stoke-on-Trent, United Kingdom, ST4 6QG
    - Teva Investigational Site 34013
United States
- Alabama
  - Cullman, Alabama, United States, 35058
    - Teva Investigational Site 10329
- Arizona
  - Sun City, Arizona, United States, 85351
    - Teva Investigational Site 10349
  - Tucson, Arizona, United States, 85741-3537
    - Teva Investigational Site 10342
- California
  - Fresno, California, United States, 93710
    - Teva Investigational Site 10310
- Colorado
  - Aurora, Colorado, United States, 80045
    - Teva Investigational Site 10307
  - Centennial, Colorado, United States, 80112
    - Teva Investigational Site 10334
  - Fort Collins, Colorado, United States, 80528
    - Teva Investigational Site 10332
- Florida
  - Coral Gables, Florida, United States, 33146
    - Teva Investigational Site 10316
  - Saint Petersburg, Florida, United States, 33701
    - Teva Investigational Site 10341
  - Sarasota, Florida, United States, 34233
    - Teva Investigational Site 10308
  - Sunrise, Florida, United States, 33351
    - Teva Investigational Site 10315
  - Tampa, Florida, United States, 33606
    - Teva Investigational Site 10323
- Illinois
  - Chicago, Illinois, United States, 60612
    - Teva Investigational Site 10350
  - Evanston, Illinois, United States, 60201
    - Teva Investigational Site 10345
  - Northbrook, Illinois, United States, 60062
    - Teva Investigational Site 10343
- Indiana
  - Fort Wayne, Indiana, United States, 46805
    - Teva Investigational Site 10339
- Kansas
  - Lenexa, Kansas, United States, 66214
    - Teva Investigational Site 10348
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Teva Investigational Site 10338
- North Carolina
  - Advance, North Carolina, United States, 27006
    - Teva Investigational Site 10346
  - Winston-Salem, North Carolina, United States, 27157
    - Teva Investigational Site 10347
- Ohio
  - Bellevue, Ohio, United States, 44811
    - Teva Investigational Site 10309
  - Columbus, Ohio, United States, 43221
    - Teva Investigational Site 10317
  - Dayton, Ohio, United States, 45417
    - Teva Investigational Site 10325
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033-0850
    - Teva Investigational Site 10340
  - Philadelphia, Pennsylvania, United States, 19104
    - Teva Investigational Site 10331
- Tennessee
  - Cordova, Tennessee, United States, 38018
    - Teva Investigational Site 10313
  - Franklin, Tennessee, United States, 37064
    - Teva Investigational Site 10324
  - Nashville, Tennessee, United States, 37205
    - Teva Investigational Site 10318
- Utah
  - Salt Lake City, Utah, United States, 84103
    - Teva Investigational Site 10319
- Virginia
  - Newport News, Virginia, United States, 23601
    - Teva Investigational Site 10330
  - Roanoke, Virginia, United States, 24018
    - Teva Investigational Site 10311
- Washington
  - Seattle, Washington, United States, 98122
    - Teva Investigational Site 10335

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
Participants must be ambulatory with Kurtzke's expanded disability status scale (EDSS) score of 0 to 5.5 in both screening and randomization visits.
Participants must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)/oral] or adrenocorticotrophic hormone, 60 days prior to randomization.
Participants must have experienced at least one documented relapse in the 12 months prior to randomization.
Participants must have disease duration of not more than 15 years.
Women of child-bearing potential (for example, women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication.
- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

Participants with progressive forms of MS.
Participants with neuromyelitis optica.
Use of experimental or investigational drugs and/or participation in drug clinical studies within the 6 months prior to randomization.
Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide, within 6 months prior to randomization.
Use of either of the following within 2 years prior to randomization visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization.
Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulins within 2 months prior to randomization.
Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.
Previous use of mitoxantrone (Novantrone®), cladribine, or alemtuzumab (Lemtrada®).
Previous use of laquinimod.
Previous total body irradiation or total lymphoid irradiation.
Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to randomization.
Use of inducers of CYP3A4 within 2 weeks prior to randomization visit.
Pregnancy or breastfeeding.
A known history of sensitivity to gadolinium (Gd).
Inability to successfully undergo magnetic resonance imaging (MRI) scanning.
Participants who underwent endovascular treatment for chronic cerebrospinal venous insufficiency within 3 months prior to randomization.
- Additional criteria apply, please contact the investigator for more information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo-Controlled Phase: Placebo Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.	Drug: Placebo Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.
EXPERIMENTAL: Placebo-Controlled Phase: Laquinimod 0.6 mg Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.	Drug: Placebo Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms. Drug: Laquinimod Laquinimod will be administered as per the dose and schedule specified in the respective arms.
EXPERIMENTAL: Placebo-Controlled Phase: Laquinimod 1.2 mg Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.	Drug: Laquinimod Laquinimod will be administered as per the dose and schedule specified in the respective arms.
EXPERIMENTAL: Active Treatment Phase: Laquinimod 0.6 mg Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.	Drug: Placebo Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms. Drug: Laquinimod Laquinimod will be administered as per the dose and schedule specified in the respective arms.
EXPERIMENTAL: Active Treatment Phase: Laquinimod 1.2 mg Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.	Drug: Laquinimod Laquinimod will be administered as per the dose and schedule specified in the respective arms.
NO_INTERVENTION: Active Treatment Phase: Off Drug Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 will continue the active-treatment phase off drug for 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) Time Frame: Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.	Baseline to Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 Time Frame: Baseline, Month 15	Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.	Baseline, Month 15
Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) Time Frame: Baseline to Month 24	Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).	Baseline to Month 24
Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months) Time Frame: Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.	Baseline to Month 24
Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months) Time Frame: Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.	Baseline to Month 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs) Time Frame: Baseline up to Month 24	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.	Baseline up to Month 24
Active-Treatment Phase: Number of Participants With AEs Time Frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities Time Frame: Baseline up to Week 24	Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (>=) 120 beats per minute (bpm) and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 millimeters of mercury (mmHg) and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.	Baseline up to Week 24
Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities Time Frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	Clinically significant vital signs abnormalities included: Pulse rate: >=120 bpm and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 mmHg and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters Time Frame: Baseline, Endpoint (Month 24)	ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.	Baseline, Endpoint (Month 24)
Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters Time Frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)	ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)
Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Time Frame: Baseline up to Month 24	Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter [U/L]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter [mg/L]), pancreatic amylase (in U/L)>=3 * upper limit of normal (ULN); Fibrinogen >=6 grams per liter (gm/L); Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L.	Baseline up to Month 24
Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Time Frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)>=3 * ULN; Fibrinogen >=6 gm/L; Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin >=28 micromols per liter (micromols/L); Creatinine >=117 micromols/L; Albumin <=25 gm/L.	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values Time Frame: Baseline up to Month 24	Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5 grams per deciliter (gm/dL) in males and <=10 gm/dL in females; White blood cells (WBCs) count <=2.5 and >=2110^9 per liter (L); Absolute neutrophil count (ANC) <=1.4910^9 per L; Platelet count <=100 and >=600*10^9 per L.	Baseline up to Month 24
Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values Time Frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5, >=20 gm/dL in males, and <=10, >=18.5 gm/dL in females; WBCs count <=2.5 and >=2110^9 per L; ANC <=1.4910^9 per L; Platelet count <=100 and >=600*10^9 per L.	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Comi G, Dadon Y, Sasson N, Steinerman JR, Knappertz V, Vollmer TL, Boyko A, Vermersch P, Ziemssen T, Montalban X, Lublin FD, Rocca MA, Volkinshtein R, Rubinchick S, Halevy N, Filippi M. CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. Mult Scler. 2022 Apr;28(4):608-619. doi: 10.1177/13524585211032803. Epub 2021 Aug 11.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 20, 2013

Primary Completion (ACTUAL)

April 13, 2015

Study Completion (ACTUAL)

July 4, 2017

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (ESTIMATE)

October 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LAQ-MS-305
2012-003647-30 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Multiple Sclerosis

Clinical Trials on Placebo

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