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

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ClinicalTrials.gov Identifier: NCT01707992
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
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 subjects with RRMS. . The study has periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Laquinimod Drug: Matching Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Actual Study Start Date : February 20, 2013
Actual Primary Completion Date : April 13, 2015
Actual Study Completion Date : July 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laquinimod Dose 0.6 mg
Two capsules, one containing 0.6 mg laquinimod and the other containing matching placebo, to be administered orally once daily during both Periods 1 and 2.
Drug: Laquinimod
Experimental: Laquinimod Dose 1.2 mg

Two capsules containing 0.6 mg laquinimod to be administered orally once daily during both Periods 1 and 2.

NOTE- As of January 2016, this arm has been discontinued.

Drug: Laquinimod
Placebo Comparator: Placebo
Two capsules containing placebo (matching to the 0.6 mg) to be administered orally once daily during Period 1.
Drug: Matching Placebo



Primary Outcome Measures :
  1. Time to Confirmed Disease Progression (CDP) after at least 3 months in Period 1 [ Time Frame: 24 months (Period 1) ]
    CDP is defined as an increase in Expanded Disability Status Scale (EDSS)


Secondary Outcome Measures :
  1. Percent change in brain volume [ Time Frame: Change from Baseline to 15 Months ]
    This is a measure of brain volume and will be assessed by an MRI. Brain atrophy is defined as the percent change in brain volume from baseline to month 15

  2. The time to first confirmed relapse during Period 1 [ Time Frame: 24 months (Period 1) ]
  3. Time to CDP confirmed after at least 6 months [ Time Frame: 24 months (Period 1) ]
  4. Time to CDP confirmed after at least 9 months [ Time Frame: 24 months (Period 1) ]

Other Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: 24 months (Period 1) ]
  2. Number of Participants with Abnormal Vital Signs [ Time Frame: 24 months (Period 1) ]
  3. Number of Participants with Abnormal ECG Findings [ Time Frame: 24 months (Period 1) ]
  4. Number of Participants with Abnormal Clinical Laboratory Parameters [ Time Frame: 24 months (Period 1) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
  • Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
  • Subjects must have experienced at least one documented relapse in the 12 months prior to randomization.
  • Subjects 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 o Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Subjects with progressive forms of MS.
  • Subjects with Neuromyelitis Optica (NMO).
  • Use of experimental or investigational drugs and/or participation in drug clinical studies within 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 screening 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 immunoglobulin (IVIG) 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 stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  • Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to randomization.
  • Use of inducers of CYP3A4 within 2 weeks prior to randomization.
  • Pregnancy or breastfeeding.
  • A known history of sensitivity to gadolinium (Gd).
  • Inability to successfully undergo MRI scanning.
  • Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) within 3 months prior to randomization.

    • Additional criteria apply, please contact the investigator for more information

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): NCT01707992


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Locations
United States, Alabama
Teva Investigational Site 10329
Cullman, Alabama, United States, 35058
United States, California
Teva Investigational Site 10310
Fresno, California, United States, 93710
United States, Colorado
Teva Investigational Site 10332
Fort Collins, Colorado, United States, 80528
United States, Florida
Teva Investigational Site 10316
Coral Gables, Florida, United States, 33146
Teva Investigational Site 10308
Sarasota, Florida, United States, 34233
United States, Indiana
Teva Investigational Site 10339
Fort Wayne, Indiana, United States, 46805
United States, Massachusetts
Teva Investigational Site 10338
Boston, Massachusetts, United States, 02215
United States, North Carolina
Teva Investigational Site 10347
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Teva Investigational Site 10309
Bellevue, Ohio, United States, 44811
Teva Investigational Site 10325
Dayton, Ohio, United States, 45417
United States, Tennessee
Teva Investigational Site 10324
Franklin, Tennessee, United States, 37064
United States, Virginia
Teva Investigational Site 10330
Newport News, Virginia, United States, 23601
Teva Investigational Site 10311
Roanoke, Virginia, United States, 24018
United States, Washington
Teva Investigational Site 10335
Seattle, Washington, United States, 98122
Austria
Teva Investigational Site 33014
Linz, Austria, 4020
Teva Investigational Site 33016
Wien, Austria, 1010
Teva Investigational Site 33015
Wien, Austria, 1090
Belarus
Teva Investigational Site 68013
Grodno, Belarus, 230027
Teva Investigational Site 68012
Minsk, Belarus, 220026
Teva Investigational Site 68009
Minsk, Belarus, 220114
Teva Investigational Site 68008
Minsk, Belarus, 220116
Teva Investigational Site 68011
Vitebsk, Belarus, 210023
Bosnia and Herzegovina
Teva Investigational Site 69008
Mostar, Bosnia and Herzegovina, 88000
Teva Investigational Site 69006
Sarajevo, Bosnia and Herzegovina, 71000
Teva Investigational Site 69009
Tuzla, Bosnia and Herzegovina, 75000
Bulgaria
Teva Investigational Site 59039
Pleven, Bulgaria, 5800
Teva Investigational Site 59040
Pleven, Bulgaria, 5800
Teva Investigational Site 59060
Pleven, Bulgaria, 5800
Teva Investigational Site 59061
Ruse, Bulgaria, 7003
Teva Investigational Site 59055
Shumen, Bulgaria, 9700
Teva Investigational Site 59048
Sofia, Bulgaria, 1113
Teva Investigational Site 59052
Sofia, Bulgaria, 1113
Teva Investigational Site 59057
Sofia, Bulgaria, 1113
Teva Investigational Site 59050
Sofia, Bulgaria, 1142
Teva Investigational Site 59044
Sofia, Bulgaria, 1309
Teva Investigational Site 59063
Sofia, Bulgaria, 1407
Teva Investigational Site 59038
Sofia, Bulgaria, 1431
Teva Investigational Site 59043
Sofia, Bulgaria, 1431
Teva Investigational Site 59058
Sofia, Bulgaria, 1431
Teva Investigational Site 59041
Sofia, Bulgaria, 1527
Teva Investigational Site 59042
Sofia, Bulgaria, 1606
Teva Investigational Site 59054
Sofia, Bulgaria, 1606
Teva Investigational Site 59059
Sofia, Bulgaria, 1606
Teva Investigational Site 59045
Sofia, Bulgaria, 1750
Teva Investigational Site 59046
Varna, Bulgaria, 9010
Teva Investigational Site 59051
Veliko Tarnovo, Bulgaria, 5000
Teva Investigational Site 59053
Veliko Tarnovo, Bulgaria, 5100
Canada
Teva Investigational Site 11016
Saskatoon, Canada, S7K 0M7
Croatia
Teva Investigational Site 60010
Osijek, Croatia, 31 000
Teva Investigational Site 60011
Varazdin, Croatia, 42000
Teva Investigational Site 60009
Zagreb, Croatia, 10000
Czechia
Teva Investigational Site 54042
Brno, Czechia, 602 00
Teva Investigational Site 54043
Havirov, Czechia, 736 01
Teva Investigational Site 54047
Hradec Kralove 3, Czechia, 50003
Teva Investigational Site 54046
Jihlava, Czechia, 58633
Teva Investigational Site 54044
Olomouc, Czechia, 779 00
Teva Investigational Site 54048
Teplice, Czechia, 415 29
Estonia
Teva Investigational Site 55005
Paernu, Estonia, 80010
Teva Investigational Site 55008
Tallinn, Estonia, EE-10138
Teva Investigational Site 55006
Tallinn, Estonia, EE-10617
Teva Investigational Site 55007
Tartu, Estonia, EE-51014
France
Teva Investigational Site 35075
Clermont-Ferrand Cedex 1, France, 63003
Teva Investigational Site 35077
Dijon, France
Teva Investigational Site 35073
Lille, France, 59000
Teva Investigational Site 35079
Nimes, France, 30029
Georgia
Teva Investigational Site 81018
Tbilisi, Georgia, 0112
Teva Investigational Site 81014
Tbilisi, Georgia, 0141
Teva Investigational Site 81015
Tbilisi, Georgia, 0179
Teva Investigational Site 81019
Tbilisi, Georgia, 0179
Teva Investigational Site 81017
Tbilisi, Georgia, 0186
Teva Investigational Site 81016
Tbilisi, Georgia, 0194
Germany
Teva Investigational Site 32186
Berlin, Germany, 10437
Teva Investigational Site 32198
Berlin, Germany, 12163
Teva Investigational Site 32193
Dresden, Germany, 01307
Teva Investigational Site 32201
Jena, Germany, 07743
Teva Investigational Site 32183
Koln, Germany, 50935
Teva Investigational Site 32190
Leipzig, Germany, 4103
Teva Investigational Site 32185
Magdeburg, Germany, 39120
Teva Investigational Site 32173
Ulm, Germany, 89081
Teva Investigational Site 32188
Westerstede, Germany, 26655
Greece
Teva Investigational Site 63027
Athens, Greece, 115 28
Teva Investigational Site 63024
Athens, Greece, 11525
Teva Investigational Site 63025
Thessaloniki, Greece, 54636
Teva Investigational Site 63028
Thessaloniki, Greece, 57010
Hungary
Teva Investigational Site 51043
Debrecen, Hungary, 4043
Teva Investigational Site 51044
Kaposvar, Hungary, H-7400
Israel
Teva Investigational Site 80023
Haifa, Israel, 31096
Teva Investigational Site 80024
Haifa, Israel, 31096
Teva Investigational Site 80020
Ramat Gan, Israel, 5262160
Teva Investigational Site 80021
Tel Aviv, Israel, 64239
Italy
Teva Investigational Site 30037
Bologna, Italy, 40139
Teva Investigational Site 30031
Castelfiorentino, Italy, 50051
Teva Investigational Site 30030
Cefalu, Italy, 90015
Teva Investigational Site 30032
Chieti, Italy, 66100
Teva Investigational Site 30023
Milano, Italy, 20132
Teva Investigational Site 30034
Napoli, Italy, 80131
Teva Investigational Site 30028
Rome, Italy, 00149
Teva Investigational Site 30025
Rome, Italy, 00163
Teva Investigational Site 30026
Rome, Italy, 00168
Teva Investigational Site 30035
Rome, Italy, 00178
Korea, Republic of
Teva Investigational Site 87001
Goyang-si Gyeonggi-do Korea, Korea, Republic of, 410-769
Teva Investigational Site 87002
Seoul, Korea, Republic of, 138-736
Latvia
Teva Investigational Site 56006
Riga, Latvia, 1038
Teva Investigational Site 56005
Riga, Latvia, LV-1005
Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65010
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Teva Investigational Site 65011
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Teva Investigational Site 65012
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Moldova, Republic of
Teva Investigational Site 70006
Chisinau, Moldova, Republic of, 2001
Teva Investigational Site 70005
Chisinau, Moldova, Republic of, 2024
Teva Investigational Site 70008
Chisinau, Moldova, Republic of, 2028
Montenegro
Teva Investigational Site 66002
Podgorica, Montenegro, 20000
Poland
Teva Investigational Site 53071
Bialystok, Poland, 15-402
Teva Investigational Site 53085
Bydgoszcz, Poland, 85-654
Teva Investigational Site 53084
Czestochowa, Poland, 42-280
Teva Investigational Site 53069
Gdansk, Poland, 80-299
Teva Investigational Site 53067
Gdansk, Poland, 80-803
Teva Investigational Site 53078
Grodzisk Mazowiecki, Poland, 05-825
Teva Investigational Site 53080
Katowice, Poland, 40-555
Teva Investigational Site 53073
Katowice, Poland, 40-684
Teva Investigational Site 53070
Katowice, Poland, 40-749
Teva Investigational Site 53074
Katowice, Poland, 40-752
Teva Investigational Site 53064
Konskie, Poland, 26-200
Teva Investigational Site 53065
Konstancin-Jeziorna, Poland, 05-510
Teva Investigational Site 53072
Koscierzyna, Poland, 83-400
Teva Investigational Site 53068
Poznan / Plewiska, Poland, 62-064
Teva Investigational Site 53076
Szczecin, Poland, 70-111
Romania
Teva Investigational Site 52045
Balotesti, Romania, 77015
Teva Investigational Site 52041
Bucharest, Romania, 012071
Teva Investigational Site 52050
Bucuresti, Romania, 020125
Teva Investigational Site 52037
Bucuresti, Romania, 022328
Teva Investigational Site 52034
Bucuresti, Romania, 050098
Teva Investigational Site 52040
Cluj-Napoca, Romania, 400006
Teva Investigational Site 52036
Cluj-Napoca, Romania, 400437
Teva Investigational Site 52038
Constanta, Romania, 900123
Teva Investigational Site 52044
Constanta, Romania, 900591
Teva Investigational Site 52048
Dolj, Romania, 200473
Teva Investigational Site 52049
Hunedoara, Romania, 331057
Teva Investigational Site 52042
Iasi, Romania, 700661
Teva Investigational Site 52039
Oradea, Romania, 410108
Teva Investigational Site 52047
Piatra-Neamt, Romania, 610136
Teva Investigational Site 52046
Sibiu, Romania, 550245
Teva Investigational Site 52035
Targu Mures, Romania
Teva Investigational Site 52043
Timisoara, Romania, 100182
Russian Federation
Teva Investigational Site 50130
Barnaul, Russian Federation, 656024
Teva Investigational Site 50129
Chelyabinsk, Russian Federation, 454021
Teva Investigational Site 50147
Moscow, Russian Federation, 119021
Teva Investigational Site 50124
Moscow, Russian Federation, 127015
Teva Investigational Site 50133
Moscow, Russian Federation, 129110
Teva Investigational Site 50146
Moscow, Russian Federation, 129128
Teva Investigational Site 50141
Nizhny Novgorod, Russian Federation, 603076
Teva Investigational Site 50128
Nizhny Novgorod, Russian Federation, 603155
Teva Investigational Site 50131
Nizhny Novgorod, Russian Federation, 603155
Teva Investigational Site 50127
Perm, Russian Federation, 614990
Teva Investigational Site 50143
Rostov-on-Don, Russian Federation, 344015
Teva Investigational Site 50126
Saint Petersburg, Russian Federation, 191186
Teva Investigational Site 50140
Saint Petersburg, Russian Federation, 197022
Teva Investigational Site 50138
Samara, Russian Federation, 443095
Teva Investigational Site 50135
Saratov, Russian Federation, 410054
Teva Investigational Site 50136
Smolensk, Russian Federation, 214018
Teva Investigational Site 50137
St. Petersburg, Russian Federation, 194354
Teva Investigational Site 50125
Tomsk, Russian Federation, 634050
Teva Investigational Site 50139
Tyumen, Russian Federation, 625000
Teva Investigational Site 50134
Ufa, Russian Federation, 450007
Teva Investigational Site 50132
Volgograd, Russian Federation, 400138
Teva Investigational Site 50142
Yaroslavl, Russian Federation, 150030
Serbia
Teva Investigational Site 61025
Belgrade, Serbia, 11000
Teva Investigational Site 61027
Belgrade, Serbia, 11000
Teva Investigational Site 61024
Belgrade, Serbia, 11080
Teva Investigational Site 61018
Cacak, Serbia, 32000
Teva Investigational Site 61015
Kragujevac, Serbia, 34000
Teva Investigational Site 61014
Nis, Serbia, 18000
Teva Investigational Site 61019
Sombar, Serbia, 25000
Teva Investigational Site 61016
Subotica, Serbia, 24000
Teva Investigational Site 61017
Uzice, Serbia, 31000
Teva Investigational Site 61022
Valjevo, Serbia, 14000
Teva Investigational Site 61021
Zrenjanin, Serbia, 23000
Slovakia
Teva Investigational Site 62012
Hlohovec, Slovakia, 92001
Teva Investigational Site 62013
Trnava, Slovakia, 917 75
Spain
Teva Investigational Site 31035
Barcelona, Spain, 08025
Teva Investigational Site 31030
Barcelona, Spain, 08035
Teva Investigational Site 31031
Getafe, Spain, 28905
Teva Investigational Site 31032
Madrid, Spain, 28040
Teva Investigational Site 31034
Madrid, Spain, 28046
Teva Investigational Site 31037
Salt, Spain, 17190
Ukraine
Teva Investigational Site 58087
Chernihiv, Ukraine, 14001
Teva Investigational Site 58083
Chernivtsi, Ukraine, 58018
Teva Investigational Site 58077
Dnipropetrovsk, Ukraine, 49044
Teva Investigational Site 58088
Ivano-Frankivsk, Ukraine, 76008
Teva Investigational Site 58076
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58116
Kharkiv, Ukraine, 61068
Teva Investigational Site 58084
Kharkiv, Ukraine, 61103
Teva Investigational Site 58089
Kiev, Ukraine, 04112
Teva Investigational Site 58073
Kyiv, Ukraine, 01601
Teva Investigational Site 58078
Kyiv, Ukraine, 03110
Teva Investigational Site 58081
Kyiv, Ukraine, 03115
Teva Investigational Site 58115
Lviv, Ukraine, 79013
Teva Investigational Site 58086
Lviv, Ukraine, 79059
Teva Investigational Site 58074
Odesa, Ukraine, 65025
Teva Investigational Site 58085
Odessa, Ukraine, 65014
Teva Investigational Site 58082
Poltava, Ukraine, 36024
Teva Investigational Site 58072
Vinnytsya, Ukraine, 21005
Teva Investigational Site 58079
Zaporizhzhya, Ukraine, 69035
Teva Investigational Site 58075
Zaporizhzhya, Ukraine, 69600
United Kingdom
Teva Investigational Site 34015
Glasgow, United Kingdom, G51 4TF
Teva Investigational Site 34011
Liverpool, United Kingdom, B0T 1K0
Teva Investigational Site 34010
Liverpool, United Kingdom, L9 7LJ
Teva Investigational Site 34019
London, United Kingdom, E1 1BB
Teva Investigational Site 34016
Salford, United Kingdom, M6 8HD
Teva Investigational Site 34017
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT01707992     History of Changes
Other Study ID Numbers: LAQ-MS-305
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases