AzTrials
AzTrials

Multiple SclerosisPhase 3CONCERTONCT01707992

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

A Phase 3 study testing Laquinimod in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 284 sites in 30 countries.

Completed

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

Official record
Search all trials

Trial summary

This 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Laquinimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,199 participants
Where
284 sitesin 30 countries
Study dates
20 Feb 2013to 4 Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

284 sites in 30 countries.

284 sites in 30 countries

United States32 sites

  • Teva Investigational Site 10346

    Advance, North Carolina, 27006

  • Teva Investigational Site 10307

    Aurora, Colorado, 80045

  • Teva Investigational Site 10309

    Bellevue, Ohio, 44811

  • Teva Investigational Site 10338

    Boston, Massachusetts, 02215

  • Teva Investigational Site 10334

    Centennial, Colorado, 80112

  • Teva Investigational Site 10350

    Chicago, Illinois, 60612

  • Teva Investigational Site 10317

    Columbus, Ohio, 43221

  • Teva Investigational Site 10316

    Coral Gables, Florida, 33146

  • Teva Investigational Site 10313

    Cordova, Tennessee, 38018

  • Teva Investigational Site 10329

    Cullman, Alabama, 35058

  • Teva Investigational Site 10325

    Dayton, Ohio, 45417

  • Teva Investigational Site 10345

    Evanston, Illinois, 60201

  • Teva Investigational Site 10332

    Fort Collins, Colorado, 80528

  • Teva Investigational Site 10339

    Fort Wayne, Indiana, 46805

  • Teva Investigational Site 10324

    Franklin, Tennessee, 37064

  • Teva Investigational Site 10310

    Fresno, California, 93710

  • Teva Investigational Site 10340

    Hershey, Pennsylvania, 17033-0850

  • Teva Investigational Site 10348

    Lenexa, Kansas, 66214

  • Teva Investigational Site 10318

    Nashville, Tennessee, 37205

  • Teva Investigational Site 10330

    Newport News, Virginia, 23601

  • Teva Investigational Site 10343

    Northbrook, Illinois, 60062

  • Teva Investigational Site 10331

    Philadelphia, Pennsylvania, 19104

  • Teva Investigational Site 10311

    Roanoke, Virginia, 24018

  • Teva Investigational Site 10319

    Salt Lake City, Utah, 84103

  • Teva Investigational Site 10308

    Sarasota, Florida, 34233

  • Teva Investigational Site 10335

    Seattle, Washington, 98122

  • Teva Investigational Site 10341

    St. Petersburg, Florida, 33701

  • Teva Investigational Site 10349

    Sun City, Arizona, 85351

  • Teva Investigational Site 10315

    Sunrise, Florida, 33351

  • Teva Investigational Site 10323

    Tampa, Florida, 33606

  • Teva Investigational Site 10342

    Tucson, Arizona, 85741-3537

  • Teva Investigational Site 10347

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany27 sites

  • Teva Investigational Site 32199

    Bad Mergentheim, 97980

  • Teva Investigational Site 32195

    Berg, 82335

  • Teva Investigational Site 32200

    Berlin, 10117

  • Teva Investigational Site 32186

    Berlin, 10437

  • Teva Investigational Site 32176

    Berlin, 10625

  • Teva Investigational Site 32174

    Berlin, 10713

  • Teva Investigational Site 32198

    Berlin, 12163

  • Teva Investigational Site 32177

    Bochum, 44791

  • Teva Investigational Site 32183

    Cologne, 50935

  • Teva Investigational Site 32193

    Dresden, 01307

  • Teva Investigational Site 32184

    Erbach im Odenwald, 64711

  • Teva Investigational Site 32189

    Erfurt, 99089

  • Teva Investigational Site 32203

    Giessen, 35385

  • Teva Investigational Site 32202

    Goettigen, 37075

  • Teva Investigational Site 32196

    Halle, 06120

  • Teva Investigational Site 32181

    Hamburg, 20246

  • Teva Investigational Site 32179

    Hamburg, 22083

  • Teva Investigational Site 32182

    Hanover, 30171

  • Teva Investigational Site 32175

    Ibbenbueren, 49477

  • Teva Investigational Site 32201

    Jena, 07743

  • Teva Investigational Site 32190

    Leipzig, 4103

  • Teva Investigational Site 32185

    Magdeburg, 39120

  • Teva Investigational Site 32191

    Rostock, 18147

  • Teva Investigational Site 32194

    Teupitz, 15755

  • Teva Investigational Site 32173

    Ulm, 89081

  • Teva Investigational Site 32197

    Wermsdorf, 04773

  • Teva Investigational Site 32188

    Westerstede, 26655

Other trials in Germany

Russia26 sites

  • Teva Investigational Site 50130

    Barnaul, 656024

  • Teva Investigational Site 50129

    Chelyabinsk, 454021

  • Teva Investigational Site 50208

    Kazan', 420021

  • Teva Investigational Site 50148

    Kemerovo, 650061

  • Teva Investigational Site 50144

    Krasnodar, 350012

  • Teva Investigational Site 50147

    Moscow, 119021

  • Teva Investigational Site 50124

    Moscow, 127015

  • Teva Investigational Site 50133

    Moscow, 129110

  • Teva Investigational Site 50146

    Moscow, 129128

  • Teva Investigational Site 50141

    Nizhny Novgorod, 603076

  • Teva Investigational Site 50128

    Nizhny Novgorod, 603155

  • Teva Investigational Site 50131

    Nizhny Novgorod, 603155

  • Teva Investigational Site 50127

    Perm, 614990

  • Teva Investigational Site 50143

    Rostov-on-Don, 344015

  • Teva Investigational Site 50149

    Rostov-on-Don, 344022

  • Teva Investigational Site 50126

    Saint Petersburg, 191186

  • Teva Investigational Site 50137

    Saint Petersburg, 194354

  • Teva Investigational Site 50140

    Saint Petersburg, 197022

  • Teva Investigational Site 50138

    Samara, 443095

  • Teva Investigational Site 50135

    Saratov, 410054

  • Teva Investigational Site 50136

    Smolensk, 214018

  • Teva Investigational Site 50125

    Tomsk, 634050

  • Teva Investigational Site 50139

    Tyumen, 625000

  • Teva Investigational Site 50134

    Ufa, 450007

  • Teva Investigational Site 50132

    Volgograd, 400138

  • Teva Investigational Site 50142

    Yaroslavl, 150030

Other trials in Russia

Bulgaria24 sites

  • Teva Investigational Site 59039

    Pleven, 5800

  • Teva Investigational Site 59040

    Pleven, 5800

  • Teva Investigational Site 59060

    Pleven, 5800

  • Teva Investigational Site 59062

    Plovdiv, 4002

  • Teva Investigational Site 59061

    Rousse, 7003

  • Teva Investigational Site 59055

    Shumen, 9700

  • Teva Investigational Site 59048

    Sofia, 1113

  • Teva Investigational Site 59052

    Sofia, 1113

  • Teva Investigational Site 59057

    Sofia, 1113

  • Teva Investigational Site 59050

    Sofia, 1142

  • Teva Investigational Site 59044

    Sofia, 1309

  • Teva Investigational Site 59063

    Sofia, 1407

  • Teva Investigational Site 59038

    Sofia, 1431

  • Teva Investigational Site 59043

    Sofia, 1431

  • Teva Investigational Site 59058

    Sofia, 1431

  • Teva Investigational Site 59041

    Sofia, 1527

  • Teva Investigational Site 59042

    Sofia, 1606

  • Teva Investigational Site 59054

    Sofia, 1606

  • Teva Investigational Site 59059

    Sofia, 1606

  • Teva Investigational Site 59045

    Sofia, 1750

  • Teva Investigational Site 59049

    Stara Zagora, 6003

  • Teva Investigational Site 59046

    Varna, 9010

  • Teva Investigational Site 59051

    Veliko Tarnovo, 5000

  • Teva Investigational Site 59053

    Veliko Tarnovo, 5100

Other trials in Bulgaria

Poland20 sites

  • Teva Investigational Site 53066

    Bialystok, 15-276

  • Teva Investigational Site 53071

    Bialystok, 15-402

  • Teva Investigational Site 53085

    Bydgoszcz, 85-654

  • Teva Investigational Site 53084

    Częstochowa, 42-280

  • Teva Investigational Site 53069

    Gdansk, 80-299

  • Teva Investigational Site 53083

    Gdansk, 80-546

  • Teva Investigational Site 53067

    Gdansk, 80-803

  • Teva Investigational Site 53064

    Gmina Końskie, 26-200

  • Teva Investigational Site 53078

    Grodzisk Mazowiecki, 05-825

  • Teva Investigational Site 53080

    Katowice, 40-555

  • Teva Investigational Site 53081

    Katowice, 40-650

  • Teva Investigational Site 53073

    Katowice, 40-684

  • Teva Investigational Site 53070

    Katowice, 40-749

  • Teva Investigational Site 53074

    Katowice, 40-752

  • Teva Investigational Site 53065

    Konstancin-Jeziorna, 05-510

  • Teva Investigational Site 53072

    Kościerzyna, 83-400

  • Teva Investigational Site 53063

    Lodz, 90-324

  • Teva Investigational Site 53079

    Olsztyn, 10-560

  • Teva Investigational Site 53068

    Plewiska, 62-064

  • Teva Investigational Site 53076

    Szczecin, 70-111

Other trials in Poland

Ukraine20 sites

  • Teva Investigational Site 58087

    Chernihiv, 14001

  • Teva Investigational Site 58083

    Chernivtsi, 58018

  • Teva Investigational Site 58077

    Dnipropetrovsk, 49044

  • Teva Investigational Site 58088

    Ivano-Frankivsk, 76008

  • Teva Investigational Site 58076

    Ivano-Frankivsk

  • Teva Investigational Site 58116

    Kharkiv, 61068

  • Teva Investigational Site 58084

    Kharkiv, 61103

  • Teva Investigational Site 58089

    Kiev, 04112

  • Teva Investigational Site 58073

    Kyiv, 01601

  • Teva Investigational Site 58078

    Kyiv, 03110

  • Teva Investigational Site 58081

    Kyiv, 03115

  • Teva Investigational Site 58115

    Lviv, 79013

  • Teva Investigational Site 58086

    Lviv, 79059

  • Teva Investigational Site 58085

    Odesa, 65014

  • Teva Investigational Site 58074

    Odesa, 65025

  • Teva Investigational Site 58082

    Poltava, 36024

  • Teva Investigational Site 58080

    Simferopol, 95000

  • Teva Investigational Site 58072

    Vinnytsia, 21005

  • Teva Investigational Site 58079

    Zaporizhzhya, 69035

  • Teva Investigational Site 58075

    Zaporizhzhya, 69600

Other trials in Ukraine

Romania17 sites

  • Teva Investigational Site 52045

    Baloteşti, 77015

  • Teva Investigational Site 52041

    Bucharest, 012071

  • Teva Investigational Site 52050

    Bucharest, 020125

  • Teva Investigational Site 52037

    Bucharest, 022328

  • Teva Investigational Site 52034

    Bucharest, 050098

  • Teva Investigational Site 52040

    Cluj-Napoca, 400006

  • Teva Investigational Site 52036

    Cluj-Napoca, 400437

  • Teva Investigational Site 52038

    Constanța, 900123

  • Teva Investigational Site 52044

    Constanța, 900591

  • Teva Investigational Site 52048

    Craiova, 200473

  • Teva Investigational Site 52049

    Hunedoara, 331057

  • Teva Investigational Site 52042

    Iași, 700661

  • Teva Investigational Site 52039

    Oradea, 410108

  • Teva Investigational Site 52047

    Piatra Neamţ, 610136

  • Teva Investigational Site 52046

    Sibiu, 550245

  • Teva Investigational Site 52035

    Târgu Mureş

  • Teva Investigational Site 52043

    Timișoara, 100182

Other trials in Romania

Italy15 sites

  • Teva Investigational Site 30037

    Bologna, 40139

  • Teva Investigational Site 30031

    Castelfiorentino, 50051

  • Teva Investigational Site 30030

    Cefalù, 90015

  • Teva Investigational Site 30032

    Chieti, 66100

  • Teva Investigational Site 30024

    Florence, 50139

  • Teva Investigational Site 30029

    Gallarate, 21013

  • Teva Investigational Site 30023

    Milan, 20132

  • Teva Investigational Site 30039

    Milan, 20133

  • Teva Investigational Site 30034

    Naples, 80131

  • Teva Investigational Site 30027

    Palermo, 90146

  • Teva Investigational Site 30028

    Rome, 00149

  • Teva Investigational Site 30025

    Rome, 00163

  • Teva Investigational Site 30026

    Rome, 00168

  • Teva Investigational Site 30035

    Rome, 00178

  • Teva Investigational Site 30040

    Verona, 37134

Other trials in Italy

Serbia12 sites

  • Teva Investigational Site 61025

    Belgrade, 11000

  • Teva Investigational Site 61027

    Belgrade, 11000

  • Teva Investigational Site 61024

    Belgrade, 11080

  • Teva Investigational Site 61018

    Čačak, 32000

  • Teva Investigational Site 61015

    Kragujevac, 34000

  • Teva Investigational Site 61014

    Niš, 18000

  • Teva Investigational Site 61019

    Sombor, 25000

  • Teva Investigational Site 61016

    Subotica, 24000

  • Teva Investigational Site 61017

    Užice, 31000

  • Teva Investigational Site 61022

    Valjevo, 14000

  • Teva Investigational Site 61026

    Vrbas, 21460

  • Teva Investigational Site 61021

    Zrenjanin, 23000

Other trials in Serbia

Czechia9 sites

  • Teva Investigational Site 54042

    Brno, 602 00

  • Teva Investigational Site 54043

    Havířov, 736 01

  • Teva Investigational Site 54047

    Hradec Králové, 50003

  • Teva Investigational Site 54046

    Jihlava, 58633

  • Teva Investigational Site 54044

    Olomouc, 779 00

  • Teva Investigational Site 54045

    Ostrava, 702 00

  • Teva Investigational Site 54049

    Prague, 100 31

  • Teva Investigational Site 54041

    Prague, 104 00

  • Teva Investigational Site 54048

    Teplice, 415 29

Other trials in Czechia

Spain9 sites

  • Teva Investigational Site 31035

    Barcelona, 08025

  • Teva Investigational Site 31030

    Barcelona, 08035

  • Teva Investigational Site 31031

    Getafe, 28905

  • Teva Investigational Site 31036

    L'Hospitalet de Llobregat, 08907

  • Teva Investigational Site 31032

    Madrid, 28040

  • Teva Investigational Site 31034

    Madrid, 28046

  • Teva Investigational Site 31033

    Navarro, 31008

  • Teva Investigational Site 31039

    Oviedo, 33011

  • Teva Investigational Site 31037

    Salt, 17190

Other trials in Spain

Greece7 sites

  • Teva Investigational Site 63027

    Athens, 115 28

  • Teva Investigational Site 63024

    Athens, 11525

  • Teva Investigational Site 63029

    Chaïdári, 12462

  • Teva Investigational Site 63026

    Heraklion, 71110

  • Teva Investigational Site 63030

    Larissa, 41110

  • Teva Investigational Site 63025

    Thessaloniki, 54636

  • Teva Investigational Site 63028

    Thessaloniki, 57010

Other trials in Greece

United Kingdom7 sites

  • Teva Investigational Site 34015

    Glasgow, G51 4TF

  • Teva Investigational Site 34011

    Liverpool, B0T 1K0

  • Teva Investigational Site 34010

    Liverpool, L9 7LJ

  • Teva Investigational Site 34019

    London, E1 1BB

  • Teva Investigational Site 34016

    Salford, M6 8HD

  • Teva Investigational Site 34017

    Sheffield, S10 2JF

  • Teva Investigational Site 34013

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Belarus6 sites

  • Teva Investigational Site 68013

    Grodno, 230027

  • Teva Investigational Site 68010

    Homyel, 246029

  • Teva Investigational Site 68012

    Minsk, 220026

  • Teva Investigational Site 68009

    Minsk, 220114

  • Teva Investigational Site 68008

    Minsk, 220116

  • Teva Investigational Site 68011

    Vitebsk, 210023

Other trials in Belarus

Georgia6 sites

  • Teva Investigational Site 81018

    Tbilisi, 0112

  • Teva Investigational Site 81014

    Tbilisi, 0141

  • Teva Investigational Site 81015

    Tbilisi, 0179

  • Teva Investigational Site 81019

    Tbilisi, 0179

  • Teva Investigational Site 81017

    Tbilisi, 0186

  • Teva Investigational Site 81016

    Tbilisi, 0194

Other trials in Georgia

France5 sites

  • Teva Investigational Site 35075

    Clermont-Ferrand, 63003

  • Teva Investigational Site 35077

    Dijon

  • Teva Investigational Site 35073

    Lille, 59000

  • Teva Investigational Site 35076

    Lyon, 69317

  • Teva Investigational Site 35079

    Nîmes, 30029

Other trials in France

Austria4 sites

  • Teva Investigational Site 33013

    Innsbruck, A-6020

  • Teva Investigational Site 33014

    Linz, 4020

  • Teva Investigational Site 33016

    Vienna, 1010

  • Teva Investigational Site 33015

    Vienna, 1090

Other trials in Austria

Canada4 sites

  • Teva Investigational Site 11014

    Burnaby, British Columbia, V5G 2X6

  • Teva Investigational Site 11013

    Edmonton, Alberta, T6G 1Z1

  • Teva Investigational Site 11015

    Ottawa, K1H 8L6

  • Teva Investigational Site 11016

    Saskatoon, S7K 0M7

Other trials in Canada

Estonia4 sites

  • Teva Investigational Site 55005

    Pärnu, 80010

  • Teva Investigational Site 55008

    Tallinn, EE-10138

  • Teva Investigational Site 55006

    Tallinn, EE-10617

  • Teva Investigational Site 55007

    Tartu, EE-51014

Other trials in Estonia

Hungary4 sites

  • Teva Investigational Site 51046

    Budapest, 1134

  • Teva Investigational Site 51043

    Debrecen, 4043

  • Teva Investigational Site 51045

    Eger, H-3300

  • Teva Investigational Site 51044

    Kaposvár, H-7400

Other trials in Hungary

Israel4 sites

  • Teva Investigational Site 80023

    Haifa, 31096

  • Teva Investigational Site 80024

    Haifa, 31096

  • Teva Investigational Site 80020

    Ramat Gan, 5262160

  • Teva Investigational Site 80021

    Tel Aviv, 64239

Other trials in Israel

Bosnia and Herzegovina3 sites

  • Teva Investigational Site 69008

    Mostar, 88000

  • Teva Investigational Site 69006

    Sarajevo, 71000

  • Teva Investigational Site 69009

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Croatia3 sites

  • Teva Investigational Site 60010

    Osijek, 31 000

  • Teva Investigational Site 60011

    Varaždin, 42000

  • Teva Investigational Site 60009

    Zagreb, 10000

Other trials in Croatia

Moldova3 sites

  • Teva Investigational Site 70006

    Chisinau, 2001

  • Teva Investigational Site 70005

    Chisinau, 2024

  • Teva Investigational Site 70008

    Chisinau, 2028

Other trials in Moldova

North Macedonia3 sites

  • Teva Investigational Site 65010

    Skopje, 1000

  • Teva Investigational Site 65011

    Skopje, 1000

  • Teva Investigational Site 65012

    Skopje, 1000

Other trials in North Macedonia

South Korea3 sites

  • Teva Investigational Site 87001

    Goyang-si, 410-769

  • Teva Investigational Site 87003

    Seoul, 03080

  • Teva Investigational Site 87002

    Seoul, 138-736

Other trials in South Korea

Belgium2 sites

  • Teva Investigational Site 37023

    Charleroi, 6000

  • Teva Investigational Site 37024

    Sijsele, 8340

Other trials in Belgium

Latvia2 sites

  • Teva Investigational Site 56006

    Riga, 1038

  • Teva Investigational Site 56005

    Riga, LV-1005

Other trials in Latvia

Slovakia2 sites

  • Teva Investigational Site 62012

    Hlohovec, 92001

  • Teva Investigational Site 62013

    Trnava, 917 75

Other trials in Slovakia

Montenegro1 site

  • Teva Investigational Site 66002

    Podgorica, 20000

Other trials in Montenegro

About this study

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 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).

Being tested
Laquinimod, Placebo
Medical subject headings
Multiple Sclerosis

What participants receive

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

  • LaquinimodDrug

    Laquinimod will be administered as per the dose and schedule specified in the respective arms.

  • PlaceboDrug

    Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.

Study groups in NCT01707992
Study groupRoleWhat they receive
Placebo-Controlled Phase: PlaceboPlacebo comparatorParticipants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.
Receives: Drug: Placebo
Placebo-Controlled Phase: Laquinimod 0.6 mgExperimentalParticipants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
Receives: Drug: Laquinimod; Drug: Placebo
Placebo-Controlled Phase: Laquinimod 1.2 mgExperimentalParticipants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
Receives: Drug: Laquinimod
Active Treatment Phase: Laquinimod 0.6 mgExperimentalParticipants 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.
Receives: Drug: Laquinimod; Drug: Placebo
Active Treatment Phase: Laquinimod 1.2 mgExperimentalParticipants 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.
Receives: Drug: Laquinimod
Active Treatment Phase: Off DrugNo interventionParticipants 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 being measured

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

  1. 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 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.

    Measured: Baseline to Month 24

Secondary outcomes (4)

  1. Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at 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.

    Measured: Baseline, Month 15

  2. Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)

    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).

    Measured: Baseline to Month 24

  3. Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)

    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.

    Measured: Baseline to Month 24

  4. Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)

    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.

    Measured: Baseline to Month 24

Timeline

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

  1. First posted16 Oct 2012 (estimated)
  2. Study start20 Feb 2013
  3. Primary completion13 Apr 2015
  4. Study completion4 Jul 2017

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01707992
Sponsor's protocol ID
LAQ-MS-305
Other IDs
2012-003647-30
Acronym
CONCERTO
Status last verified
Nov 2021
First submitted
28 Sep 2012
Last updated
9 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 34378456

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laquinimod in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 284 sites in 30 countries.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 284 sites in United States, Germany, Russia, Bulgaria, Poland and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01707992, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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