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

NCT01707992 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: LAQ-MS-3052012-003647-30
• Study Type: interventional
• Target: 2,199
• Locations: 27 countries
• Sites: 271

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 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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (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.

  Baseline to Month 24

Secondary Outcomes (4)

• Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15

  Baseline, Month 15

• Placebo-Controlled Phase: Time to First Confirmed Relapse (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)

  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)

  Baseline to Month 24

Other Outcomes (10)

• Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)

  Baseline up to Month 24

• Active-Treatment Phase: Number of Participants With 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

  Baseline up to Week 24

Study Arms (6)

Placebo-Controlled Phase: Placebo

PLACEBO COMPARATOR

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-Controlled Phase: Laquinimod 0.6 mg

EXPERIMENTAL

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: Laquinimod; Drug: Placebo

Placebo-Controlled Phase: Laquinimod 1.2 mg

EXPERIMENTAL

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

Active Treatment Phase: Laquinimod 0.6 mg

EXPERIMENTAL

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: Laquinimod; Drug: Placebo

Active Treatment Phase: Laquinimod 1.2 mg

EXPERIMENTAL

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

Active Treatment Phase: Off Drug

NO INTERVENTION

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.

Interventions

Laquinimod DRUG

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

Active Treatment Phase: Laquinimod 0.6 mg; Active Treatment Phase: Laquinimod 1.2 mg; Placebo-Controlled Phase: Laquinimod 0.6 mg; Placebo-Controlled Phase: Laquinimod 1.2 mg

Placebo DRUG

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

Active Treatment Phase: Laquinimod 0.6 mg; Placebo-Controlled Phase: Laquinimod 0.6 mg; Placebo-Controlled Phase: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (284)

Teva Investigational Site 10329

Cullman, Alabama, 35058, United States

Location

Teva Investigational Site 10349

Sun City, Arizona, 85351, United States

Location

Teva Investigational Site 10342

Tucson, Arizona, 85741-3537, United States

Location

Teva Investigational Site 10310

Fresno, California, 93710, United States

Location

Teva Investigational Site 10307

Aurora, Colorado, 80045, United States

Location

Teva Investigational Site 10334

Centennial, Colorado, 80112, United States

Location

Teva Investigational Site 10332

Fort Collins, Colorado, 80528, United States

Location

Teva Investigational Site 10316

Coral Gables, Florida, 33146, United States

Location

Teva Investigational Site 10308

Sarasota, Florida, 34233, United States

Location

Teva Investigational Site 10341

St. Petersburg, Florida, 33701, United States

Location

Teva Investigational Site 10315

Sunrise, Florida, 33351, United States

Location

Teva Investigational Site 10323

Tampa, Florida, 33606, United States

Location

Teva Investigational Site 10350

Chicago, Illinois, 60612, United States

Location

Teva Investigational Site 10345

Evanston, Illinois, 60201, United States

Location

Teva Investigational Site 10343

Northbrook, Illinois, 60062, United States

Location

Teva Investigational Site 10339

Fort Wayne, Indiana, 46805, United States

Location

Teva Investigational Site 10348

Lenexa, Kansas, 66214, United States

Location

Teva Investigational Site 10338

Boston, Massachusetts, 02215, United States

Location

Teva Investigational Site 10346

Advance, North Carolina, 27006, United States

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Teva Investigational Site 10347

Winston-Salem, North Carolina, 27157, United States

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Teva Investigational Site 10309

Bellevue, Ohio, 44811, United States

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Teva Investigational Site 10317

Columbus, Ohio, 43221, United States

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Teva Investigational Site 10325

Dayton, Ohio, 45417, United States

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Teva Investigational Site 10340

Hershey, Pennsylvania, 17033-0850, United States

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Teva Investigational Site 10331

Philadelphia, Pennsylvania, 19104, United States

Location

Teva Investigational Site 10313

Cordova, Tennessee, 38018, United States

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Teva Investigational Site 10324

Franklin, Tennessee, 37064, United States

Location

Teva Investigational Site 10318

Nashville, Tennessee, 37205, United States

Location

Teva Investigational Site 10319

Salt Lake City, Utah, 84103, United States

Location

Teva Investigational Site 10330

Newport News, Virginia, 23601, United States

Location

Teva Investigational Site 10311

Roanoke, Virginia, 24018, United States

Location

Teva Investigational Site 10335

Seattle, Washington, 98122, United States

Location

Teva Investigational Site 33013

Innsbruck, A-6020, Austria

Location

Teva Investigational Site 33014

Linz, 4020, Austria

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Teva Investigational Site 33016

Vienna, 1010, Austria

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Teva Investigational Site 33015

Vienna, 1090, Austria

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Teva Investigational Site 68013

Grodno, 230027, Belarus

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Teva Investigational Site 68010

Homyel, 246029, Belarus

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Teva Investigational Site 68012

Minsk, 220026, Belarus

Location

Teva Investigational Site 68009

Minsk, 220114, Belarus

Location

Teva Investigational Site 68008

Minsk, 220116, Belarus

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Teva Investigational Site 68011

Vitebsk, 210023, Belarus

Location

Teva Investigational Site 37023

Charleroi, 6000, Belgium

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Teva Investigational Site 37024

Sijsele, 8340, Belgium

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Teva Investigational Site 69008

Mostar, 88000, Bosnia and Herzegovina

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Teva Investigational Site 69006

Sarajevo, 71000, Bosnia and Herzegovina

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Teva Investigational Site 69009

Tuzla, 75000, Bosnia and Herzegovina

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Teva Investigational Site 59039

Pleven, 5800, Bulgaria

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Teva Investigational Site 59040

Pleven, 5800, Bulgaria

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Teva Investigational Site 59060

Pleven, 5800, Bulgaria

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Teva Investigational Site 59062

Plovdiv, 4002, Bulgaria

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Teva Investigational Site 59061

Rousse, 7003, Bulgaria

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Teva Investigational Site 59055

Shumen, 9700, Bulgaria

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Teva Investigational Site 59048

Sofia, 1113, Bulgaria

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Teva Investigational Site 59052

Sofia, 1113, Bulgaria

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Teva Investigational Site 59057

Sofia, 1113, Bulgaria

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Teva Investigational Site 59050

Sofia, 1142, Bulgaria

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Teva Investigational Site 59044

Sofia, 1309, Bulgaria

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Teva Investigational Site 59063

Sofia, 1407, Bulgaria

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Teva Investigational Site 59038

Sofia, 1431, Bulgaria

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Teva Investigational Site 59043

Sofia, 1431, Bulgaria

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Teva Investigational Site 59058

Sofia, 1431, Bulgaria

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Teva Investigational Site 59041

Sofia, 1527, Bulgaria

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Teva Investigational Site 59042

Sofia, 1606, Bulgaria

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Teva Investigational Site 59054

Sofia, 1606, Bulgaria

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Teva Investigational Site 59059

Sofia, 1606, Bulgaria

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Teva Investigational Site 59045

Sofia, 1750, Bulgaria

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Teva Investigational Site 59049

Stara Zagora, 6003, Bulgaria

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Teva Investigational Site 59046

Varna, 9010, Bulgaria

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Teva Investigational Site 59051

Veliko Tarnovo, 5000, Bulgaria

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Teva Investigational Site 59053

Veliko Tarnovo, 5100, Bulgaria

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Teva Investigational Site 11013

Edmonton, Alberta, T6G 1Z1, Canada

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Teva Investigational Site 11014

Burnaby, British Columbia, V5G 2X6, Canada

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Teva Investigational Site 11015

Ottawa, K1H 8L6, Canada

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Teva Investigational Site 11016

Saskatoon, S7K 0M7, Canada

Location

Teva Investigational Site 60010

Osijek, 31 000, Croatia

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Teva Investigational Site 60011

Varaždin, 42000, Croatia

Location

Teva Investigational Site 60009

Zagreb, 10000, Croatia

Location

Teva Investigational Site 54042

Brno, 602 00, Czechia

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Teva Investigational Site 54043

Havířov, 736 01, Czechia

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Teva Investigational Site 54047

Hradec Králové, 50003, Czechia

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Teva Investigational Site 54046

Jihlava, 58633, Czechia

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Teva Investigational Site 54044

Olomouc, 779 00, Czechia

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Teva Investigational Site 54045

Ostrava, 702 00, Czechia

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Teva Investigational Site 54049

Prague, 100 31, Czechia

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Teva Investigational Site 54041

Prague, 104 00, Czechia

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Teva Investigational Site 54048

Teplice, 415 29, Czechia

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Teva Investigational Site 55005

Pärnu, 80010, Estonia

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Teva Investigational Site 55008

Tallinn, EE-10138, Estonia

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Teva Investigational Site 55006

Tallinn, EE-10617, Estonia

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Teva Investigational Site 55007

Tartu, EE-51014, Estonia

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Teva Investigational Site 35075

Clermont-Ferrand, 63003, France

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Teva Investigational Site 35077

Dijon, France

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Teva Investigational Site 35073

Lille, 59000, France

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Teva Investigational Site 35076

Lyon, 69317, France

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Teva Investigational Site 35079

Nîmes, 30029, France

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Teva Investigational Site 81018

Tbilisi, 0112, Georgia

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Teva Investigational Site 81014

Tbilisi, 0141, Georgia

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Teva Investigational Site 81015

Tbilisi, 0179, Georgia

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Teva Investigational Site 81019

Tbilisi, 0179, Georgia

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Teva Investigational Site 81017

Tbilisi, 0186, Georgia

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Teva Investigational Site 81016

Tbilisi, 0194, Georgia

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Teva Investigational Site 32199

Bad Mergentheim, 97980, Germany

Location

Teva Investigational Site 32195

Berg, 82335, Germany

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Teva Investigational Site 32200

Berlin, 10117, Germany

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Teva Investigational Site 32186

Berlin, 10437, Germany

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Teva Investigational Site 32176

Berlin, 10625, Germany

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Teva Investigational Site 32174

Berlin, 10713, Germany

Location

Teva Investigational Site 32198

Berlin, 12163, Germany

Location

Teva Investigational Site 32177

Bochum, 44791, Germany

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Teva Investigational Site 32183

Cologne, 50935, Germany

Location

Teva Investigational Site 32193

Dresden, 01307, Germany

Location

Teva Investigational Site 32184

Erbach im Odenwald, 64711, Germany

Location

Teva Investigational Site 32189

Erfurt, 99089, Germany

Location

Teva Investigational Site 32203

Giessen, 35385, Germany

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Teva Investigational Site 32202

Goettigen, 37075, Germany

Location

Teva Investigational Site 32196

Halle, 06120, Germany

Location

Teva Investigational Site 32181

Hamburg, 20246, Germany

Location

Teva Investigational Site 32179

Hamburg, 22083, Germany

Location

Teva Investigational Site 32182

Hanover, 30171, Germany

Location

Teva Investigational Site 32175

Ibbenbueren, 49477, Germany

Location

Teva Investigational Site 32201

Jena, 07743, Germany

Location

Teva Investigational Site 32190

Leipzig, 4103, Germany

Location

Teva Investigational Site 32185

Magdeburg, 39120, Germany

Location

Teva Investigational Site 32191

Rostock, 18147, Germany

Location

Teva Investigational Site 32194

Teupitz, 15755, Germany

Location

Teva Investigational Site 32173

Ulm, 89081, Germany

Location

Teva Investigational Site 32197

Wermsdorf, 04773, Germany

Location

Teva Investigational Site 32188

Westerstede, 26655, Germany

Location

Teva Investigational Site 63027

Athens, 115 28, Greece

Location

Teva Investigational Site 63024

Athens, 11525, Greece

Location

Teva Investigational Site 63029

Chaïdári, 12462, Greece

Location

Teva Investigational Site 63026

Heraklion, 71110, Greece

Location

Teva Investigational Site 63030

Larissa, 41110, Greece

Location

Teva Investigational Site 63025

Thessaloniki, 54636, Greece

Location

Teva Investigational Site 63028

Thessaloniki, 57010, Greece

Location

Teva Investigational Site 51046

Budapest, 1134, Hungary

Location

Teva Investigational Site 51043

Debrecen, 4043, Hungary

Location

Teva Investigational Site 51045

Eger, H-3300, Hungary

Location

Teva Investigational Site 51044

Kaposvár, H-7400, Hungary

Location

Teva Investigational Site 80023

Haifa, 31096, Israel

Location

Teva Investigational Site 80024

Haifa, 31096, Israel

Location

Teva Investigational Site 80020

Ramat Gan, 5262160, Israel

Location

Teva Investigational Site 80021

Tel Aviv, 64239, Israel

Location

Teva Investigational Site 30037

Bologna, 40139, Italy

Location

Teva Investigational Site 30031

Castelfiorentino, 50051, Italy

Location

Teva Investigational Site 30030

Cefalù, 90015, Italy

Location

Teva Investigational Site 30032

Chieti, 66100, Italy

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Teva Investigational Site 30024

Florence, 50139, Italy

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Teva Investigational Site 30029

Gallarate, 21013, Italy

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Teva Investigational Site 30023

Milan, 20132, Italy

Location

Teva Investigational Site 30039

Milan, 20133, Italy

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Teva Investigational Site 30034

Napoli, 80131, Italy

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Teva Investigational Site 30027

Palermo, 90146, Italy

Location

Teva Investigational Site 30028

Rome, 00149, Italy

Location

Teva Investigational Site 30025

Rome, 00163, Italy

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Teva Investigational Site 30026

Rome, 00168, Italy

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Teva Investigational Site 30035

Rome, 00178, Italy

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Teva Investigational Site 30040

Verona, 37134, Italy

Location

Teva Investigational Site 56006

Riga, 1038, Latvia

Location

Teva Investigational Site 56005

Riga, LV-1005, Latvia

Location

Teva Investigational Site 70006

Chisinau, 2001, Moldova

Location

Teva Investigational Site 70005

Chisinau, 2024, Moldova

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Teva Investigational Site 70008

Chisinau, 2028, Moldova

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Teva Investigational Site 66002

Podgorica, 20000, Montenegro

Location

Teva Investigational Site 65010

Skopje, 1000, North Macedonia

Location

Teva Investigational Site 65011

Skopje, 1000, North Macedonia

Location

Teva Investigational Site 65012

Skopje, 1000, North Macedonia

Location

Teva Investigational Site 53066

Bialystok, 15-276, Poland

Location

Teva Investigational Site 53071

Bialystok, 15-402, Poland

Location

Teva Investigational Site 53085

Bydgoszcz, 85-654, Poland

Location

Teva Investigational Site 53084

Częstochowa, 42-280, Poland

Location

Teva Investigational Site 53069

Gdansk, 80-299, Poland

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Teva Investigational Site 53083

Gdansk, 80-546, Poland

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Teva Investigational Site 53067

Gdansk, 80-803, Poland

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Teva Investigational Site 53064

Gmina Końskie, 26-200, Poland

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Teva Investigational Site 53078

Grodzisk Mazowiecki, 05-825, Poland

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Teva Investigational Site 53080

Katowice, 40-555, Poland

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Teva Investigational Site 53081

Katowice, 40-650, Poland

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Teva Investigational Site 53073

Katowice, 40-684, Poland

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Teva Investigational Site 53070

Katowice, 40-749, Poland

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Teva Investigational Site 53074

Katowice, 40-752, Poland

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Teva Investigational Site 53065

Konstancin-Jeziorna, 05-510, Poland

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Teva Investigational Site 53072

Kościerzyna, 83-400, Poland

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Teva Investigational Site 53063

Lodz, 90-324, Poland

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Teva Investigational Site 53079

Olsztyn, 10-560, Poland

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Teva Investigational Site 53068

Plewiska, 62-064, Poland

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Teva Investigational Site 53076

Szczecin, 70-111, Poland

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Teva Investigational Site 52045

Baloteşti, 77015, Romania

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Teva Investigational Site 52041

Bucharest, 012071, Romania

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Teva Investigational Site 52050

Bucharest, 020125, Romania

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Teva Investigational Site 52037

Bucharest, 022328, Romania

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Teva Investigational Site 52034

Bucharest, 050098, Romania

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Teva Investigational Site 52040

Cluj-Napoca, 400006, Romania

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Teva Investigational Site 52036

Cluj-Napoca, 400437, Romania

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Teva Investigational Site 52038

Constanța, 900123, Romania

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Teva Investigational Site 52044

Constanța, 900591, Romania

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Teva Investigational Site 52048

Craiova, 200473, Romania

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Teva Investigational Site 52049

Hunedoara, 331057, Romania

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Teva Investigational Site 52042

Iași, 700661, Romania

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Teva Investigational Site 52039

Oradea, 410108, Romania

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Teva Investigational Site 52047

Piatra Neamţ, 610136, Romania

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Teva Investigational Site 52046

Sibiu, 550245, Romania

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Teva Investigational Site 52035

Târgu Mureş, Romania

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Teva Investigational Site 52043

Timișoara, 100182, Romania

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Teva Investigational Site 50130

Barnaul, 656024, Russia

Location

Teva Investigational Site 50129

Chelyabinsk, 454021, Russia

Location

Teva Investigational Site 50208

Kazan', 420021, Russia

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Teva Investigational Site 50148

Kemerovo, 650061, Russia

Location

Teva Investigational Site 50144

Krasnodar, 350012, Russia

Location

Teva Investigational Site 50147

Moscow, 119021, Russia

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Teva Investigational Site 50124

Moscow, 127015, Russia

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Teva Investigational Site 50133

Moscow, 129110, Russia

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Teva Investigational Site 50146

Moscow, 129128, Russia

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Teva Investigational Site 50141

Nizhny Novgorod, 603076, Russia

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Teva Investigational Site 50128

Nizhny Novgorod, 603155, Russia

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Teva Investigational Site 50131

Nizhny Novgorod, 603155, Russia

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Teva Investigational Site 50127

Perm, 614990, Russia

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Teva Investigational Site 50143

Rostov-on-Don, 344015, Russia

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Teva Investigational Site 50149

Rostov-on-Don, 344022, Russia

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Teva Investigational Site 50126

Saint Petersburg, 191186, Russia

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Teva Investigational Site 50137

Saint Petersburg, 194354, Russia

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Teva Investigational Site 50140

Saint Petersburg, 197022, Russia

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Teva Investigational Site 50138

Samara, 443095, Russia

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Teva Investigational Site 50135

Saratov, 410054, Russia

Location

Teva Investigational Site 50136

Smolensk, 214018, Russia

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Teva Investigational Site 50125

Tomsk, 634050, Russia

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Teva Investigational Site 50139

Tyumen, 625000, Russia

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Teva Investigational Site 50134

Ufa, 450007, Russia

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Teva Investigational Site 50132

Volgograd, 400138, Russia

Location

Teva Investigational Site 50142

Yaroslavl, 150030, Russia

Location

Teva Investigational Site 61025

Belgrade, 11000, Serbia

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Teva Investigational Site 61027

Belgrade, 11000, Serbia

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Teva Investigational Site 61024

Belgrade, 11080, Serbia

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Teva Investigational Site 61018

Čačak, 32000, Serbia

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Teva Investigational Site 61015

Kragujevac, 34000, Serbia

Location

Teva Investigational Site 61014

Niš, 18000, Serbia

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Teva Investigational Site 61019

Sombor, 25000, Serbia

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Teva Investigational Site 61016

Subotica, 24000, Serbia

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Teva Investigational Site 61017

Užice, 31000, Serbia

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Teva Investigational Site 61022

Valjevo, 14000, Serbia

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Teva Investigational Site 61026

Vrbas, 21460, Serbia

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Teva Investigational Site 61021

Zrenjanin, 23000, Serbia

Location

Teva Investigational Site 62012

Hlohovec, 92001, Slovakia

Location

Teva Investigational Site 62013

Trnava, 917 75, Slovakia

Location

Teva Investigational Site 87001

Goyang-si, 410-769, South Korea

Location

Teva Investigational Site 87003

Seoul, 03080, South Korea

Location

Teva Investigational Site 87002

Seoul, 138-736, South Korea

Location

Teva Investigational Site 31035

Barcelona, 08025, Spain

Location

Teva Investigational Site 31030

Barcelona, 08035, Spain

Location

Teva Investigational Site 31031

Getafe, 28905, Spain

Location

Teva Investigational Site 31036

L'Hospitalet de Llobregat, 08907, Spain

Location

Teva Investigational Site 31032

Madrid, 28040, Spain

Location

Teva Investigational Site 31034

Madrid, 28046, Spain

Location

Teva Investigational Site 31033

Navarro, 31008, Spain

Location

Teva Investigational Site 31039

Oviedo, 33011, Spain

Location

Teva Investigational Site 31037

Salt, 17190, Spain

Location

Teva Investigational Site 58087

Chernihiv, 14001, Ukraine

Location

Teva Investigational Site 58083

Chernivtsi, 58018, Ukraine

Location

Teva Investigational Site 58077

Dnipropetrovsk, 49044, Ukraine

Location

Teva Investigational Site 58088

Ivano-Frankivsk, 76008, Ukraine

Location

Teva Investigational Site 58076

Ivano-Frankivsk, Ukraine

Location

Teva Investigational Site 58116

Kharkiv, 61068, Ukraine

Location

Teva Investigational Site 58084

Kharkiv, 61103, Ukraine

Location

Teva Investigational Site 58089

Kiev, 04112, Ukraine

Location

Teva Investigational Site 58073

Kyiv, 01601, Ukraine

Location

Teva Investigational Site 58078

Kyiv, 03110, Ukraine

Location

Teva Investigational Site 58081

Kyiv, 03115, Ukraine

Location

Teva Investigational Site 58115

Lviv, 79013, Ukraine

Location

Teva Investigational Site 58086

Lviv, 79059, Ukraine

Location

Teva Investigational Site 58085

Odesa, 65014, Ukraine

Location

Teva Investigational Site 58074

Odesa, 65025, Ukraine

Location

Teva Investigational Site 58082

Poltava, 36024, Ukraine

Location

Teva Investigational Site 58080

Simferopol, 95000, Ukraine

Location

Teva Investigational Site 58072

Vinnytsia, 21005, Ukraine

Location

Teva Investigational Site 58079

Zaporizhzhya, 69035, Ukraine

Location

Teva Investigational Site 58075

Zaporizhzhya, 69600, Ukraine

Location

Teva Investigational Site 34015

Glasgow, G51 4TF, United Kingdom

Location

Teva Investigational Site 34011

Liverpool, B0T 1K0, United Kingdom

Location

Teva Investigational Site 34010

Liverpool, L9 7LJ, United Kingdom

Location

Teva Investigational Site 34019

London, E1 1BB, United Kingdom

Location

Teva Investigational Site 34016

Salford, M6 8HD, United Kingdom

Location

Teva Investigational Site 34017

Sheffield, S10 2JF, United Kingdom

Location

Teva Investigational Site 34013

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34378456 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

laquinimod

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

info.era-clinical@teva.de

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 16, 2012
• Study Start: February 20, 2013
• Primary Completion: April 13, 2015
• Study Completion: July 4, 2017
• Last Updated: November 9, 2021
• Results First Posted: March 13, 2019

Record last verified: 2021-11

Locations

GB (7); BO (3); BE (2); IL (4); LA (2); CR (3); HU (4); NO (3); CA (4); ES (9); SE (12); BU (24); RO (17); CZ (9); DE (27); FR (5); GR (7); IT (15); UA (20); AU (4); KR (3); SL (2); GE (6); MO (1); US (32); PL (20); RU (26)