Clinical trial NCT01707992: The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 2199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: Baseline to Month 24
Secondary outcomes:
measure: Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15
timeFrame: Baseline, Month 15
measure: Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)
timeFrame: Baseline to Month 24
measure: Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)
timeFrame: Baseline to Month 24
measure: Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)
timeFrame: Baseline to Month 24
Other outcomes:
measure: Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Month 24
measure: Active-Treatment Phase: Number of Participants With AEs
timeFrame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
measure: Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Week 24
measure: Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
measure: Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
timeFrame: Baseline, Endpoint (Month 24)
measure: Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters
timeFrame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)
measure: Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
timeFrame: Baseline up to Month 24
measure: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
timeFrame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
measure: Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values
timeFrame: Baseline up to Month 24
measure: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values
timeFrame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
Locations:
city: Cullman
country: United States
facility: Teva Investigational Site 10329
state: Alabama
city: Sun City
country: United States
facility: Teva Investigational Site 10349
state: Arizona
city: Tucson
country: United States
facility: Teva Investigational Site 10342
state: Arizona
city: Fresno
country: United States
facility: Teva Investigational Site 10310
state: California
city: Aurora
country: United States
facility: Teva Investigational Site 10307
state: Colorado
city: Centennial
country: United States
facility: Teva Investigational Site 10334
state: Colorado
city: Fort Collins
country: United States
facility: Teva Investigational Site 10332
state: Colorado
city: Coral Gables
country: United States
facility: Teva Investigational Site 10316
state: Florida
city: Saint Petersburg
country: United States
facility: Teva Investigational Site 10341
state: Florida
city: Sarasota
country: United States
facility: Teva Investigational Site 10308
state: Florida
city: Sunrise
country: United States
facility: Teva Investigational Site 10315
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 10323
state: Florida
city: Chicago
country: United States
facility: Teva Investigational Site 10350
state: Illinois
city: Evanston
country: United States
facility: Teva Investigational Site 10345
state: Illinois
city: Northbrook
country: United States
facility: Teva Investigational Site 10343
state: Illinois
city: Fort Wayne
country: United States
facility: Teva Investigational Site 10339
state: Indiana
city: Lenexa
country: United States
facility: Teva Investigational Site 10348
state: Kansas
city: Boston
country: United States
facility: Teva Investigational Site 10338
state: Massachusetts
city: Advance
country: United States
facility: Teva Investigational Site 10346
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 10347
state: North Carolina
city: Bellevue
country: United States
facility: Teva Investigational Site 10309
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 10317
state: Ohio
city: Dayton
country: United States
facility: Teva Investigational Site 10325
state: Ohio
city: Hershey
country: United States
facility: Teva Investigational Site 10340
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 10331
state: Pennsylvania
city: Cordova
country: United States
facility: Teva Investigational Site 10313
state: Tennessee
city: Franklin
country: United States
facility: Teva Investigational Site 10324
state: Tennessee
city: Nashville
country: United States
facility: Teva Investigational Site 10318
state: Tennessee
city: Salt Lake City
country: United States
facility: Teva Investigational Site 10319
state: Utah
city: Newport News
country: United States
facility: Teva Investigational Site 10330
state: Virginia
city: Roanoke
country: United States
facility: Teva Investigational Site 10311
state: Virginia
city: Seattle
country: United States
facility: Teva Investigational Site 10335
state: Washington
city: Innsbruck
country: Austria
facility: Teva Investigational Site 33013
city: Linz
country: Austria
facility: Teva Investigational Site 33014
city: Wien
country: Austria
facility: Teva Investigational Site 33016
city: Wien
country: Austria
facility: Teva Investigational Site 33015
city: Gomel
country: Belarus
facility: Teva Investigational Site 68010
city: Grodno
country: Belarus
facility: Teva Investigational Site 68013
city: Minsk
country: Belarus
facility: Teva Investigational Site 68012
city: Minsk
country: Belarus
facility: Teva Investigational Site 68009
city: Minsk
country: Belarus
facility: Teva Investigational Site 68008
city: Vitebsk
country: Belarus
facility: Teva Investigational Site 68011
city: Charleroi
country: Belgium
facility: Teva Investigational Site 37023
city: Sijsele
country: Belgium
facility: Teva Investigational Site 37024
city: Mostar
country: Bosnia and Herzegovina
facility: Teva Investigational Site 69008
city: Sarajevo
country: Bosnia and Herzegovina
facility: Teva Investigational Site 69006
city: Tuzla
country: Bosnia and Herzegovina
facility: Teva Investigational Site 69009
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 59039
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 59040
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 59060
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 59062
city: Ruse
country: Bulgaria
facility: Teva Investigational Site 59061
city: Shumen
country: Bulgaria
facility: Teva Investigational Site 59055
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59048
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59052
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59057
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59050
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59044
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59063
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59038
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59043
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59058
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59041
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59042
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59054
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59059
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59045
city: Stara Zagora
country: Bulgaria
facility: Teva Investigational Site 59049
city: Varna
country: Bulgaria
facility: Teva Investigational Site 59046
city: Veliko Tarnovo
country: Bulgaria
facility: Teva Investigational Site 59051
city: Veliko Tarnovo
country: Bulgaria
facility: Teva Investigational Site 59053
city: Edmonton
country: Canada
facility: Teva Investigational Site 11013
state: Alberta
city: Burnaby
country: Canada
facility: Teva Investigational Site 11014
state: British Columbia
city: Ottawa
country: Canada
facility: Teva Investigational Site 11015
city: Saskatoon
country: Canada
facility: Teva Investigational Site 11016
city: Osijek
country: Croatia
facility: Teva Investigational Site 60010
city: Varazdin
country: Croatia
facility: Teva Investigational Site 60011
city: Zagreb
country: Croatia
facility: Teva Investigational Site 60009
city: Brno
country: Czechia
facility: Teva Investigational Site 54042
city: Havirov
country: Czechia
facility: Teva Investigational Site 54043
city: Hradec Kralove 3
country: Czechia
facility: Teva Investigational Site 54047
city: Jihlava
country: Czechia
facility: Teva Investigational Site 54046
city: Olomouc
country: Czechia
facility: Teva Investigational Site 54044
city: Ostrava
country: Czechia
facility: Teva Investigational Site 54045
city: Praha 10
country: Czechia
facility: Teva Investigational Site 54049
city: Praha
country: Czechia
facility: Teva Investigational Site 54041
city: Teplice
country: Czechia
facility: Teva Investigational Site 54048
city: Parnu
country: Estonia
facility: Teva Investigational Site 55005
city: Tallinn
country: Estonia
facility: Teva Investigational Site 55008
city: Tallinn
country: Estonia
facility: Teva Investigational Site 55006
city: Tartu
country: Estonia
facility: Teva Investigational Site 55007
city: Clermont-Ferrand Cedex 1
country: France
facility: Teva Investigational Site 35075
city: Dijon
country: France
facility: Teva Investigational Site 35077
city: Lille
country: France
facility: Teva Investigational Site 35073
city: Lyon cedex 04
country: France
facility: Teva Investigational Site 35076
city: Nimes
country: France
facility: Teva Investigational Site 35079
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81018
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81014
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81015
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81019
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81017
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81016
city: Bad Mergentheim
country: Germany
facility: Teva Investigational Site 32199
city: Berg
country: Germany
facility: Teva Investigational Site 32195
city: Berlin
country: Germany
facility: Teva Investigational Site 32200
city: Berlin
country: Germany
facility: Teva Investigational Site 32186
city: Berlin
country: Germany
facility: Teva Investigational Site 32176
city: Berlin
country: Germany
facility: Teva Investigational Site 32174
city: Berlin
country: Germany
facility: Teva Investigational Site 32198
city: Bochum
country: Germany
facility: Teva Investigational Site 32177
city: Dresden
country: Germany
facility: Teva Investigational Site 32193
city: Erbach
country: Germany
facility: Teva Investigational Site 32184
city: Erfurt
country: Germany
facility: Teva Investigational Site 32189
city: Giessen
country: Germany
facility: Teva Investigational Site 32203
city: Goettigen
country: Germany
facility: Teva Investigational Site 32202
city: Halle (Saale)
country: Germany
facility: Teva Investigational Site 32196
city: Hamburg
country: Germany
facility: Teva Investigational Site 32181
city: Hamburg
country: Germany
facility: Teva Investigational Site 32179
city: Hannover
country: Germany
facility: Teva Investigational Site 32182
city: Ibbenburen
country: Germany
facility: Teva Investigational Site 32175
city: Jena
country: Germany
facility: Teva Investigational Site 32201
city: Koln
country: Germany
facility: Teva Investigational Site 32183
city: Leipzig
country: Germany
facility: Teva Investigational Site 32190
city: Magdeburg
country: Germany
facility: Teva Investigational Site 32185
city: Rostock
country: Germany
facility: Teva Investigational Site 32191
city: Teupitz
country: Germany
facility: Teva Investigational Site 32194
city: Ulm
country: Germany
facility: Teva Investigational Site 32173
city: Wermsdorf
country: Germany
facility: Teva Investigational Site 32197
city: Westerstede
country: Germany
facility: Teva Investigational Site 32188
city: Athens
country: Greece
facility: Teva Investigational Site 63027
city: Athens
country: Greece
facility: Teva Investigational Site 63024
city: Chaidari
country: Greece
facility: Teva Investigational Site 63029
city: Heraklion
country: Greece
facility: Teva Investigational Site 63026
city: Larisa
country: Greece
facility: Teva Investigational Site 63030
city: Thessaloniki
country: Greece
facility: Teva Investigational Site 63025
city: Thessaloniki
country: Greece
facility: Teva Investigational Site 63028
city: Budapest
country: Hungary
facility: Teva Investigational Site 51046
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51043
city: Eger
country: Hungary
facility: Teva Investigational Site 51045
city: Kaposvar
country: Hungary
facility: Teva Investigational Site 51044
city: Haifa
country: Israel
facility: Teva Investigational Site 80023
city: Haifa
country: Israel
facility: Teva Investigational Site 80024
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80020
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 80021
city: Bologna
country: Italy
facility: Teva Investigational Site 30037
city: Castelfiorentino
country: Italy
facility: Teva Investigational Site 30031
city: Cefalu
country: Italy
facility: Teva Investigational Site 30030
city: Chieti
country: Italy
facility: Teva Investigational Site 30032
city: Firenze
country: Italy
facility: Teva Investigational Site 30024
city: Gallarate
country: Italy
facility: Teva Investigational Site 30029
city: Milano
country: Italy
facility: Teva Investigational Site 30023
city: Milano
country: Italy
facility: Teva Investigational Site 30039
city: Napoli
country: Italy
facility: Teva Investigational Site 30034
city: Palermo
country: Italy
facility: Teva Investigational Site 30027
city: Rome
country: Italy
facility: Teva Investigational Site 30028
city: Rome
country: Italy
facility: Teva Investigational Site 30025
city: Rome
country: Italy
facility: Teva Investigational Site 30026
city: Rome
country: Italy
facility: Teva Investigational Site 30035
city: Verona
country: Italy
facility: Teva Investigational Site 30040
city: Goyang-si
country: Korea, Republic of
facility: Teva Investigational Site 87001
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87003
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87002
city: Riga
country: Latvia
facility: Teva Investigational Site 56006
city: Riga
country: Latvia
facility: Teva Investigational Site 56005
city: Chisinau
country: Moldova, Republic of
facility: Teva Investigational Site 70006
city: Chisinau
country: Moldova, Republic of
facility: Teva Investigational Site 70005
city: Chisinau
country: Moldova, Republic of
facility: Teva Investigational Site 70008
city: Podgorica
country: Montenegro
facility: Teva Investigational Site 66002
city: Skopje
country: North Macedonia
facility: Teva Investigational Site 65010
city: Skopje
country: North Macedonia
facility: Teva Investigational Site 65011
city: Skopje
country: North Macedonia
facility: Teva Investigational Site 65012
city: Bialystok
country: Poland
facility: Teva Investigational Site 53066
city: Bialystok
country: Poland
facility: Teva Investigational Site 53071
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 53085
city: Czestochowa
country: Poland
facility: Teva Investigational Site 53084
city: Gdansk
country: Poland
facility: Teva Investigational Site 53069
city: Gdansk
country: Poland
facility: Teva Investigational Site 53083
city: Gdansk
country: Poland
facility: Teva Investigational Site 53067
city: Grodzisk Mazowiecki
country: Poland
facility: Teva Investigational Site 53078
city: Katowice
country: Poland
facility: Teva Investigational Site 53080
city: Katowice
country: Poland
facility: Teva Investigational Site 53081
city: Katowice
country: Poland
facility: Teva Investigational Site 53073
city: Katowice
country: Poland
facility: Teva Investigational Site 53070
city: Katowice
country: Poland
facility: Teva Investigational Site 53074
city: Konskie
country: Poland
facility: Teva Investigational Site 53064
city: Konstancin-Jeziorna
country: Poland
facility: Teva Investigational Site 53065
city: Koscierzyna
country: Poland
facility: Teva Investigational Site 53072
city: Lodz
country: Poland
facility: Teva Investigational Site 53063
city: Olsztyn
country: Poland
facility: Teva Investigational Site 53079
city: Plewiska
country: Poland
facility: Teva Investigational Site 53068
city: Szczecin
country: Poland
facility: Teva Investigational Site 53076
city: Balotesti
country: Romania
facility: Teva Investigational Site 52045
city: Bucharest
country: Romania
facility: Teva Investigational Site 52041
city: Bucuresti
country: Romania
facility: Teva Investigational Site 52050
city: Bucuresti
country: Romania
facility: Teva Investigational Site 52037
city: Bucuresti
country: Romania
facility: Teva Investigational Site 52034
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 52040
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 52036
city: Constanta
country: Romania
facility: Teva Investigational Site 52038
city: Constanta
country: Romania
facility: Teva Investigational Site 52044
city: Craiova
country: Romania
facility: Teva Investigational Site 52048
city: Hunedoara
country: Romania
facility: Teva Investigational Site 52049
city: Iasi
country: Romania
facility: Teva Investigational Site 52042
city: Oradea
country: Romania
facility: Teva Investigational Site 52039
city: Piatra-Neamt
country: Romania
facility: Teva Investigational Site 52047
city: Sibiu
country: Romania
facility: Teva Investigational Site 52046
city: Targu Mures
country: Romania
facility: Teva Investigational Site 52035
city: Timisoara
country: Romania
facility: Teva Investigational Site 52043
city: Barnaul
country: Russian Federation
facility: Teva Investigational Site 50130
city: Chelyabinsk
country: Russian Federation
facility: Teva Investigational Site 50129
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50208
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 50148
city: Krasnodar
country: Russian Federation
facility: Teva Investigational Site 50144
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50147
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50124
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50133
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50146
city: Nizhny Novgorod
country: Russian Federation
facility: Teva Investigational Site 50141
city: Nizhny Novgorod
country: Russian Federation
facility: Teva Investigational Site 50128
city: Nizhny Novgorod
country: Russian Federation
facility: Teva Investigational Site 50131
city: Perm
country: Russian Federation
facility: Teva Investigational Site 50127
city: Rostov-on-Don
country: Russian Federation
facility: Teva Investigational Site 50143
city: Rostov-on-Don
country: Russian Federation
facility: Teva Investigational Site 50149
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 50126
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 50140
city: Samara
country: Russian Federation
facility: Teva Investigational Site 50138
city: Saratov
country: Russian Federation
facility: Teva Investigational Site 50135
city: Smolensk
country: Russian Federation
facility: Teva Investigational Site 50136
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 50137
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50125
city: Tyumen
country: Russian Federation
facility: Teva Investigational Site 50139
city: Ufa
country: Russian Federation
facility: Teva Investigational Site 50134
city: Volgograd
country: Russian Federation
facility: Teva Investigational Site 50132
city: Yaroslavl
country: Russian Federation
facility: Teva Investigational Site 50142
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61025
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61027
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61024
city: Cacak
country: Serbia
facility: Teva Investigational Site 61018
city: Kragujevac
country: Serbia
facility: Teva Investigational Site 61015
city: Nis
country: Serbia
facility: Teva Investigational Site 61014
city: Sombor
country: Serbia
facility: Teva Investigational Site 61019
city: Subotica
country: Serbia
facility: Teva Investigational Site 61016
city: Uzice
country: Serbia
facility: Teva Investigational Site 61017
city: Valjevo
country: Serbia
facility: Teva Investigational Site 61022
city: Vrbas
country: Serbia
facility: Teva Investigational Site 61026
city: Zrenjanin
country: Serbia
facility: Teva Investigational Site 61021
city: Hlohovec
country: Slovakia
facility: Teva Investigational Site 62012
city: Trnava
country: Slovakia
facility: Teva Investigational Site 62013
city: Barcelona
country: Spain
facility: Teva Investigational Site 31035
city: Barcelona
country: Spain
facility: Teva Investigational Site 31030
city: Getafe
country: Spain
facility: Teva Investigational Site 31031
city: L'Hospitalet de Llobregat
country: Spain
facility: Teva Investigational Site 31036
city: Madrid
country: Spain
facility: Teva Investigational Site 31032
city: Madrid
country: Spain
facility: Teva Investigational Site 31034
city: Navarro
country: Spain
facility: Teva Investigational Site 31033
city: Oviedo
country: Spain
facility: Teva Investigational Site 31039
city: Salt
country: Spain
facility: Teva Investigational Site 31037
city: Chernihiv
country: Ukraine
facility: Teva Investigational Site 58087
city: Chernivtsi
country: Ukraine
facility: Teva Investigational Site 58083
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58077
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 58088
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 58076
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58116
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58084
city: Kiev
country: Ukraine
facility: Teva Investigational Site 58089
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58073
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58078
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58081
city: Lviv
country: Ukraine
facility: Teva Investigational Site 58115
city: Lviv
country: Ukraine
facility: Teva Investigational Site 58086
city: Odesa
country: Ukraine
facility: Teva Investigational Site 58074
city: Odessa
country: Ukraine
facility: Teva Investigational Site 58085
city: Poltava
country: Ukraine
facility: Teva Investigational Site 58082
city: Simferopol
country: Ukraine
facility: Teva Investigational Site 58080
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 58072
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58079
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58075
city: Glasgow
country: United Kingdom
facility: Teva Investigational Site 34015
city: Liverpool
country: United Kingdom
facility: Teva Investigational Site 34011
city: Liverpool
country: United Kingdom
facility: Teva Investigational Site 34010
city: London
country: United Kingdom
facility: Teva Investigational Site 34019
city: Salford
country: United Kingdom
facility: Teva Investigational Site 34016
city: Sheffield
country: United Kingdom
facility: Teva Investigational Site 34017
city: Stoke-on-Trent
country: United Kingdom
facility: Teva Investigational Site 34013
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.