This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01707992
First received: September 28, 2012
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in subjects with RRMS. . The study has periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

Condition Intervention Phase
Multiple Sclerosis Drug: Laquinimod Drug: Matching Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod (0.6 mg/d or 1.2 mg/d) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

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


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

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

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

Enrollment: 2199
Actual Study Start Date: February 28, 2013
Study Completion Date: April 19, 2017
Primary Completion Date: March 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laquinimod Dose 0.6 mg
Two capsules, one containing 0.6 mg laquinimod and the other containing matching placebo, to be administered orally once daily during both Periods 1 and 2.
Drug: Laquinimod
Experimental: Laquinimod Dose 1.2 mg

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

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

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

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects with progressive forms of MS.
  • Subjects with Neuromyelitis Optica (NMO).
  • Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to randomization.
  • Use of immunosuppressive agents,or cytotoxic agents, including Cyclophosphamide within 6 months prior to randomization.
  • Use of either of the following within 2 years prior to screening visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
  • Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization.
  • Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulin (IVIG) within 2 months prior to randomization.
  • Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.
  • Previous use of Mitoxantrone (Novantrone®), Cladribine, or alemtuzumab (Lemtrada®).
  • Previous use of laquinimod.
  • Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  • Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to randomization.
  • Use of inducers of CYP3A4 within 2 weeks prior to randomization.
  • Pregnancy or breastfeeding.
  • A known history of sensitivity to gadolinium (Gd).
  • Inability to successfully undergo MRI scanning.
  • Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) within 3 months prior to randomization.

    • Additional criteria apply, please contact the investigator for more information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707992

  Hide Study Locations
Locations
United States, Alabama
Teva Investigational Site 10329
Cullman, Alabama, United States
United States, California
Teva Investigational Site 10310
Fresno, California, United States
United States, Colorado
Teva Investigational Site 10307
Aurora, Colorado, United States
Teva Investigational Site 10332
Fort Collins, Colorado, United States
United States, Florida
Teva Investigational Site 10316
Coral Gables, Florida, United States
Teva Investigational Site 10308
Sarasota, Florida, United States
United States, Indiana
Teva Investigational Site 10339
Fort Wayne, Indiana, United States
United States, Massachusetts
Teva Investigational Site 10338
Boston, Massachusetts, United States
United States, North Carolina
Teva Investigational Site 10347
Winston-Salem, North Carolina, United States
United States, Ohio
Teva Investigational Site 10309
Bellevue, Ohio, United States
Teva Investigational Site 10317
Columbus, Ohio, United States
Teva Investigational Site 10325
Dayton, Ohio, United States
United States, Tennessee
Teva Investigational Site 10324
Franklin, Tennessee, United States
Teva Investigational Site 10318
Nashville, Tennessee, United States
United States, Virginia
Teva Investigational Site 10330
Newport News, Virginia, United States
Teva Investigational Site 10311
Roanoke, Virginia, United States
United States, Washington
Teva Investigational Site 10335
Seattle, Washington, United States
Austria
Teva Investigational Site 33014
Linz, Austria
Teva Investigational Site 33015
Wien, Austria
Teva Investigational Site 33016
Wien, Austria
Belarus
Teva Investigational Site 68013
Grodno, Belarus
Teva Investigational Site 68008
Minsk, Belarus
Teva Investigational Site 68009
Minsk, Belarus
Teva Investigational Site 68012
Minsk, Belarus
Teva Investigational Site 68011
Vitebsk, Belarus
Bosnia and Herzegovina
Teva Investigational Site 69008
Mostar, Bosnia and Herzegovina
Teva Investigational Site 69006
Sarajevo, Bosnia and Herzegovina
Teva Investigational Site 69009
Tuzla, Bosnia and Herzegovina
Bulgaria
Teva Investigational Site 59039
Pleven, Bulgaria
Teva Investigational Site 59040
Pleven, Bulgaria
Teva Investigational Site 59061
Ruse, Bulgaria
Teva Investigational Site 59055
Shumen, Bulgaria
Teva Investigational Site 59038
Sofia, Bulgaria
Teva Investigational Site 59041
Sofia, Bulgaria
Teva Investigational Site 59042
Sofia, Bulgaria
Teva Investigational Site 59043
Sofia, Bulgaria
Teva Investigational Site 59044
Sofia, Bulgaria
Teva Investigational Site 59045
Sofia, Bulgaria
Teva Investigational Site 59048
Sofia, Bulgaria
Teva Investigational Site 59050
Sofia, Bulgaria
Teva Investigational Site 59052
Sofia, Bulgaria
Teva Investigational Site 59054
Sofia, Bulgaria
Teva Investigational Site 59057
Sofia, Bulgaria
Teva Investigational Site 59058
Sofia, Bulgaria
Teva Investigational Site 59059
Sofia, Bulgaria
Teva Investigational Site 59063
Sofia, Bulgaria
Teva Investigational Site 59046
Varna, Bulgaria
Teva Investigational Site 59051
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59053
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59060
Vidin, Bulgaria
Canada
Teva Investigational Site 11016
Saskatoon, Canada
Croatia
Teva Investigational Site 60010
Osijek, Croatia
Teva Investigational Site 60011
Varazdin, Croatia
Teva Investigational Site 60009
Zagreb, Croatia
Czechia
Teva Investigational Site 54042
Brno, Czechia
Teva Investigational Site 54043
Havirov, Czechia
Teva Investigational Site 54047
Hradec Kralove 3, Czechia
Teva Investigational Site 54046
Jihlava, Czechia
Teva Investigational Site 54044
Olomouc, Czechia
Teva Investigational Site 54048
Teplice, Czechia
Estonia
Teva Investigational Site 55005
Paernu, Estonia
Teva Investigational Site 55006
Tallinn, Estonia
Teva Investigational Site 55008
Tallinn, Estonia
Teva Investigational Site 55007
Tartu, Estonia
France
Teva Investigational Site 35075
Clermont-Ferrand Cedex 1, France
Teva Investigational Site 35077
Dijon, France
Teva Investigational Site 35073
Lille, France
Teva Investigational Site 35079
Nîmes, France
Georgia
Teva Investigational Site 81014
Tbilisi, Georgia
Teva Investigational Site 81015
Tbilisi, Georgia
Teva Investigational Site 81016
Tbilisi, Georgia
Teva Investigational Site 81017
Tbilisi, Georgia
Teva Investigational Site 81018
Tbilisi, Georgia
Teva Investigational Site 81019
Tbilisi, Georgia
Germany
Teva Investigational Site 32186
Berlin, Germany
Teva Investigational Site 32198
Berlin, Germany
Teva Investigational Site 32193
Dresden, Germany
Teva Investigational Site 32179
Hamburg, Germany
Teva Investigational Site 32201
Jena, Germany
Teva Investigational Site 32183
Koln, Germany
Teva Investigational Site 32190
Leipzig, Germany
Teva Investigational Site 32185
Magdeburg, Germany
Teva Investigational Site 32173
Ulm, Germany
Teva Investigational Site 32188
Westerstede, Germany
Greece
Teva Investigational Site 63024
Athens, Greece
Teva Investigational Site 63027
Athens, Greece
Teva Investigational Site 63025
Thessaloniki, Greece
Teva Investigational Site 63028
Thessaloniki, Greece
Hungary
Teva Investigational Site 51043
Debrecen, Hungary
Teva Investigational Site 51044
Kaposvar, Hungary
Israel
Teva Investigational Site 80023
Haifa, Israel
Teva Investigational Site 80024
Haifa, Israel
Teva Investigational Site 80020
Ramat Gan, Israel
Teva Investigational Site 80021
Tel Aviv, Israel
Italy
Teva Investigational Site 30037
Bologna, Italy
Teva Investigational Site 30031
Castelfiorentino, Italy
Teva Investigational Site 30030
Cefalù (Palermo), Italy
Teva Investigational Site 30032
Chieti, Italy
Teva Investigational Site 30023
Milano, Italy
Teva Investigational Site 30034
Napoli, Italy
Teva Investigational Site 30025
Roma, Italy
Teva Investigational Site 30026
Roma, Italy
Teva Investigational Site 30028
Roma, Italy
Teva Investigational Site 30035
Roma, Italy
Korea, Republic of
Teva Investigational Site 87001
Goyang, GYEONGGI-DO, Korea, Republic of
Teva Investigational Site 87002
Seoul, Korea, Republic of
Latvia
Teva Investigational Site 56005
Riga, Latvia
Teva Investigational Site 56006
Riga, Latvia
Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65010
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65011
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65012
Skopje, Macedonia, The Former Yugoslav Republic of
Moldova, Republic of
Teva Investigational Site 70005
Chisinau, Moldova, Republic of
Teva Investigational Site 70006
Chisinau, Moldova, Republic of
Teva Investigational Site 70008
Chisinau, Moldova, Republic of
Montenegro
Teva Investigational Site 66002
Podgorica, Montenegro
Poland
Teva Investigational Site 53071
Bialystok, Poland
Teva Investigational Site 53085
Bydgoszcz, Poland
Teva Investigational Site 53084
Czestochowa, Poland
Teva Investigational Site 53067
Gdansk, Poland
Teva Investigational Site 53069
Gdansk, Poland
Teva Investigational Site 53083
Gdansk, Poland
Teva Investigational Site 53078
Grodzisk Mazowiecki, Poland
Teva Investigational Site 53070
Katowice, Poland
Teva Investigational Site 53073
Katowice, Poland
Teva Investigational Site 53074
Katowice, Poland
Teva Investigational Site 53080
Katowice, Poland
Teva Investigational Site 53064
Konskie, Poland
Teva Investigational Site 53065
Konstancin-Jeziorna, Poland
Teva Investigational Site 53072
Koscierzyna, Poland
Teva Investigational Site 53068
Poznan / Plewiska, Poland
Teva Investigational Site 53076
Szczencin, Poland
Romania
Teva Investigational Site 52045
Balotesti, Romania
Teva Investigational Site 52041
Bucharest, Romania
Teva Investigational Site 52034
Bucuresti, Romania
Teva Investigational Site 52037
Bucuresti, Romania
Teva Investigational Site 52050
Bucuresti, Romania
Teva Investigational Site 52036
Cluj-Napoca, Romania
Teva Investigational Site 52040
Cluj-Napoca, Romania
Teva Investigational Site 52038
Constanta, Romania
Teva Investigational Site 52044
Constanta, Romania
Teva Investigational Site 52048
Dolj, Romania
Teva Investigational Site 52049
Hunedoara, Romania
Teva Investigational Site 52042
Iasi, Romania
Teva Investigational Site 52039
Oradea, Romania
Teva Investigational Site 52047
Piatra-Neamt, Romania
Teva Investigational Site 52046
Sibiu, Romania
Teva Investigational Site 52035
Targu Mures, Romania
Teva Investigational Site 52043
Timisoara, Romania
Russian Federation
Teva Investigational Site 50130
Barnaul, Russian Federation
Teva Investigational Site 50129
Chelyabinsk, Russian Federation
Teva Investigational Site 50124
Moscow, Russian Federation
Teva Investigational Site 50133
Moscow, Russian Federation
Teva Investigational Site 50146
Moscow, Russian Federation
Teva Investigational Site 50147
Moscow, Russian Federation
Teva Investigational Site 50128
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50131
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50141
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50127
Perm, Russian Federation
Teva Investigational Site 50143
Rostov-on-Don, Russian Federation
Teva Investigational Site 50126
Saint Petersburg, Russian Federation
Teva Investigational Site 50140
Saint Petersburg, Russian Federation
Teva Investigational Site 50138
Samara, Russian Federation
Teva Investigational Site 50135
Saratov, Russian Federation
Teva Investigational Site 50136
Smolensk, Russian Federation
Teva Investigational Site 50137
St. Petersburg, Russian Federation
Teva Investigational Site 50125
Tomsk, Russian Federation
Teva Investigational Site 50139
Tyumen, Russian Federation
Teva Investigational Site 50134
Ufa, Russian Federation
Teva Investigational Site 50132
Volgograd, Russian Federation
Teva Investigational Site 50142
Yaroslavl, Russian Federation
Serbia
Teva Investigational Site 61024
Belgrade, Serbia
Teva Investigational Site 61025
Belgrade, Serbia
Teva Investigational Site 61027
Belgrade, Serbia
Teva Investigational Site 61018
Cacak, Serbia
Teva Investigational Site 61015
Kragujevac, Serbia
Teva Investigational Site 61014
Nis, Serbia
Teva Investigational Site 61019
Sombar, Serbia
Teva Investigational Site 61016
Subotica, Serbia
Teva Investigational Site 61017
Uzice, Serbia
Teva Investigational Site 61022
Valjevo, Serbia
Teva Investigational Site 61021
Zrenjanin, Serbia
Slovakia
Teva Investigational Site 62012
Hlohovec, Slovakia
Teva Investigational Site 62013
Trnava, Slovakia
Spain
Teva Investigational Site 31030
Barcelona, Spain
Teva Investigational Site 31035
Barcelona, Spain
Teva Investigational Site 31031
Getafe, Spain
Teva Investigational Site 31032
Madrid, Spain
Teva Investigational Site 31034
Madrid, Spain
Teva Investigational Site 31037
Salt, Spain
Ukraine
Teva Investigational Site 58087
Chernihiv, Ukraine
Teva Investigational Site 58083
Chernivtsi, Ukraine
Teva Investigational Site 58077
Dnipropetrovsk, Ukraine
Teva Investigational Site 58076
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58088
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58084
Kharkiv, Ukraine
Teva Investigational Site 58116
Kharkiv, Ukraine
Teva Investigational Site 58089
Kiev, Ukraine
Teva Investigational Site 58073
Kyiv, Ukraine
Teva Investigational Site 58078
Kyiv, Ukraine
Teva Investigational Site 58081
Kyiv, Ukraine
Teva Investigational Site 58086
Lviv, Ukraine
Teva Investigational Site 58115
Lviv, Ukraine
Teva Investigational Site 58074
Odesa, Ukraine
Teva Investigational Site 58085
Odessa, Ukraine
Teva Investigational Site 58082
Poltava, Ukraine
Teva Investigational Site 58080
Simferopol, Ukraine
Teva Investigational Site 58072
Vinnytsya, Ukraine
Teva Investigational Site 58075
Zaporizhzhya, Ukraine
Teva Investigational Site 58079
Zaporizhzhya, Ukraine
United Kingdom
Teva Investigational Site 34015
Glasgow, United Kingdom
Teva Investigational Site 34010
Liverpool, United Kingdom
Teva Investigational Site 34011
Liverpool, United Kingdom
Teva Investigational Site 34019
London, United Kingdom
Teva Investigational Site 34016
Salford, United Kingdom
Teva Investigational Site 34017
Sheffield, United Kingdom
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01707992     History of Changes
Other Study ID Numbers: LAQ-MS-305
Study First Received: September 28, 2012
Last Updated: May 15, 2017

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

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

ClinicalTrials.gov processed this record on July 28, 2017