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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Teva Pharmaceutical Industries
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01707992
First received: September 28, 2012
Last updated: July 29, 2014
Last verified: July 2014
  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 0.6 mg/day or 1.2mg/day in subjects with RRMS.


Condition Intervention Phase
Multiple Sclerosis (MS)
Drug: Laquinimod 0.6 mg
Drug: Matching Placebo
Drug: Laquinimod 1.2 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) in Period 1 [ Time Frame: 24 months (Period 1) ] [ Designated as safety issue: No ]
    CDP is defined as an increase in Kurtzke's Expanded Disability Status Scale (EDSS) of 1 point or more from baseline for subjects with baseline EDSS of ≤5.0, or an increase 0.5 points or more from baseline for subjects with baseline EDSS of 5.5. The EDSS rates a person's disability due to multiple sclerosis severity, ranging from 0 (normal neurological exam) to 10 (death due to MS). The higher score represents more severe disability. The outcome measure is the time recorded from Baseline until the subject meets this definition of CDP.


Secondary Outcome Measures:
  • Percent change in brain volume [ Time Frame: Change from Baseline to 15 Months ] [ Designated as safety issue: No ]
    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


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

Estimated Enrollment: 2100
Study Start Date: February 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laquinimod 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 0.6 mg
Experimental: Laquinimod 1.2 mg
Two capsules containing 0.6 mg laquinimod to be administered orally once daily during both Periods 1 and 2.
Drug: Laquinimod 1.2 mg
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

Detailed Description:

Eligible subjects with confirmed relapsing-remitting multiple sclerosis will be randomized in a 1:1:1 ratio into one of the following treatment arms: Laquinimod capsules 0.6 mg, Laquinimod capsules 1.2 mg and matching placebo. The study will be comprised of two treatment periods:

Period 1: Double-blind Placebo-controlled (DBPC) period: at least 15 months, but not more than 24 months of once-daily, oral administration of either laquinimod 0.6 mg, 1.2 mg or matching oral placebo.

The Sponsor will declare closing of Period 1 for all subjects when all ongoing enrolled subjects completed at least 15 months in Period 1.

Period 2: Active-treatment (AT) period: 24 months In this period, subjects who were assigned to either 0.6 mg or 1.2 mg daily oral laquinimod during Period 1 (DBPC) will continue with the same treatment assignment, whereas those who were assigned to placebo will receive 1.2 mg daily oral laquinimod.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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 ambulatory with Kurtzke EDSS score of 0- 5.5 in both screening and randomization visits.
  • 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 be between 18 and 55 years of age at screening, inclusive.
  • Subjects must have disease duration of at least 6 months, but not more than 12 years (from the first symptom) prior to randomization.

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. Acceptable methods of birth control include: intrauterine devices, barrier method (condom or diaphragm with spermicide) and hormonal methods of birth control (e.g. oral contraceptive, contraceptive patch, and long-acting injectable contraceptive).

  • Subjects must be able to sign and date a written informed consent prior to entering the study.
  • Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

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 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 CYP3A4 within 2 weeks prior to randomization.
  • Use of inducers of CYP3A4 within 2 weeks prior to randomization.
  • Pregnancy or breastfeeding.
  • Serum levels ≥3x upper limit of the normal range (ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at screening
  • Serum direct bilirubin which is ≥2xULN at screening.
  • Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests MRI or chest X-ray. Such conditions may include:

    • A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, de-compensated congestive heart failure, pulmonary embolism, coronary revascularization) that occurred during the past 6 months prior to randomization.
    • Any acute pulmonary disorder
    • A CNS disorder other than MS that may jeopardize the subject's participation in the study, including such disorders that are demonstrated on the baseline MRI.
    • A gastrointestinal disorder that may affect the absorption of study medication.
    • Renal disease.
    • Any form of acute or chronic liver disease.
    • Known human immunodeficiency virus positive status.
    • A history of drug and/or alcohol abuse.
    • Unstable psychiatric disorder.
    • Any malignancies, excluding basal cell carcinoma, in the 5 years prior to randomization.
  • A known history of sensitivity to gadolinium (Gd).
  • GFR ≤ 60 mL/min at the screening visit.
  • Inability to successfully undergo MRI scanning.
  • Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)within 3 months prior to randomization.
  • Known hypersensitivity that would preclude administration of laquinimod capsule, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
  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

Contacts
Contact: Teva US Medical Information 1-800-896-5855

  Hide Study Locations
Locations
United States, Alabama
Teva Investigational Site 10329 Recruiting
Cullman, Alabama, United States
United States, Arizona
Teva Investigational Site 10349 Completed
Sun City, Arizona, United States
Teva Investigational Site 10342 Completed
Tucson, Arizona, United States
United States, California
Teva Investigational Site 10310 Recruiting
Fresno, California, United States
United States, Colorado
Teva Investigational Site 10307 Recruiting
Aurora, Colorado, United States
Teva Investigational Site 10334 Completed
Denver, Colorado, United States
Teva Investigational Site 10332 Recruiting
Fort Collins, Colorado, United States
United States, Florida
Teva Investigational Site 10316 Recruiting
Miami, Florida, United States
Teva Investigational Site 10315 Completed
Plantation, Florida, United States
Teva Investigational Site 10308 Recruiting
Sarasota, Florida, United States
Teva Investigational Site 10341 Completed
St. Petersburg, Florida, United States
Teva Investigational Site 10323 Recruiting
Tampa, Florida, United States
United States, Illinois
Teva Investigational Site 10350 Completed
Chicago, Illinois, United States
Teva Investigational Site 10343 Completed
Northbrook, Illinois, United States
United States, Indiana
Teva Investigational Site 10339 Recruiting
Fort Wayne, Indiana, United States
United States, Kansas
Teva Investigational Site 10348 Completed
Lenexa, Kansas, United States
United States, Massachusetts
Teva Investigational Site 10338 Recruiting
Boston, Massachusetts, United States
United States, North Carolina
Teva Investigational Site 10346 Recruiting
Advance, North Carolina, United States
Teva Investigational Site 10347 Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Teva Investigational Site 10309 Recruiting
Bellevue, Ohio, United States
Teva Investigational Site 10317 Recruiting
Columbus, Ohio, United States
Teva Investigational Site 10325 Recruiting
Dayton, Ohio, United States
United States, Pennsylvania
Teva Investigational Site 10340 Completed
Hershey, Pennsylvania, United States
Teva Investigational Site 10331 Completed
Philadelphia, Pennsylvania, United States
United States, Tennessee
Teva Investigational Site 10313 Completed
Cordova, Tennessee, United States
Teva Investigational Site 10324 Recruiting
Franklin, Tennessee, United States
Teva Investigational Site 10318 Recruiting
Nashville, Tennessee, United States
United States, Utah
Teva Investigational Site 10319 Completed
Salt Lake City, Utah, United States
United States, Virginia
Teva Investigational Site 10330 Recruiting
Newport News, Virginia, United States
Teva Investigational Site 10311 Recruiting
Roanoke, Virginia, United States
United States, Washington
Teva Investigational Site 10335 Recruiting
Seattle, Washington, United States
Austria
Teva Investigational Site 33013 Recruiting
Innsbruck, Austria
Teva Investigational Site 33014 Recruiting
Linz, Austria
Teva Investigational Site 33015 Recruiting
Wien, Austria
Teva Investigational Site 33016 Recruiting
Wien, Austria
Belarus
Teva Investigational Site 68010 Completed
Gomel, Belarus
Teva Investigational Site 68013 Recruiting
Grodno, Belarus
Teva Investigational Site 68008 Recruiting
Minsk, Belarus
Teva Investigational Site 68012 Recruiting
Minsk, Belarus
Teva Investigational Site 68009 Recruiting
Minsk, Belarus
Teva Investigational Site 68011 Recruiting
Vitebsk, Belarus
Belgium
Teva Investigational Site 37023 Recruiting
Charleroi, Belgium
Teva Investigational Site 37024 Completed
Sijsele-Damme, Belgium
Bosnia and Herzegovina
Teva Investigational Site 69008 Recruiting
Mostar, Bosnia and Herzegovina
Teva Investigational Site 69006 Recruiting
Sarajevo, Bosnia and Herzegovina
Teva Investigational Site 69009 Recruiting
Tuzla, Bosnia and Herzegovina
Bulgaria
Teva Investigational Site 59039 Recruiting
Pleven, Bulgaria
Teva Investigational Site 59040 Recruiting
Pleven, Bulgaria
Teva Investigational Site 59062 Completed
Plovdiv, Bulgaria
Teva Investigational Site 59061 Recruiting
Ruse, Bulgaria
Teva Investigational Site 59055 Recruiting
Shumen, Bulgaria
Teva Investigational Site 59043 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59044 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59045 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59038 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59048 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59042 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59041 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59050 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59052 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59054 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59063 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59057 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59058 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59059 Recruiting
Sofia, Bulgaria
Teva Investigational Site 59049 Completed
Stara Zagora, Bulgaria
Teva Investigational Site 59046 Recruiting
Varna, Bulgaria
Teva Investigational Site 59051 Recruiting
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59053 Recruiting
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59060 Recruiting
Vidin, Bulgaria
Canada, Alberta
Teva Investigational Site 11013 Completed
Edmonton, Alberta, Canada
Canada, British Columbia
Teva Investigational Site 11014 Completed
Burnaby, British Columbia, Canada
Canada
Teva Investigational Site 11015 Completed
Ottawa, Canada
Teva Investigational Site 11016 Recruiting
Saskatoon, Canada
Croatia
Teva Investigational Site 60010 Recruiting
Osijek, Croatia
Teva Investigational Site 60011 Active, not recruiting
Varazdin, Croatia
Teva Investigational Site 60009 Recruiting
Zagreb, Croatia
Czech Republic
Teva Investigational Site 54042 Recruiting
Brno, Czech Republic
Teva Investigational Site 54043 Recruiting
Havirov, Czech Republic
Teva Investigational Site 54047 Recruiting
Hradec Kralove, Czech Republic
Teva Investigational Site 54046 Recruiting
Jihlava, Czech Republic
Teva Investigational Site 54044 Recruiting
Olomouc, Czech Republic
Teva Investigational Site 54045 Recruiting
Ostrava, Czech Republic
Teva Investigational Site 54041 Completed
Praha, Czech Republic
Teva Investigational Site 54049 Not yet recruiting
Praha 10, Czech Republic
Teva Investigational Site 54048 Recruiting
Teplice, Czech Republic
Estonia
Teva Investigational Site 55005 Recruiting
Paernu, Estonia
Teva Investigational Site 55006 Recruiting
Tallinn, Estonia
Teva Investigational Site 55008 Recruiting
Tallinn, Estonia
Teva Investigational Site 55007 Recruiting
Tartu, Estonia
France
Teva Investigational Site 35075 Recruiting
Clermont-Ferrand Cedex 1, France
Teva Investigational Site 35077 Recruiting
Dijon, France
Teva Investigational Site 35073 Recruiting
Lille, France
Teva Investigational Site 35076 Recruiting
Lyon cedex 04, France
Teva Investigational Site 35079 Recruiting
Nîmes, France
Georgia
Teva Investigational Site 81014 Recruiting
Tbilisi, Georgia
Teva Investigational Site 81015 Recruiting
Tbilisi, Georgia
Teva Investigational Site 81016 Recruiting
Tbilisi, Georgia
Teva Investigational Site 81017 Recruiting
Tbilisi, Georgia
Teva Investigational Site 81018 Recruiting
Tbilisi, Georgia
Teva Investigational Site 81019 Recruiting
Tbilisi, Georgia
Germany
Teva Investigational Site 32199 Recruiting
Bad Mergentheim, Germany
Teva Investigational Site 32195 Completed
Berg, Germany
Teva Investigational Site 32186 Recruiting
Berlin, Germany
Teva Investigational Site 32174 Recruiting
Berlin, Germany
Teva Investigational Site 32200 Recruiting
Berlin, Germany
Teva Investigational Site 32198 Recruiting
Berlin, Germany
Teva Investigational Site 32176 Recruiting
Berlin, Germany
Teva Investigational Site 32177 Recruiting
Bochum, Germany
Teva Investigational Site 32193 Recruiting
Dresden, Germany
Teva Investigational Site 32184 Completed
Erbach, Germany
Teva Investigational Site 32189 Recruiting
Erfurt, Germany
Teva Investigational Site 32203 Not yet recruiting
Gießen, Germany
Teva Investigational Site 32202 Recruiting
Goettingen, Germany
Teva Investigational Site 32196 Recruiting
Halle (Saale), Germany
Teva Investigational Site 32179 Completed
Hamburg, Germany
Teva Investigational Site 32181 Recruiting
Hamburg, Germany
Teva Investigational Site 32182 Completed
Hannover, Germany
Teva Investigational Site 32175 Recruiting
Ibbenbüren, Germany
Teva Investigational Site 32201 Recruiting
Jena, Germany
Teva Investigational Site 32183 Recruiting
Koln, Germany
Teva Investigational Site 32190 Recruiting
Leipzig, Germany
Teva Investigational Site 32185 Recruiting
Magdeburg, Germany
Teva Investigational Site 32191 Recruiting
Rostock, Germany
Teva Investigational Site 32194 Recruiting
Teupitz, Germany
Teva Investigational Site 32173 Recruiting
Ulm, Germany
Teva Investigational Site 32197 Completed
Wermsdorf, Germany
Teva Investigational Site 32188 Recruiting
Westerstede, Germany
Greece
Teva Investigational Site 63027 Recruiting
Athens, Greece
Teva Investigational Site 63024 Recruiting
Athens, Greece
Teva Investigational Site 63029 Recruiting
Chaidari, Greece
Teva Investigational Site 63026 Completed
Heraklion, Crete, Greece
Teva Investigational Site 63030 Recruiting
Larisa, Greece
Teva Investigational Site 63028 Recruiting
Thessaloniki, Greece
Teva Investigational Site 63025 Recruiting
Thessaloniki, Greece
Hungary
Teva Investigational Site 51046 Completed
Budapest, Hungary
Teva Investigational Site 51043 Recruiting
Debrecen, Hungary
Teva Investigational Site 51045 Completed
Eger, Hungary
Teva Investigational Site 51044 Recruiting
Kaposvar, Hungary
Israel
Teva Investigational Site 80023 Recruiting
Haifa, Israel
Teva Investigational Site 80024 Recruiting
Haifa, Israel
Teva Investigational Site 80020 Recruiting
Ramat Gan, Israel
Teva Investigational Site 80021 Recruiting
Tel-Aviv, Israel
Italy
Teva Investigational Site 30041 Not yet recruiting
Bari, Italy
Teva Investigational Site 30037 Recruiting
Bologna, Italy
Teva Investigational Site 30030 Recruiting
Cefalù (Palermo), Italy
Teva Investigational Site 30032 Recruiting
Chieti, Italy
Teva Investigational Site 30031 Recruiting
Empoli (FI), Italy
Teva Investigational Site 30024 Recruiting
Firenze, Italy
Teva Investigational Site 30029 Recruiting
Gallarate (Varese), Italy
Teva Investigational Site 30033 Not yet recruiting
Località Vaio - Fidenza (PR), Italy
Teva Investigational Site 30023 Recruiting
Milano, Italy
Teva Investigational Site 30039 Recruiting
Milano, Italy
Teva Investigational Site 30034 Recruiting
Napoli, Italy
Teva Investigational Site 30025 Recruiting
Roma, Italy
Teva Investigational Site 30035 Recruiting
Roma, Italy
Teva Investigational Site 30026 Recruiting
Roma, Italy
Teva Investigational Site 30028 Recruiting
Roma, Italy
Teva Investigational Site 30040 Not yet recruiting
Verona, Italy
Korea, Republic of
Teva Investigational Site 87001 Recruiting
Goyang, GYEONGGI-DO, Korea, Republic of
Teva Investigational Site 87002 Recruiting
Seoul, Korea, Republic of
Teva Investigational Site 87003 Recruiting
Seoul, Korea, Republic of
Latvia
Teva Investigational Site 56006 Recruiting
Riga, Latvia
Teva Investigational Site 56005 Recruiting
Riga, Latvia
Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65010 Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65011 Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65012 Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Moldova, Republic of
Teva Investigational Site 70006 Recruiting
Chisinau, Moldova, Republic of
Teva Investigational Site 70005 Recruiting
Chisinau, Moldova, Republic of
Teva Investigational Site 70008 Recruiting
Chisinau, Moldova, Republic of
Montenegro
Teva Investigational Site 66002 Recruiting
Podgorica, Montenegro
Poland
Teva Investigational Site 53071 Recruiting
Bialystok, Poland
Teva Investigational Site 53066 Completed
Bialystok, Poland
Teva Investigational Site 53084 Recruiting
Czestochowa, Poland
Teva Investigational Site 53067 Recruiting
Gdansk, Poland
Teva Investigational Site 53083 Recruiting
Gdansk, Poland
Teva Investigational Site 53069 Recruiting
Gdansk, Poland
Teva Investigational Site 53078 Recruiting
Grodzisk Mazowiecki, Poland
Teva Investigational Site 53085 Recruiting
Grudziadz, Poland
Teva Investigational Site 53080 Recruiting
Katowice, Poland
Teva Investigational Site 53073 Recruiting
Katowice, Poland
Teva Investigational Site 53074 Recruiting
Katowice, Poland
Teva Investigational Site 53081 Completed
Katowice, Poland
Teva Investigational Site 53070 Recruiting
Katowice, Poland
Teva Investigational Site 53064 Recruiting
Konskie, Poland
Teva Investigational Site 53065 Recruiting
Konstancin-Jeziorna, Poland
Teva Investigational Site 53072 Recruiting
Koscierzyna, Poland
Teva Investigational Site 53063 Not yet recruiting
Lodz, Poland
Teva Investigational Site 53079 Recruiting
Olsztyn, Poland
Teva Investigational Site 53068 Recruiting
Poznan / Plewiska, Poland
Teva Investigational Site 53076 Recruiting
Szczecin, Poland
Romania
Teva Investigational Site 52045 Recruiting
Balotesti, Romania
Teva Investigational Site 52041 Recruiting
Bucharest, Romania
Teva Investigational Site 52037 Recruiting
Bucuresti, Romania
Teva Investigational Site 52034 Recruiting
Bucuresti, Romania
Teva Investigational Site 52050 Recruiting
Bucuresti, Romania
Teva Investigational Site 52036 Recruiting
Cluj-Napoca, Romania
Teva Investigational Site 52040 Recruiting
Cluj-Napoca, Romania
Teva Investigational Site 52044 Recruiting
Constanta, Romania
Teva Investigational Site 52038 Recruiting
Constanta, Romania
Teva Investigational Site 52048 Recruiting
Dolj, Romania
Teva Investigational Site 52049 Recruiting
Hunedoara, Romania
Teva Investigational Site 52042 Recruiting
Iasi, Romania
Teva Investigational Site 52039 Recruiting
Oradea, Romania
Teva Investigational Site 52047 Recruiting
Piatra-Neamt, Romania
Teva Investigational Site 52046 Recruiting
Sibiu, Romania
Teva Investigational Site 52035 Recruiting
Tg. Mures, Romania
Teva Investigational Site 52043 Recruiting
Timisoara, Romania
Russian Federation
Teva Investigational Site 50130 Recruiting
Barnaul, Russian Federation
Teva Investigational Site 50129 Recruiting
Chelyabinsk, Russian Federation
Teva Investigational Site 50124 Recruiting
Moscow, Russian Federation
Teva Investigational Site 50147 Recruiting
Moscow, Russian Federation
Teva Investigational Site 50146 Recruiting
Moscow, Russian Federation
Teva Investigational Site 50133 Recruiting
Moscow, Russian Federation
Teva Investigational Site 50141 Recruiting
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50131 Recruiting
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50128 Recruiting
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50127 Recruiting
Perm, Russian Federation
Teva Investigational Site 50143 Recruiting
Rostov-on-Don, Russian Federation
Teva Investigational Site 50140 Recruiting
Saint Petersburg, Russian Federation
Teva Investigational Site 50126 Recruiting
Saint Petersburg, Russian Federation
Teva Investigational Site 50138 Recruiting
Samara, Russian Federation
Teva Investigational Site 50135 Recruiting
Saratov, Russian Federation
Teva Investigational Site 50136 Recruiting
Smolensk, Russian Federation
Teva Investigational Site 50137 Recruiting
St. Petersburg, Russian Federation
Teva Investigational Site 50125 Recruiting
Tomsk, Russian Federation
Teva Investigational Site 50139 Recruiting
Tyumen, Russian Federation
Teva Investigational Site 50134 Recruiting
Ufa, Russian Federation
Teva Investigational Site 50132 Recruiting
Volgograd, Russian Federation
Teva Investigational Site 50142 Recruiting
Yaroslavl, Russian Federation
Serbia
Teva Investigational Site 61027 Recruiting
Belgrade, Serbia
Teva Investigational Site 61025 Recruiting
Belgrade, Serbia
Teva Investigational Site 61024 Recruiting
Belgrade, Serbia
Teva Investigational Site 61018 Recruiting
Cacak, Serbia
Teva Investigational Site 61015 Recruiting
Kragujevac, Serbia
Teva Investigational Site 61014 Recruiting
Nis, Serbia
Teva Investigational Site 61019 Recruiting
Sombar, Serbia
Teva Investigational Site 61016 Recruiting
Subotica, Serbia
Teva Investigational Site 61017 Recruiting
Uzice, Serbia
Teva Investigational Site 61022 Recruiting
Valjevo, Serbia
Teva Investigational Site 61026 Completed
Vrbas, Serbia
Teva Investigational Site 61021 Recruiting
Zrenjanin, Serbia
Slovakia
Teva Investigational Site 62012 Recruiting
Hlohovec, Slovakia
Teva Investigational Site 62013 Recruiting
Trnava, Slovakia
Spain
Teva Investigational Site 31030 Recruiting
Barcelona, Spain
Teva Investigational Site 31035 Recruiting
Barcelona, Spain
Teva Investigational Site 31037 Recruiting
Girona, Spain
Teva Investigational Site 31036 Completed
L'Hospitalet de Llobregat, Spain
Teva Investigational Site 31032 Recruiting
Madrid, Spain
Teva Investigational Site 31034 Recruiting
Madrid, Spain
Teva Investigational Site 31031 Recruiting
Madrid, Spain
Teva Investigational Site 31033 Completed
Navarra, Spain
Teva Investigational Site 31039 Completed
Oviedo (Asturias), Spain
Ukraine
Teva Investigational Site 58087 Recruiting
Chernihiv, Ukraine
Teva Investigational Site 58083 Recruiting
Chernivtsi, Ukraine
Teva Investigational Site 58077 Recruiting
Dnipropetrovsk, Ukraine
Teva Investigational Site 58076 Recruiting
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58088 Recruiting
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58116 Recruiting
Kharkiv, Ukraine
Teva Investigational Site 58084 Recruiting
Kharkiv, Ukraine
Teva Investigational Site 58089 Recruiting
Kiev, Ukraine
Teva Investigational Site 58081 Recruiting
Kyiv, Ukraine
Teva Investigational Site 58078 Recruiting
Kyiv, Ukraine
Teva Investigational Site 58073 Recruiting
Kyiv, Ukraine
Teva Investigational Site 58086 Recruiting
Lviv, Ukraine
Teva Investigational Site 58115 Recruiting
Lviv, Ukraine
Teva Investigational Site 58074 Recruiting
Odesa, Ukraine
Teva Investigational Site 58085 Recruiting
Odessa, Ukraine
Teva Investigational Site 58082 Recruiting
Poltava, Ukraine
Teva Investigational Site 58080 Recruiting
Simferopol, Ukraine
Teva Investigational Site 58072 Recruiting
Vinnytsya, Ukraine
Teva Investigational Site 58079 Recruiting
Zaporizhzhya, Ukraine
Teva Investigational Site 58075 Recruiting
Zaporizhzhya, Ukraine
United Kingdom
Teva Investigational Site 34015 Recruiting
Glasgow, United Kingdom
Teva Investigational Site 34011 Recruiting
Liverpool, United Kingdom
Teva Investigational Site 34010 Recruiting
Liverpool, United Kingdom
Teva Investigational Site 34019 Recruiting
London, United Kingdom
Teva Investigational Site 34016 Recruiting
Salford, United Kingdom
Teva Investigational Site 34017 Recruiting
Sheffield, United Kingdom
Teva Investigational Site 34013 Completed
Stoke on Trent, United Kingdom
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

No publications provided

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: July 29, 2014
Health Authority: United States: Food and Drug Administration

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 September 18, 2014