Trial record 3 of 14 for:    CONCERTO

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 March 2015 by Teva Pharmaceutical Industries
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01707992
First received: September 28, 2012
Last updated: March 23, 2015
Last verified: March 2015
  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 Active, not recruiting
Cullman, Alabama, United States
United States, California
Teva Investigational Site 10310 Active, not recruiting
Fresno, California, United States
United States, Colorado
Teva Investigational Site 10307 Active, not recruiting
Aurora, Colorado, United States
Teva Investigational Site 10332 Active, not recruiting
Fort Collins, Colorado, United States
United States, Florida
Teva Investigational Site 10316 Active, not recruiting
Miami, Florida, United States
Teva Investigational Site 10308 Active, not recruiting
Sarasota, Florida, United States
United States, Indiana
Teva Investigational Site 10339 Active, not recruiting
Fort Wayne, Indiana, United States
United States, Massachusetts
Teva Investigational Site 10338 Active, not recruiting
Boston, Massachusetts, United States
United States, North Carolina
Teva Investigational Site 10347 Active, not recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Teva Investigational Site 10309 Active, not recruiting
Bellevue, Ohio, United States
Teva Investigational Site 10317 Active, not recruiting
Columbus, Ohio, United States
Teva Investigational Site 10325 Recruiting
Dayton, Ohio, United States
United States, Tennessee
Teva Investigational Site 10324 Active, not recruiting
Franklin, Tennessee, United States
Teva Investigational Site 10318 Active, not recruiting
Nashville, Tennessee, United States
United States, Virginia
Teva Investigational Site 10330 Active, not recruiting
Newport News, Virginia, United States
Teva Investigational Site 10311 Active, not recruiting
Roanoke, Virginia, United States
United States, Washington
Teva Investigational Site 10335 Active, not recruiting
Seattle, Washington, United States
Austria
Teva Investigational Site 33013 Active, not recruiting
Innsbruck, Austria
Teva Investigational Site 33014 Active, not recruiting
Linz, Austria
Teva Investigational Site 33016 Active, not recruiting
Wien, Austria
Teva Investigational Site 33015 Active, not recruiting
Wien, Austria
Belarus
Teva Investigational Site 68013 Active, not recruiting
Grodno, Belarus
Teva Investigational Site 68008 Active, not recruiting
Minsk, Belarus
Teva Investigational Site 68009 Active, not recruiting
Minsk, Belarus
Teva Investigational Site 68012 Active, not recruiting
Minsk, Belarus
Teva Investigational Site 68011 Active, not recruiting
Vitebsk, Belarus
Bosnia and Herzegovina
Teva Investigational Site 69008 Active, not recruiting
Mostar, Bosnia and Herzegovina
Teva Investigational Site 69006 Active, not recruiting
Sarajevo, Bosnia and Herzegovina
Teva Investigational Site 69009 Active, not recruiting
Tuzla, Bosnia and Herzegovina
Bulgaria
Teva Investigational Site 59039 Active, not recruiting
Pleven, Bulgaria
Teva Investigational Site 59040 Active, not recruiting
Pleven, Bulgaria
Teva Investigational Site 59061 Active, not recruiting
Ruse, Bulgaria
Teva Investigational Site 59055 Active, not recruiting
Shumen, Bulgaria
Teva Investigational Site 59063 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59041 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59042 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59043 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59044 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59038 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59048 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59050 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59045 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59054 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59057 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59058 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59059 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59052 Active, not recruiting
Sofia, Bulgaria
Teva Investigational Site 59046 Active, not recruiting
Varna, Bulgaria
Teva Investigational Site 59051 Active, not recruiting
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59053 Active, not recruiting
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59060 Active, not recruiting
Vidin, Bulgaria
Canada
Teva Investigational Site 11016 Active, not recruiting
Saskatoon, Canada
Croatia
Teva Investigational Site 60010 Active, not recruiting
Osijek, Croatia
Teva Investigational Site 60011 Active, not recruiting
Varazdin, Croatia
Teva Investigational Site 60009 Active, not recruiting
Zagreb, Croatia
Czech Republic
Teva Investigational Site 54042 Active, not recruiting
Brno, Czech Republic
Teva Investigational Site 54043 Active, not recruiting
Havirov, Czech Republic
Teva Investigational Site 54047 Active, not recruiting
Hradec Kralove 3, Czech Republic
Teva Investigational Site 54046 Active, not recruiting
Jihlava, Czech Republic
Teva Investigational Site 54044 Active, not recruiting
Olomouc, Czech Republic
Teva Investigational Site 54048 Active, not recruiting
Teplice, Czech Republic
Estonia
Teva Investigational Site 55005 Active, not recruiting
Paernu, Estonia
Teva Investigational Site 55006 Active, not recruiting
Tallinn, Estonia
Teva Investigational Site 55008 Active, not recruiting
Tallinn, Estonia
Teva Investigational Site 55007 Active, not recruiting
Tartu, Estonia
France
Teva Investigational Site 35075 Active, not recruiting
Clermont-Ferrand Cedex 1, France
Teva Investigational Site 35077 Active, not recruiting
Dijon, France
Teva Investigational Site 35073 Active, not recruiting
Lille, France
Teva Investigational Site 35076 Active, not recruiting
Lyon cedex 04, France
Teva Investigational Site 35079 Active, not recruiting
Nîmes, France
Georgia
Teva Investigational Site 81015 Active, not recruiting
Tbilisi, Georgia
Teva Investigational Site 81014 Active, not recruiting
Tbilisi, Georgia
Teva Investigational Site 81016 Active, not recruiting
Tbilisi, Georgia
Teva Investigational Site 81017 Active, not recruiting
Tbilisi, Georgia
Teva Investigational Site 81018 Active, not recruiting
Tbilisi, Georgia
Teva Investigational Site 81019 Active, not recruiting
Tbilisi, Georgia
Germany
Teva Investigational Site 32176 Active, not recruiting
Berlin, Germany
Teva Investigational Site 32186 Active, not recruiting
Berlin, Germany
Teva Investigational Site 32198 Active, not recruiting
Berlin, Germany
Teva Investigational Site 32177 Active, not recruiting
Bochum, Germany
Teva Investigational Site 32193 Active, not recruiting
Dresden, Germany
Teva Investigational Site 32189 Active, not recruiting
Erfurt, Germany
Teva Investigational Site 32203 Active, not recruiting
Gießen, Germany
Teva Investigational Site 32202 Active, not recruiting
Goettingen, Germany
Teva Investigational Site 32196 Active, not recruiting
Halle (Saale), Germany
Teva Investigational Site 32175 Active, not recruiting
Ibbenbüren, Germany
Teva Investigational Site 32201 Active, not recruiting
Jena, Germany
Teva Investigational Site 32183 Active, not recruiting
Koln, Germany
Teva Investigational Site 32190 Active, not recruiting
Leipzig, Germany
Teva Investigational Site 32185 Active, not recruiting
Magdeburg, Germany
Teva Investigational Site 32191 Active, not recruiting
Rostock, Germany
Teva Investigational Site 32173 Active, not recruiting
Ulm, Germany
Teva Investigational Site 32188 Active, not recruiting
Westerstede, Germany
Greece
Teva Investigational Site 63024 Active, not recruiting
Athens, Greece
Teva Investigational Site 63027 Active, not recruiting
Athens, Greece
Teva Investigational Site 63025 Active, not recruiting
Thessaloniki, Greece
Teva Investigational Site 63028 Active, not recruiting
Thessaloniki, Greece
Hungary
Teva Investigational Site 51043 Active, not recruiting
Debrecen, Hungary
Teva Investigational Site 51044 Active, not recruiting
Kaposvar, Hungary
Israel
Teva Investigational Site 80023 Active, not recruiting
Haifa, Israel
Teva Investigational Site 80024 Active, not recruiting
Haifa, Israel
Teva Investigational Site 80020 Active, not recruiting
Ramat Gan, Israel
Teva Investigational Site 80021 Active, not recruiting
Tel-Aviv, Israel
Italy
Teva Investigational Site 30037 Active, not recruiting
Bologna, Italy
Teva Investigational Site 30031 Active, not recruiting
Castelfiorentino, Italy
Teva Investigational Site 30030 Active, not recruiting
Cefalù (Palermo), Italy
Teva Investigational Site 30032 Active, not recruiting
Chieti, Italy
Teva Investigational Site 30024 Active, not recruiting
Firenze, Italy
Teva Investigational Site 30029 Active, not recruiting
Gallarate (Varese), Italy
Teva Investigational Site 30039 Active, not recruiting
Milano, Italy
Teva Investigational Site 30023 Active, not recruiting
Milano, Italy
Teva Investigational Site 30034 Active, not recruiting
Napoli, Italy
Teva Investigational Site 30035 Active, not recruiting
Roma, Italy
Teva Investigational Site 30026 Active, not recruiting
Roma, Italy
Teva Investigational Site 30028 Active, not recruiting
Roma, Italy
Teva Investigational Site 30025 Active, not recruiting
Roma, Italy
Teva Investigational Site 30040 Active, not recruiting
Verona, Italy
Korea, Republic of
Teva Investigational Site 87001 Active, not recruiting
Goyang, GYEONGGI-DO, Korea, Republic of
Teva Investigational Site 87002 Active, not recruiting
Seoul, Korea, Republic of
Latvia
Teva Investigational Site 56005 Active, not recruiting
Riga, Latvia
Teva Investigational Site 56006 Active, not recruiting
Riga, Latvia
Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65010 Active, not recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65011 Active, not recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65012 Active, not recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Moldova, Republic of
Teva Investigational Site 70005 Active, not recruiting
Chisinau, Moldova, Republic of
Teva Investigational Site 70006 Active, not recruiting
Chisinau, Moldova, Republic of
Teva Investigational Site 70008 Active, not recruiting
Chisinau, Moldova, Republic of
Montenegro
Teva Investigational Site 66002 Active, not recruiting
Podgorica, Montenegro
Poland
Teva Investigational Site 53071 Active, not recruiting
Bialystok, Poland
Teva Investigational Site 53085 Active, not recruiting
Bydgoszcz, Poland
Teva Investigational Site 53084 Active, not recruiting
Czestochowa, Poland
Teva Investigational Site 53067 Active, not recruiting
Gdansk, Poland
Teva Investigational Site 53069 Active, not recruiting
Gdansk, Poland
Teva Investigational Site 53083 Active, not recruiting
Gdansk, Poland
Teva Investigational Site 53078 Active, not recruiting
Grodzisk Mazowiecki, Poland
Teva Investigational Site 53080 Active, not recruiting
Katowice, Poland
Teva Investigational Site 53073 Active, not recruiting
Katowice, Poland
Teva Investigational Site 53074 Active, not recruiting
Katowice, Poland
Teva Investigational Site 53070 Active, not recruiting
Katowice, Poland
Teva Investigational Site 53064 Active, not recruiting
Konskie, Poland
Teva Investigational Site 53065 Active, not recruiting
Konstancin-Jeziorna, Poland
Teva Investigational Site 53072 Active, not recruiting
Koscierzyna, Poland
Teva Investigational Site 53079 Active, not recruiting
Olsztyn, Poland
Teva Investigational Site 53068 Active, not recruiting
Poznan / Plewiska, Poland
Teva Investigational Site 53076 Active, not recruiting
Szczecin, Poland
Romania
Teva Investigational Site 52045 Active, not recruiting
Balotesti, Romania
Teva Investigational Site 52041 Active, not recruiting
Bucharest, Romania
Teva Investigational Site 52034 Active, not recruiting
Bucuresti, Romania
Teva Investigational Site 52037 Active, not recruiting
Bucuresti, Romania
Teva Investigational Site 52050 Active, not recruiting
Bucuresti, Romania
Teva Investigational Site 52036 Active, not recruiting
Cluj-Napoca, Romania
Teva Investigational Site 52040 Active, not recruiting
Cluj-Napoca, Romania
Teva Investigational Site 52044 Active, not recruiting
Constanta, Romania
Teva Investigational Site 52038 Active, not recruiting
Constanta, Romania
Teva Investigational Site 52048 Active, not recruiting
Dolj, Romania
Teva Investigational Site 52049 Active, not recruiting
Hunedoara, Romania
Teva Investigational Site 52042 Active, not recruiting
Iasi, Romania
Teva Investigational Site 52039 Active, not recruiting
Oradea, Romania
Teva Investigational Site 52047 Active, not recruiting
Piatra-Neamt, Romania
Teva Investigational Site 52046 Active, not recruiting
Sibiu, Romania
Teva Investigational Site 52035 Active, not recruiting
Tg. Mures, Romania
Teva Investigational Site 52043 Active, not recruiting
Timisoara, Romania
Russian Federation
Teva Investigational Site 50130 Active, not recruiting
Barnaul, Russian Federation
Teva Investigational Site 50129 Active, not recruiting
Chelyabinsk, Russian Federation
Teva Investigational Site 50124 Active, not recruiting
Moscow, Russian Federation
Teva Investigational Site 50133 Active, not recruiting
Moscow, Russian Federation
Teva Investigational Site 50146 Active, not recruiting
Moscow, Russian Federation
Teva Investigational Site 50147 Active, not recruiting
Moscow, Russian Federation
Teva Investigational Site 50128 Active, not recruiting
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50131 Active, not recruiting
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50141 Active, not recruiting
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50127 Active, not recruiting
Perm, Russian Federation
Teva Investigational Site 50143 Active, not recruiting
Rostov-on-Don, Russian Federation
Teva Investigational Site 50126 Active, not recruiting
Saint Petersburg, Russian Federation
Teva Investigational Site 50140 Active, not recruiting
Saint Petersburg, Russian Federation
Teva Investigational Site 50138 Active, not recruiting
Samara, Russian Federation
Teva Investigational Site 50135 Active, not recruiting
Saratov, Russian Federation
Teva Investigational Site 50136 Active, not recruiting
Smolensk, Russian Federation
Teva Investigational Site 50137 Active, not recruiting
St. Petersburg, Russian Federation
Teva Investigational Site 50125 Active, not recruiting
Tomsk, Russian Federation
Teva Investigational Site 50139 Active, not recruiting
Tyumen, Russian Federation
Teva Investigational Site 50134 Active, not recruiting
Ufa, Russian Federation
Teva Investigational Site 50132 Active, not recruiting
Volgograd, Russian Federation
Teva Investigational Site 50142 Active, not recruiting
Yaroslavl, Russian Federation
Serbia
Teva Investigational Site 61024 Active, not recruiting
Belgrade, Serbia
Teva Investigational Site 61025 Active, not recruiting
Belgrade, Serbia
Teva Investigational Site 61027 Active, not recruiting
Belgrade, Serbia
Teva Investigational Site 61018 Active, not recruiting
Cacak, Serbia
Teva Investigational Site 61015 Active, not recruiting
Kragujevac, Serbia
Teva Investigational Site 61014 Active, not recruiting
Nis, Serbia
Teva Investigational Site 61019 Active, not recruiting
Sombar, Serbia
Teva Investigational Site 61016 Active, not recruiting
Subotica, Serbia
Teva Investigational Site 61017 Active, not recruiting
Uzice, Serbia
Teva Investigational Site 61022 Active, not recruiting
Valjevo, Serbia
Teva Investigational Site 61021 Active, not recruiting
Zrenjanin, Serbia
Slovakia
Teva Investigational Site 62012 Active, not recruiting
Hlohovec, Slovakia
Teva Investigational Site 62013 Active, not recruiting
Trnava, Slovakia
Spain
Teva Investigational Site 31030 Active, not recruiting
Barcelona, Spain
Teva Investigational Site 31035 Active, not recruiting
Barcelona, Spain
Teva Investigational Site 31037 Active, not recruiting
Girona, Spain
Teva Investigational Site 31032 Active, not recruiting
Madrid, Spain
Teva Investigational Site 31034 Active, not recruiting
Madrid, Spain
Teva Investigational Site 31031 Active, not recruiting
Madrid, Spain
Ukraine
Teva Investigational Site 58087 Active, not recruiting
Chernihiv, Ukraine
Teva Investigational Site 58083 Active, not recruiting
Chernivtsi, Ukraine
Teva Investigational Site 58077 Active, not recruiting
Dnipropetrovsk, Ukraine
Teva Investigational Site 58088 Active, not recruiting
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58076 Active, not recruiting
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58084 Active, not recruiting
Kharkiv, Ukraine
Teva Investigational Site 58116 Active, not recruiting
Kharkiv, Ukraine
Teva Investigational Site 58089 Active, not recruiting
Kiev, Ukraine
Teva Investigational Site 58078 Active, not recruiting
Kyiv, Ukraine
Teva Investigational Site 58081 Active, not recruiting
Kyiv, Ukraine
Teva Investigational Site 58073 Active, not recruiting
Kyiv, Ukraine
Teva Investigational Site 58086 Active, not recruiting
Lviv, Ukraine
Teva Investigational Site 58115 Active, not recruiting
Lviv, Ukraine
Teva Investigational Site 58074 Active, not recruiting
Odesa, Ukraine
Teva Investigational Site 58085 Active, not recruiting
Odessa, Ukraine
Teva Investigational Site 58082 Active, not recruiting
Poltava, Ukraine
Teva Investigational Site 58072 Active, not recruiting
Vinnytsya, Ukraine
Teva Investigational Site 58075 Active, not recruiting
Zaporizhzhya, Ukraine
Teva Investigational Site 58079 Active, not recruiting
Zaporizhzhya, Ukraine
United Kingdom
Teva Investigational Site 34015 Active, not recruiting
Glasgow, United Kingdom
Teva Investigational Site 34010 Active, not recruiting
Liverpool, United Kingdom
Teva Investigational Site 34011 Active, not recruiting
Liverpool, United Kingdom
Teva Investigational Site 34019 Active, not recruiting
London, United Kingdom
Teva Investigational Site 34016 Active, not recruiting
Salford, United Kingdom
Teva Investigational Site 34017 Active, not recruiting
Sheffield, 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: March 23, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2015