The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Oct 15, 2012
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products R&D, Inc. is a leading global pharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a strong emphasis on delivering high-quality medicines across various therapeutic areas, Teva leverages its extensive expertise in drug development and manufacturing to advance healthcare outcomes. The company's commitment to scientific excellence and patient-centric approaches drives its clinical trial initiatives, focusing on addressing unmet medical needs and improving the quality of life for patients worldwide. Through robust partnerships and a comprehensive portfolio, Teva continues to play a pivotal role in the pharmaceutical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cullman, Alabama, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Fresno, California, United States
Aurora, Colorado, United States
Centennial, Colorado, United States
Fort Collins, Colorado, United States
Coral Gables, Florida, United States
Saint Petersburg, Florida, United States
Sarasota, Florida, United States
Sunrise, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Northbrook, Illinois, United States
Fort Wayne, Indiana, United States
Lenexa, Kansas, United States
Boston, Massachusetts, United States
Advance, North Carolina, United States
Winston Salem, North Carolina, United States
Bellevue, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Cordova, Tennessee, United States
Franklin, Tennessee, United States
Nashville, Tennessee, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
Roanoke, Virginia, United States
Seattle, Washington, United States
Innsbruck, , Austria
Linz, , Austria
Wien, , Austria
Wien, , Austria
Gomel, , Belarus
Grodno, , Belarus
Minsk, , Belarus
Minsk, , Belarus
Minsk, , Belarus
Vitebsk, , Belarus
Charleroi, , Belgium
Sijsele, , Belgium
Mostar, , Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Tuzla, , Bosnia And Herzegovina
Pleven, , Bulgaria
Pleven, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Shumen, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Veliko Tarnovo, , Bulgaria
Edmonton, Alberta, Canada
Burnaby, British Columbia, Canada
Ottawa, , Canada
Saskatoon, , Canada
Osijek, , Croatia
Varazdin, , Croatia
Zagreb, , Croatia
Brno, , Czechia
Havirov, , Czechia
Hradec Kralove 3, , Czechia
Jihlava, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Praha 10, , Czechia
Praha, , Czechia
Teplice, , Czechia
Parnu, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Clermont Ferrand Cedex 1, , France
Dijon, , France
Lille, , France
Lyon Cedex 04, , France
Nimes, , France
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Bad Mergentheim, , Germany
Berg, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Bochum, , Germany
Dresden, , Germany
Erbach, , Germany
Erfurt, , Germany
Giessen, , Germany
Goettigen, , Germany
Halle (Saale), , Germany
Hamburg, , Germany
Hamburg, , Germany
Hannover, , Germany
Ibbenburen, , Germany
Jena, , Germany
Koln, , Germany
Leipzig, , Germany
Magdeburg, , Germany
Rostock, , Germany
Teupitz, , Germany
Ulm, , Germany
Wermsdorf, , Germany
Westerstede, , Germany
Athens, , Greece
Athens, , Greece
Chaidari, , Greece
Heraklion, , Greece
Larisa, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Kaposvar, , Hungary
Haifa, , Israel
Haifa, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Bologna, , Italy
Castelfiorentino, , Italy
Cefalu, , Italy
Chieti, , Italy
Firenze, , Italy
Gallarate, , Italy
Milano, , Italy
Milano, , Italy
Napoli, , Italy
Palermo, , Italy
Rome, , Italy
Rome, , Italy
Rome, , Italy
Rome, , Italy
Verona, , Italy
Goyang Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Riga, , Latvia
Riga, , Latvia
Chisinau, , Moldova, Republic Of
Chisinau, , Moldova, Republic Of
Chisinau, , Moldova, Republic Of
Podgorica, , Montenegro
Skopje, , North Macedonia
Skopje, , North Macedonia
Skopje, , North Macedonia
Bialystok, , Poland
Bialystok, , Poland
Bydgoszcz, , Poland
Czestochowa, , Poland
Gdansk, , Poland
Gdansk, , Poland
Gdansk, , Poland
Grodzisk Mazowiecki, , Poland
Katowice, , Poland
Katowice, , Poland
Katowice, , Poland
Katowice, , Poland
Katowice, , Poland
Konskie, , Poland
Konstancin Jeziorna, , Poland
Koscierzyna, , Poland
Lodz, , Poland
Olsztyn, , Poland
Plewiska, , Poland
Szczecin, , Poland
Balotesti, , Romania
Bucharest, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Cluj Napoca, , Romania
Cluj Napoca, , Romania
Constanta, , Romania
Constanta, , Romania
Craiova, , Romania
Hunedoara, , Romania
Iasi, , Romania
Oradea, , Romania
Piatra Neamt, , Romania
Sibiu, , Romania
Targu Mures, , Romania
Timisoara, , Romania
Barnaul, , Russian Federation
Chelyabinsk, , Russian Federation
Kazan, , Russian Federation
Kemerovo, , Russian Federation
Krasnodar, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Nizhny Novgorod, , Russian Federation
Nizhny Novgorod, , Russian Federation
Nizhny Novgorod, , Russian Federation
Perm, , Russian Federation
Rostov On Don, , Russian Federation
Rostov On Don, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Samara, , Russian Federation
Saratov, , Russian Federation
Smolensk, , Russian Federation
St. Petersburg, , Russian Federation
Tomsk, , Russian Federation
Tyumen, , Russian Federation
Ufa, , Russian Federation
Volgograd, , Russian Federation
Yaroslavl, , Russian Federation
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Cacak, , Serbia
Kragujevac, , Serbia
Nis, , Serbia
Sombor, , Serbia
Subotica, , Serbia
Uzice, , Serbia
Valjevo, , Serbia
Vrbas, , Serbia
Zrenjanin, , Serbia
Hlohovec, , Slovakia
Trnava, , Slovakia
Barcelona, , Spain
Barcelona, , Spain
Getafe, , Spain
L'hospitalet De Llobregat, , Spain
Madrid, , Spain
Madrid, , Spain
Navarro, , Spain
Oviedo, , Spain
Salt, , Spain
Chernihiv, , Ukraine
Chernivtsi, , Ukraine
Dnipropetrovsk, , Ukraine
Ivano Frankivsk, , Ukraine
Ivano Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Odessa, , Ukraine
Poltava, , Ukraine
Simferopol, , Ukraine
Vinnytsya, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Salford, , United Kingdom
Sheffield, , United Kingdom
Stoke On Trent, , United Kingdom
Patients applied
Trial Officials
Teva Medical Expert, MD
Study Director
Teva Branded Pharmaceutical Products R&D, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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