|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Teva Pharmaceutical Industries |
|---|---|
| Information provided by: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00605215 |
Purpose
The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 mg with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing MS injectable drug: Interferon β-1a (Avonex®).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: laquinimod Drug: placebo Drug: Interferon β-1a (Avonex®) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With RRMS to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-Blind Design and a Reference Arm of Interferon β-1a (Avonex®) in a Rater-Blinded Design. |
| Estimated Enrollment: | 1200 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
0.6 mg Laquinimod oral once daily
|
Drug: laquinimod
0.6 mg oral once daily for 24 months
|
|
2: Placebo Comparator
oral placebo once daily
|
Drug: placebo
oral placebo once daily for 24 months
|
|
3: Active Comparator
Interferon β-1a (Avonex®) 30 mcg IM once weekly
|
Drug: Interferon β-1a (Avonex®)
Interferon β-1a (Avonex®) 30 mcg IM once weekly for 24 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Alabama Neurology Associates | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arizona | |
| Barrow Neurological Clinic | |
| Phoenix, Arizona, United States, 85013 | |
| Northwest NeuroSpecialists | |
| Tucson, Arizona, United States, 85741-3537 | |
| HOPE Research Institute | |
| Phoenix, Arizona, United States, 85050 | |
| United States, California | |
| University of California, Davis | |
| Sacramento, California, United States, 95817 | |
| Neuro Therapeutics, Inc. | |
| Pasadena, California, United States, 91105 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Neurological Services of Orlando | |
| Orlando, Florida, United States, 32806 | |
| Lovelace Scientific Resources | |
| Sarasota, Florida, United States, 34232 | |
| United States, Georgia | |
| MS Center at Shepherd - MS Dept | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| OSFMG - Neurology | |
| Peoria, Illinois, United States, 61606 | |
| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| LSU Health Sciences Center - Neurology Dept | |
| New Orleans, Louisiana, United States, 70112 | |
| Louisiana State University Health Science Center | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Maryland | |
| Maryland Center for MS - MS Dept | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New Hampshire | |
| Ayres and Associates Clinical Trials, Upper Valley Neurology/Neurosur | |
| Lebanon, New Hampshire, United States, 03766 | |
| United States, New York | |
| Dent Neurological Group LLP - Neurology Dept | |
| Amherst, New York, United States, 14226 | |
| Upstate Clinical Research, LLC | |
| Albany, New York, United States, 12205 | |
| United States, North Carolina | |
| Raleigh Neurology Associates - Neurology Dept | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Cleveland Clinic Foundation - Mellen Center - Neurology Dept | |
| Cleveland, Ohio, United States, 44195-5244 | |
| Neurological Research Institute | |
| Columbus, Ohio, United States, 43221 | |
| Neurology and Neuroscience Associates | |
| Akron, Ohio, United States, 44302 | |
| United States, Oregon | |
| Providence MS Clinic | |
| Portland, Oregon, United States, 97225 | |
| United States, Tennessee | |
| St. Thomas Neurology Group | |
| Nashville, Tennessee, United States, 37202 | |
| United States, Virginia | |
| Blue Ridge Research Center LLC | |
| Roanoke, Virginia, United States, 24018 | |
| United States, Washington | |
| Neurology & Neurosurgery Associates of Tacoma Inc., P.S. | |
| Tacoma, Washington, United States, 98405 | |
| Bulgaria | |
| UMBAL St. Marina | |
| Varna, Bulgaria, 2002 | |
| SBALNP - St. Naum - EAD | |
| Sofia, Bulgaria, 1113 | |
| Medical Institute - Ministry of Interiority | |
| Sofia, Bulgaria, 1606 | |
| National Heart Hospital, Special Hospital for Active Treatment of Cardio-vascular Diseases | |
| Sofia, Bulgaria, 1309 | |
| MHAT "Tsaritsa Yoanna - ISUL" | |
| Sofia, Bulgaria, 1527 | |
| MMA HAT Sofia - Clinic of Neurology | |
| Sofia, Bulgaria, 1606 | |
| MMA HAT Sofia - Clinic of Functional Diagnostics of Nervous System | |
| Sofia, Bulgaria, 1606 | |
| University Hospital Aleksandrovska | |
| Sofia, Bulgaria, 1431 | |
| UMBAL Pleven - Second Clinic of Neurology | |
| Pleven, Bulgaria, 5800 | |
| UMBAL Pleven - First Clinic of Neurology | |
| Pleven, Bulgaria, 5800 | |
| MHAT Shumen | |
| Shumen, Bulgaria, 9700 | |
| MHAT "Sveti Georgi" | |
| Plovdiv, Bulgaria, 4002 | |
| MHAT Stara Zagora | |
| Stara Zagora, Bulgaria, 6000 | |
| Croatia | |
| Klinical Hospital Center Split | |
| Split, Croatia, 21000 | |
| Klinical Hospital "Sestre milosrdnice" | |
| Zagreb, Croatia, 10000 | |
| Klinical Hospital Osijek | |
| Osijek, Croatia, 31000 | |
| Klinical Hospital Center Zagreb | |
| Zagreb, Croatia, 10000 | |
| General Hospital Varazdin | |
| Varazdin, Croatia, 42000 | |
| General Hospital Sveti Duh | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| General Faculty Hospital, Dpt of Neurology | |
| Praha 2, Czech Republic, 128 08 | |
| Faculty Hospital Olomouc Dpt. of Neurology | |
| Olomouc, Czech Republic, 775 20 | |
| Faculty Hospital Motol, Dpt of Neurology | |
| Praha 5, Czech Republic, 150 06 | |
| Hospital Teplice, Neurology department | |
| Telplice, Czech Republic, 415 29 | |
| Neurology Dpt. St. Anne`s University Hospital Brno | |
| Brno, Czech Republic, 656 91 | |
| Estonia | |
| West Tallinn Central Hospital | |
| Tallinn, Estonia, EE-10617 | |
| East Viru Central Hospital | |
| Kohtla-Jaerve, Estonia, 30322 | |
| Georgia | |
| Sarajishvili Institute of Clinical Neurology and Neurosurgery | |
| Tbilisi, Georgia, 0114 | |
| Medical Center Health | |
| Tbilisi, Georgia, 0179 | |
| Research Institute of Clinical Medicine | |
| Tbilisi, Georgia, 0112 | |
| Israel | |
| Carmel Medical Center-Neurology Department | |
| Haifa, Israel, 34362 | |
| Hadassah Medical Center-Neurology Dept. | |
| Jerusalem, Israel, 91120 | |
| Asaf Harofe Medical Center-Neurology Dept. | |
| Zrifin, Israel, 70300 | |
| Sheba Medical Center-MS Center | |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| Policlinico Universitario Tor Vergata - Dipartimento di Neuroscienze | |
| Roma, Italy, 00133 | |
| Ospedale Bellaria - Azienda USL di Bologna | |
| Bologna, Italy, 40139 | |
| Università Cattolica del Sacro Cuore - "Policlinico A. Gemelli"- Dip. Neuroscienze - UOC Neurologia | |
| Roma, Italy, 00168 | |
| Azienda Ospedaliera San Giovanni Battista di Torino - Dipartimento di Neuroscienze | |
| Torino, Italy, 10136 | |
| Azienda Ospedaliera S. Camillo-Forlanini - Divisione di Neurologia Centro Sclerosi Multipla | |
| Roma, Italy, 00149 | |
| Fondazione Istituto San Raffaele - G. Giglio di Cefalù - Unità Operativa Neurologia | |
| Cefalù (Palermo), Italy, 90015 | |
| Ospedale Clinicizzato - SS. Annunziata | |
| Chieti, Italy, 66100 | |
| Università degli Studi di Napoli Federico II - Dipartimento Scienze Neurologiche | |
| Napoli, Italy, 80131 | |
| Azienda Ospedaliero - Universitaria Careggi | |
| Firenze, Italy, 50139 | |
| Ospedale Santa Maria della Misericordia | |
| Perugia, Italy, 06132 | |
| Istituto Auxologico Italiano I.S. San Luca - U.O. di Neurologia | |
| Milano, Italy, 20139 | |
| ASL4 Serra Spiga | |
| Cosenza, Italy, 87100 | |
| IRCCS San Raffaele Pisana - Servizio di Neuromotoria | |
| Roma, Italy, 00163 | |
| Latvia | |
| Maritim Medical Center | |
| Riga, Latvia, 1015 | |
| Lithuania | |
| Siauliai region hospital | |
| Siauliai, Lithuania, 76231 | |
| Kaunas University of Medicine | |
| Kaunas, Lithuania, 50009 | |
| Poland | |
| SPZOZ Uniwersytecki Szpital Kliniczny nr. 1 im. Barlickiego w Lodzi, Oddzial Kliniczny Neurologii | |
| Lodz, Poland, 90-153 | |
| SPZOZ Pomorskie Centrum Traumatologii Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika w Gd | |
| Gdansk, Poland, 80-803 | |
| SPZOZ Akademickie Centrum Kliniczne-Szpital Akademii Medycznej w Gdansku | |
| Gdansk, Poland, 80-952 | |
| Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Potemkowski | |
| Szczecin, Poland, 70-019 | |
| SP ZOZ Szpital Specjalistyczny w Kościerzynie, Oddział Neurologiczny | |
| Kościerzyna, Poland, 83-400 | |
| Szpital Zachodni im. Jana Pawła II | |
| Grodzisk Mazowiecki, Poland, 05-825 | |
| Katedra i Klinika Neurologii Slaskiej Akademii Medycznej | |
| Katowice-Ligota, Poland, 40-752 | |
| Klinika Neurologii, Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | |
| Wroclaw, Poland, 50-556 | |
| Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna | |
| Warsaw, Poland, 02-957 | |
| Niepubliczny Zaklad Opieki Zdrowotnej KENDRON | |
| Bialystok, Poland, 15-420 | |
| SPZOZ Wojewodzki Szpital Specjalistyczny w Olsztynie | |
| Olsztyn, Poland, 10-561 | |
| SPSK Nr 7 Slaskiej Akademii Medycznej w Katowicach,Gornoslaskie Centrum Medyczne, Klinika Neurologii | |
| Katowice, Poland, 40-635 | |
| Wojskowy Instytut Medyczny, Klinika Neurologiczna Centralnego Szpitala Klinicznego MON | |
| Warszawa, Poland, 00-909 | |
| SPZOZ Samodzileny Publiczny Centralny Szpital Kliniczny w Warszawie | |
| Warszawa, Poland, 02-097 | |
| Puerto Rico | |
| Caribbean Center for Clinical Research | |
| Guaynabo, Puerto Rico, 00969 | |
| Romania | |
| University Emergency Hospital Bucharest,Radiology and Medical Imaging Department | |
| Bucharest, Romania, 050098 | |
| Constanta County Clinical Emergency Hospital, Neurology Department | |
| Constanta, Romania, 900591 | |
| County Clinical Hospital Cluj, Neurology Department | |
| Cluj-Napoca, Romania, 400012 | |
| Iasi Clinical Rehabilitation Hospital, Neurology Department | |
| Iasi, Romania, 700661 | |
| Fundeni Clinical Hospital, Radiology and Medical Imaging Department | |
| Bucharest, Romania, 022328 | |
| Central Military Hospital, Neurology Department | |
| Bucharest, Romania, 010825 | |
| Russian Federation | |
| RSMU, Dept. of Neurology and Neurosurgery based on City Hospital #1 | |
| Moscow, Russian Federation, 117049 | |
| RSMU, Department of Neurology | |
| Moscow, Russian Federation, 118352 | |
| Brain Institute of Russian Academy of Science | |
| St. Petersburg, Russian Federation, 197376 | |
| Novosibirsk State Regional Clinical Hospital, Center of MS | |
| Novosibirsk, Russian Federation, 630087 | |
| Leningrad Regional Hospital - Neurology Dept. | |
| St. Petersburg, Russian Federation, 194291 | |
| Samara State Medical University | |
| Samara, Russian Federation, 443095 | |
| Saint-Petersburg State Medical University n.a. I.P. Pavlov, Department of Neurology & Neurosurgery | |
| St. Petersburg, Russian Federation, 197022 | |
| Sverdlovskaya Regional Clinical Hospital#1-Neurology d | |
| Ekaterinburg, Russian Federation, 620102 | |
| Perm State Medical Academy - Department of Neurology | |
| Perm, Russian Federation, 614990 | |
| Scientific Research Institute of Neurology of Russian Academy of Medical Sciences | |
| Moscow, Russian Federation, 125367 | |
| SRI of Clinical and Experimental Lymphology, Siberian Branch of RAMS, Therapy Dpt | |
| Novosibirsk, Russian Federation, 630117 | |
| Altay Regional Clinical Hjspital-Neurology Department | |
| Barnaul, Russian Federation | |
| Bashkirian State Medical University Based on Republic Clinical Hospital | |
| Ufa, Russian Federation, 450005 | |
| Krasnoyarsk State Medical Academy Based on Yenisci Clinical Hospital | |
| Krasnoyarsk, Russian Federation | |
| Slovakia | |
| Faculty Hospital Bratislava, Dpt. of Neurology | |
| Bratislava, Slovakia, 813 69 | |
| Faculty Hospital Nitra, Dpt. of Neurology | |
| Nitra, Slovakia, 949 01 | |
| Hospital in Zilina, Dpt. Of Neurology | |
| Zilina, Slovakia, 010 01 | |
| Spain | |
| Hospital General Universitari Vall d'Hebrón | |
| Barcelona, Spain, 08035 | |
| Hospital Virgen Macarena | |
| Sevilla, Spain, 41071 | |
| Ciutat Sanitaria de Bellvitge | |
| L'Hospitalet de Llobregat, Spain, 08907 | |
| Hospital de Tortosa Verge de la Cinta | |
| Tortosa-Tarragona, Spain, 43500 | |
| Complejo Hospitalario Carlos Haya | |
| Málaga, Spain, 29010 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Mutua de Terrassa | |
| Terrassa, Spain, 08221 | |
| Hospital de Figueres-Fundacio Salut Emporda | |
| Figueres-Girona, Spain, 17600 | |
| Turkey | |
| Kocaeli University Medical Faculty | |
| Izmit, Turkey | |
| Karadeniz Teknik University Medical Faculty | |
| Trabzon, Turkey, 61080 | |
| Haydarpasa Numune Egitim ve Arastirma Hastanesi | |
| Istanbul, Turkey, 34220 | |
| Ukraine | |
| Lviv National Medical University, Chair of Neurology, Lviv Regional Clinical Hospital | |
| Lviv, Ukraine, 79010 | |
| M.I. Pirogov Vinnitsya National Medical University,O.I. Yushchenko Vinnytsya Regional Psychoneurl. H | |
| Vinnytsya, Ukraine, 21005 | |
| Ukrainian State Research Institute of Medical and Social Problems of Disability | |
| Dnipropetrovsk, Ukraine, 49027 | |
| O.M. Gorky Donetsk National Medical University | |
| Donetsk, Ukraine, 83003 | |
| Kyiv City Clinical Hospital | |
| Kyiv, Ukraine, 03110 | |
| Med. Stomatological Acad., Sklifosovsky Regional Clinical Hospital | |
| Poltava, Ukraine, 36024 | |
| State Treatment and Prophylactic Institution Central Clinical Hospital of Ukrzaliznytsya | |
| Kharkiv, Ukraine, 61018 | |
| Zaporozhye Medical Academy of Postgraduate Education located at Zaporozhye Regional Clinical Hospita | |
| Zaporizhya, Ukraine, 69600 | |
| State Treatment and Prophylactic Institution Central clinical Hospital of Ukrzaliznytsya | |
| Kharkiv, Ukraine, 61018 | |
| Institute of Neurology Psychiatry and Neurology of AMS Ukraine Department of Neuroinfections and MS | |
| Kharkiv, Ukraine, 61068 | |
| Zaporozhye State Medical University located at 6th Zaporozhye State Clinical Hospital | |
| Zaporozhys, Ukraine, 69035 | |
| Odessa Regional Clinical Hospital | |
| Odessa, Ukraine, 65117 | |
| Ivano Frankivsk Regional Clinical Hospital | |
| Ivano-Frankivsk, Ukraine, 76008 | |
| Principal Investigator: | Douglas L. Vollmer | St. Joseph's Hospital & Medical Center |
| Principal Investigator: | Per S Sorensen | Copenhagen Trial Unit, Center for Clinical Intervention Research |
More Information
| Responsible Party: | Teva Neuroscience ( Siyu Liu, Senior Director of Pan Am Clinical Operations ) |
| Study ID Numbers: | MS-LAQ-302, EUDRACT 2007-005450-23 |
| Study First Received: | January 8, 2008 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00605215 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Interferons Adjuvants, Immunologic |
Sclerosis Antiviral Agents Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
