A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
NCT ID: NCT00988052
Last Updated: 2021-12-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
839 participants
INTERVENTIONAL
2009-11-10
2017-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Interventions
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Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Eligibility Criteria
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Inclusion Criteria
2. Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)\] during the study and up to 30 days after the last dose of the study drug..
3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.
Exclusion Criteria
2. Pregnancy \[according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit\] or breastfeeding.
3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study.
4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
18 Years
55 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Giancarlo Comi, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
Locations
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Teva Investigational Site 1076
Phoenix, Arizona, United States
Teva Investigational Site 1090
Centennial, Colorado, United States
Teva Investigational Site 1088
Fort Collins, Colorado, United States
Teva Investigational Site 1102
Northbrook, Illinois, United States
Teva Investigational Site 1081
Fort Wayne, Indiana, United States
Teva Investigational Site 1083
Des Moines, Iowa, United States
Teva Investigational Site 1086
Kansas City, Kansas, United States
Teva Investigational Site 1101
Lexington, Kentucky, United States
Teva Investigational Site 1096
Farmington Hills, Michigan, United States
Teva Investigational Site 1093
Minneapolis, Minnesota, United States
Teva Investigational Site 1098
St Louis, Missouri, United States
Teva Investigational Site 1082
New York, New York, United States
Teva Investigational Site 1073
Winston-Salem, North Carolina, United States
Teva Investigational Site 1097
Fargo, North Dakota, United States
Teva Investigational Site 1084
Dayton, Ohio, United States
Teva Investigational Site 1092
Oklahoma City, Oklahoma, United States
Teva Investigational Site 1100
Hershey, Pennsylvania, United States
Teva Investigational Site 1075
Lubbock, Texas, United States
Teva Investigational Site 1078
San Antonio, Texas, United States
Teva Investigational Site 1085
Milwaukee, Wisconsin, United States
Teva Investigational Site 3300
Klagenfurt, , Austria
Teva Investigational Site 3303
Linz, , Austria
Teva Investigational Site 3302
Sankt Pölten, , Austria
Teva Investigational Site 5901
Pleven, , Bulgaria
Teva Investigational Site 5904
Sofia, , Bulgaria
Teva Investigational Site 5903
Sofia, , Bulgaria
Teva Investigational Site 5900
Sofia, , Bulgaria
Teva Investigational Site 5905
Sofia, , Bulgaria
Teva Investigational Site 5902
Varna, , Bulgaria
Teva Investigational Site 1132
Bedford, Nova Scotia, Canada
Teva Investigational Site 1126
London, Ontario, Canada
Teva Investigational Site 1128
Ottawa, Ontario, Canada
Teva Investigational Site 1134
Toronto, Ontario, Canada
Teva Investigational Site 1130
Greenfield Park, Quebec, Canada
Teva Investigational Site 1129
Montreal, Quebec, Canada
Teva Investigational Site 1131
Sherbrooke, Quebec, Canada
Teva Investigational Site 5417
Olomouc, , Czechia
Teva Investigational Site 5416
Ostrava - Poruba, , Czechia
Teva Investigational Site 5504
Tallinn, , Estonia
Teva Investigational Site 5505
Tartu, , Estonia
Teva Investigational Site 3525
Besançon, , France
Teva Investigational Site 3527
Bron, , France
Teva Investigational Site 3526
Clermont-Ferrand, , France
Teva Investigational Site 3524
Lille, , France
Teva Investigational Site 3528
Marseille, , France
Teva Investigational Site 3529
Rennes, , France
Teva Investigational Site 8100
Tbilisi, , Georgia
Teva Investigational Site 8101
Tbilisi, , Georgia
Teva Investigational Site 3247
Bayreuth, , Germany
Teva Investigational Site 3241
Berlin, , Germany
Teva Investigational Site 3238
Berlin, , Germany
Teva Investigational Site 3248
Bochum, , Germany
Teva Investigational Site 3245
Dresden, , Germany
Teva Investigational Site 3237
Emden, , Germany
Teva Investigational Site 3242
Erbach im Odenwald, , Germany
Teva Investigational Site 3240
Erfurt, , Germany
Teva Investigational Site 3249
Freiburg im Breisgau, , Germany
Teva Investigational Site 3236
Hamburg, , Germany
Teva Investigational Site 3246
Hamburg, , Germany
Teva Investigational Site 3239
Hanover, , Germany
Teva Investigational Site 3243
Heidelberg, , Germany
Teva Investigational Site 3251
Münster, , Germany
Teva Investigational Site 3250
Trier, , Germany
Teva Investigational Site 3244
Ulm, , Germany
Teva Investigational Site 5115
Budapest, , Hungary
Teva Investigational Site 5114
Debrecen, , Hungary
Teva Investigational Site 5116
Miskolc, , Hungary
Teva Investigational Site 5117
Veszprém, , Hungary
Teva Investigational Site 8031
Haifa, , Israel
Teva Investigational Site 8030
Jerusalem, , Israel
Teva Investigational Site 8033
Ramat Gan, , Israel
Teva Investigational Site 8032
Tel Aviv, , Israel
Teva Investigational Site 3044
Catania, , Italy
Teva Investigational Site 3045
Fidenza, , Italy
Teva Investigational Site 3042
Gallarate, , Italy
Teva Investigational Site 3046
Grosseto, , Italy
Teva Investigational Site 3038
Milan, , Italy
Teva Investigational Site 555
Milan, , Italy
Teva Investigational Site 3039
Milan, , Italy
Teva Investigational Site 3041
Palermo, , Italy
Teva Investigational Site 3040
Rome, , Italy
Teva Investigational Site 5704
Kaunas, , Lithuania
Teva Investigational Site 5705
Šiauliai, , Lithuania
Teva Investigational Site 3810
Nieuwegein, , Netherlands
Teva Investigational Site 3809
Nijmegen, , Netherlands
Teva Investigational Site 5322
Częstochowa, , Poland
Teva Investigational Site 5319
Gmina Końskie, , Poland
Teva Investigational Site 5320
Gorzów Wielkopolski, , Poland
Teva Investigational Site 5316
Katowice, , Poland
Teva Investigational Site 5318
Kielce, , Poland
Teva Investigational Site 5317
Krakow, , Poland
Teva Investigational Site 5315
Lodz, , Poland
Teva Investigational Site 5325
Warsaw, , Poland
Teva Investigational Site 5208
Bucharest, , Romania
Teva Investigational Site 5210
Cluj-Napoca, , Romania
Teva Investigational Site 5212
Constanța, , Romania
Teva Investigational Site 5211
Târgu Mureş, , Romania
Teva Investigational Site 5209
Timișoara, , Romania
Teva Investigational Site 5021
Moscow, , Russia
Teva Investigational Site 5028
Nizhny Novgorod, , Russia
Teva Investigational Site 5027
Novosibirsk, , Russia
Teva Investigational Site 5030
Perm, , Russia
Teva Investigational Site 5026
Saint Petersburg, , Russia
Teva Investigational Site 5025
Saint Petersburg, , Russia
Teva Investigational Site 5024
Saint Petersburg, , Russia
Teva Investigational Site 5022
Saint Petersburg, , Russia
Teva Investigational Site 5023
Saint Petersburg, , Russia
Teva Investigational Site 5029
Yekaterinburg, , Russia
Teva Investigational Site 6100
Belgrade, , Serbia
Teva Investigational Site 6102
Niš, , Serbia
Teva Investigational Site 3132
Barcelona, , Spain
Teva Investigational Site 3134
Barcelona, , Spain
Teva Investigational Site 3144
Barcelona, , Spain
Teva Investigational Site 3140
Beade-Pontevedra, , Spain
Teva Investigational Site 3142
Getafe, , Spain
Teva Investigational Site 3135
Lleida, , Spain
Teva Investigational Site 3133
Madrid, , Spain
Teva Investigational Site 3146
Madrid, , Spain
Teva Investigational Site 3137
Murcia, , Spain
Teva Investigational Site 3138
Pontevedra, , Spain
Teva Investigational Site 3136
Salt, , Spain
Teva Investigational Site 3139
Santiago de Compostela, , Spain
Teva Investigational Site 3143
Valencia, , Spain
Teva Investigational Site 4204
Stockholm, , Sweden
Teva Investigational Site 4205
Stockholm, , Sweden
Teva Investigational Site 4206
Stockholm, , Sweden
Teva Investigational Site 8201
Izmir, , Turkey (Türkiye)
Teva Investigational Site 5803
Dnipropetrovsk, , Ukraine
Teva Investigational Site 5802
Kyiv, , Ukraine
Teva Investigational Site 5804
Kyiv, , Ukraine
Teva Investigational Site 5800
Lviv, , Ukraine
Teva Investigational Site 5801
Vinnytsia, , Ukraine
Teva Investigational Site 3425
Liverpool, , United Kingdom
Teva Investigational Site 3424
London, , United Kingdom
Teva Investigational Site 3422
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2009-012989-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS-LAQ-301E
Identifier Type: -
Identifier Source: org_study_id