A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
- Registration Number
- NCT00988052
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 839
- Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
- 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..
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.
- Premature discontinuation from the MS-LAQ-301 study, for any reason.
- Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
- 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.
- Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Laquinimod Laquinimod One capsule containing 0.6 mg laquinimod to be administered orally once daily.
- Primary Outcome Measures
Name Time Method Participants With Treatment-Emergent Adverse Events (TEAEs) Day 1 up to 7.64 years A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.
- Secondary Outcome Measures
Name Time Method Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study Day 1 up to 7.64 years Counts include two conditions:
* a change from High / Non-PCS at baseline to Low PCS at any point during the study
* a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassiumParticipants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study Day 1 up to 7.64 years Shifts are presented as Baseline finding / Worse finding at anytime during the study.
Categories for findings are:
* normal
* abnormal, not clinically significant (Not CS)
* abnormal, clinically significant (CS)Participants With Potentially Clinically Significant Abnormal Vital Signs Day 1 up to 7.64 years Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:
* Pulse rate low: \<=45 and decrease \>=30 beats/minute
* Pulse rate high: \>=120 and increase \>=30 beats/minute
* Systolic blood pressure low: \<=90 and decrease \>=30 mmHg
* Systolic blood pressure high: \>=180 and increase \>=30 mmHg
* Diastolic blood pressure low: \<=50 and decrease \>=20 mmHg
* Diastolic blood pressure high: \>=100 and increase \>=20 mmHgParticipants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study Day 1 up to 7.64 years Counts include two conditions:
* a change from High / Non-PCS at baseline to Low PCS at any point during the study
* a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count.
Trial Locations
- Locations (135)
Teva Investigational Site 5904
🇧🇬Sofia, Bulgaria
Teva Investigational Site 1132
🇨🇦Bedford, Nova Scotia, Canada
Teva Investigational Site 8100
🇬🇪Tbilisi, Georgia
Teva Investigational Site 5900
🇧🇬Sofia, Bulgaria
Teva Investigational Site 1129
🇨🇦Montreal, Quebec, Canada
Teva Investigational Site 5209
🇷🇴Timisoara, Romania
Teva Investigational Site 3303
🇦🇹Linz, Austria
Teva Investigational Site 5905
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5027
🇷🇺Novosibirsk, Russian Federation
Teva Investigational Site 5026
🇷🇺St.Petersburg, Russian Federation
Teva Investigational Site 5803
🇺🇦Dnipropetrovsk, Ukraine
Teva Investigational Site 5505
🇪🇪Tartu, Estonia
Teva Investigational Site 5318
🇵🇱Kielce, Poland
Teva Investigational Site 5210
🇷🇴Cluj-Napoca, Romania
Teva Investigational Site 5030
🇷🇺Perm, Russian Federation
Teva Investigational Site 5023
🇷🇺St. Petersburg, Russian Federation
Teva Investigational Site 5800
🇺🇦Lviv, Ukraine
Teva Investigational Site 5025
🇷🇺St. Petersburg, Russian Federation
Teva Investigational Site 6102
🇷🇸Nis, Serbia
Teva Investigational Site 5021
🇷🇺Moscow, Russian Federation
Teva Investigational Site 3045
🇮🇹Fidenza, Italy
Teva Investigational Site 555
🇮🇹Milano, Italy
Teva Investigational Site 3039
🇮🇹Milano, Italy
Teva Investigational Site 3041
🇮🇹Palermo, Italy
Teva Investigational Site 3040
🇮🇹Rome, Italy
Teva Investigational Site 3137
🇪🇸Murcia, Spain
Teva Investigational Site 3140
🇪🇸Beade-Pontevedra, Spain
Teva Investigational Site 1101
🇺🇸Lexington, Kentucky, United States
Teva Investigational Site 1092
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 3300
🇦🇹Klagenfurt, Austria
Teva Investigational Site 3302
🇦🇹Sankt Polten, Austria
Teva Investigational Site 5903
🇧🇬Sofia, Bulgaria
Teva Investigational Site 3526
🇫🇷Clermont-Ferrand Cedex 1, France
Teva Investigational Site 3528
🇫🇷Marseille Cedex 5, France
Teva Investigational Site 1130
🇨🇦Greenfield Park, Quebec, Canada
Teva Investigational Site 1081
🇺🇸Fort Wayne, Indiana, United States
Teva Investigational Site 8101
🇬🇪Tbilisi, Georgia
Teva Investigational Site 3529
🇫🇷Rennes Cedex 9, France
Teva Investigational Site 1078
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 5902
🇧🇬Varna, Bulgaria
Teva Investigational Site 1128
🇨🇦Ottawa, Ontario, Canada
Teva Investigational Site 1084
🇺🇸Dayton, Ohio, United States
Teva Investigational Site 1126
🇨🇦London, Ontario, Canada
Teva Investigational Site 3527
🇫🇷Bron Cedex, France
Teva Investigational Site 5315
🇵🇱Lodz, Poland
Teva Investigational Site 5212
🇷🇴Constanta, Romania
Teva Investigational Site 3524
🇫🇷Lille Cedex, France
Teva Investigational Site 5416
🇨🇿Ostrava - poruba, Czechia
Teva Investigational Site 1134
🇨🇦Toronto, Ontario, Canada
Teva Investigational Site 5504
🇪🇪Tallinn, Estonia
Teva Investigational Site 1131
🇨🇦Sherbrooke, Quebec, Canada
Teva Investigational Site 1086
🇺🇸Kansas City, Kansas, United States
Teva Investigational Site 1096
🇺🇸Farmington Hills, Michigan, United States
Teva Investigational Site 3044
🇮🇹Catania, Italy
Teva Investigational Site 8031
🇮🇱Haifa, Israel
Teva Investigational Site 8030
🇮🇱Jerusalem, Israel
Teva Investigational Site 3810
🇳🇱Nieuwegein, Netherlands
Teva Investigational Site 3809
🇳🇱Nijmegen, Netherlands
Teva Investigational Site 5316
🇵🇱Katowice, Poland
Teva Investigational Site 5319
🇵🇱Konskie, Poland
Teva Investigational Site 5211
🇷🇴Targu-Mures, Romania
Teva Investigational Site 3247
🇩🇪Bayreuth, Germany
Teva Investigational Site 5116
🇭🇺Miskolc, Hungary
Teva Investigational Site 3133
🇪🇸Madrid, Spain
Teva Investigational Site 5117
🇭🇺Veszprem, Hungary
Teva Investigational Site 8033
🇮🇱Ramat Gan, Israel
Teva Investigational Site 8032
🇮🇱Tel Aviv, Israel
Teva Investigational Site 3042
🇮🇹Gallarate, Italy
Teva Investigational Site 5029
🇷🇺Ekaterinburg, Russian Federation
Teva Investigational Site 3046
🇮🇹Grosseto, Italy
Teva Investigational Site 4204
🇸🇪Stockholm, Sweden
Teva Investigational Site 4205
🇸🇪Stockholm, Sweden
Teva Investigational Site 8201
🇹🇷Izmir, Turkey
Teva Investigational Site 3238
🇩🇪Berlin, Germany
Teva Investigational Site 3246
🇩🇪Hamburg, Germany
Teva Investigational Site 5115
🇭🇺Budapest, Hungary
Teva Investigational Site 3241
🇩🇪Berlin, Germany
Teva Investigational Site 3248
🇩🇪Bochum, Germany
Teva Investigational Site 3242
🇩🇪Erbach, Germany
Teva Investigational Site 3239
🇩🇪Hannover, Germany
Teva Investigational Site 3245
🇩🇪Dresden, Germany
Teva Investigational Site 5114
🇭🇺Debrecen, Hungary
Teva Investigational Site 5704
🇱🇹Kaunas, Lithuania
Teva Investigational Site 5705
🇱🇹Siauliai, Lithuania
Teva Investigational Site 5208
🇷🇴Bucharest, Romania
Teva Investigational Site 3038
🇮🇹Milano, Italy
Teva Investigational Site 5320
🇵🇱Gorzow Wielkopolski, Poland
Teva Investigational Site 5317
🇵🇱Krakow, Poland
Teva Investigational Site 3134
🇪🇸Barcelona, Spain
Teva Investigational Site 3144
🇪🇸Barcelona, Spain
Teva Investigational Site 5024
🇷🇺St. Petersburg, Russian Federation
Teva Investigational Site 6100
🇷🇸Belgrade, Serbia
Teva Investigational Site 3132
🇪🇸Barcelona, Spain
Teva Investigational Site 4206
🇸🇪Stockholm, Sweden
Teva Investigational Site 3142
🇪🇸Getafe, Spain
Teva Investigational Site 3139
🇪🇸Santiago de Compostela, Spain
Teva Investigational Site 3143
🇪🇸Valencia, Spain
Teva Investigational Site 3425
🇬🇧Liverpool, United Kingdom
Teva Investigational Site 3424
🇬🇧London, United Kingdom
Teva Investigational Site 5802
🇺🇦Kyiv, Ukraine
Teva Investigational Site 3422
🇬🇧Sheffield, United Kingdom
Teva Investigational Site 3237
🇩🇪Emden, Germany
Teva Investigational Site 3240
🇩🇪Erfurt, Germany
Teva Investigational Site 3249
🇩🇪Freiburg, Germany
Teva Investigational Site 3236
🇩🇪Hamburg, Germany
Teva Investigational Site 3243
🇩🇪Heidelberg, Germany
Teva Investigational Site 3244
🇩🇪Ulm, Germany
Teva Investigational Site 1093
🇺🇸Minneapolis, Minnesota, United States
Teva Investigational Site 1100
🇺🇸Hershey, Pennsylvania, United States
Teva Investigational Site 3251
🇩🇪Munster, Germany
Teva Investigational Site 3250
🇩🇪Trier, Germany
Teva Investigational Site 1088
🇺🇸Fort Collins, Colorado, United States
Teva Investigational Site 1090
🇺🇸Centennial, Colorado, United States
Teva Investigational Site 1083
🇺🇸Des Moines, Iowa, United States
Teva Investigational Site 1102
🇺🇸Northbrook, Illinois, United States
Teva Investigational Site 1076
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 1073
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 1098
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 1082
🇺🇸New York, New York, United States
Teva Investigational Site 5901
🇧🇬Pleven, Bulgaria
Teva Investigational Site 1097
🇺🇸Fargo, North Dakota, United States
Teva Investigational Site 1075
🇺🇸Lubbock, Texas, United States
Teva Investigational Site 1085
🇺🇸Milwaukee, Wisconsin, United States
Teva Investigational Site 5417
🇨🇿Olomouc, Czechia
Teva Investigational Site 3525
🇫🇷Besancon, France
Teva Investigational Site 5322
🇵🇱Czestochowa, Poland
Teva Investigational Site 5325
🇵🇱Warszawa, Poland
Teva Investigational Site 5028
🇷🇺Nizhny Novgorod, Russian Federation
Teva Investigational Site 5022
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 3146
🇪🇸Madrid, Spain
Teva Investigational Site 3135
🇪🇸Lleida, Spain
Teva Investigational Site 3138
🇪🇸Pontevedra, Spain
Teva Investigational Site 3136
🇪🇸Salt, Spain
Teva Investigational Site 5804
🇺🇦Kyiv, Ukraine
Teva Investigational Site 5801
🇺🇦Vinnytsya, Ukraine