A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
- Registration Number
- NCT01047319
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 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
- 1047
- Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 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-302E study.
- Premature discontinuation from the MS-LAQ-302 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-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E 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 Experimental: 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 7.13 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 Potentially Clinically Significant Abnormal Vital Signs Baseline (Day 0 for extension), Day 1 up to 7.13 years Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:
* Pulse rate: \>=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 mmHg
Note that the change is compared to baseline,Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study Baseline (Day 0), Day 1 to 7.13 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 Baseline (Day 0), Day 1 to 7.13 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 Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study Baseline (Day 0), Day 1 to 7.13 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 (144)
Teva Investigational Site 1267
🇺🇸Homewood, Alabama, United States
Teva Investigational Site 1275
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 1272
🇺🇸Pasadena, California, United States
Teva Investigational Site 1276
🇺🇸Tucson, Arizona, United States
Teva Investigational Site 1238
🇺🇸Sacramento, California, United States
Teva Investigational Site 1282
🇺🇸Sarasota, Florida, United States
Teva Investigational Site 1280
🇺🇸Aurora, Colorado, United States
Teva Investigational Site 1250
🇺🇸Peoria, Illinois, United States
Teva Investigational Site 1263
🇺🇸Shreveport, Louisiana, United States
Teva Investigational Site 1269
🇺🇸Baltimore, Maryland, United States
Teva Investigational Site 1273
🇺🇸Albany, New York, United States
Teva Investigational Site 1264
🇺🇸Amherst, New York, United States
Teva Investigational Site 1261
🇺🇸Akron, Ohio, United States
Teva Investigational Site 1245
🇺🇸Cleveland, Ohio, United States
Teva Investigational Site 1247
🇺🇸Columbus, Ohio, United States
Teva Investigational Site 1270
🇺🇸Roanoke, Virginia, United States
Teva Investigational Site 1253
🇺🇸Tacoma, Washington, United States
Teva Investigational Site 5915
🇧🇬Pleven, Bulgaria
Teva Investigational Site 5917
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 5913
🇧🇬Varna, Bulgaria
Teva Investigational Site 5920
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5910
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5909
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5912
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5908
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5918
🇧🇬Stara Zagora, Bulgaria
Teva Investigational Site 5911
🇧🇬Sofia, Bulgaria
Teva Investigational Site 6003
🇭🇷Osijek, Croatia
Teva Investigational Site 5419
🇨🇿Olomouc, Czechia
Teva Investigational Site 6005
🇭🇷Varazdin, Croatia
Teva Investigational Site 6006
🇭🇷Zagreb, Croatia
Teva Investigational Site 6002
🇭🇷Zagreb, Croatia
Teva Investigational Site 5421
🇨🇿Teplice, Czechia
Teva Investigational Site 5418
🇨🇿Praha 2, Czechia
Teva Investigational Site 5420
🇨🇿Praha 5- Motol, Czechia
Teva Investigational Site 5508
🇪🇪Kohtla-Jarve, Estonia
Teva Investigational Site 8102
🇬🇪Tbilisi, Georgia
Teva Investigational Site 5509
🇪🇪Tartu, Estonia
Teva Investigational Site 8103
🇬🇪Tbilisi, Georgia
Teva Investigational Site 6400
🇩🇪Ulm, Germany
Teva Investigational Site 8104
🇬🇪Tbilisi, Georgia
Teva Investigational Site 8041
🇮🇱Jerusalem, Israel
Teva Investigational Site 6402
🇩🇪Berlin, Germany
Teva Investigational Site 6703
🇩🇪Berlin, Germany
Teva Investigational Site 8040
🇮🇱Ramat Gan, Israel
Teva Investigational Site 3056
🇮🇹Bologna, Italy
Teva Investigational Site 3061
🇮🇹Empoli, Italy
Teva Investigational Site 3053
🇮🇹Cefalu, Italy
Teva Investigational Site 3049
🇮🇹Firenze, Italy
Teva Investigational Site 3050
🇮🇹Rome, Italy
Teva Investigational Site 3055
🇮🇹Napoli, Italy
Teva Investigational Site 3052
🇮🇹Rome, Italy
Teva Investigational Site 5707
🇱🇹Siauliai, Lithuania
Teva Investigational Site 6500
🇲🇰Skopje, North Macedonia
Teva Investigational Site 6501
🇲🇰Skopje, North Macedonia
Teva Investigational Site 6502
🇲🇰Skopje, North Macedonia
Teva Investigational Site 5338
🇵🇱Gdansk, Poland
Teva Investigational Site 5329
🇵🇱Gdansk, Poland
Teva Investigational Site 6602
🇵🇱Gorzow Wielkopolski, Poland
Teva Investigational Site 5333
🇵🇱Grodzisk Mazowiecki, Poland
Teva Investigational Site 5339
🇵🇱Katowice, Poland
Teva Investigational Site 5332
🇵🇱Koscierzyna, Poland
Teva Investigational Site 6603
🇵🇱Kielce, Poland
Teva Investigational Site 5345
🇵🇱Krakow, Poland
Teva Investigational Site 5328
🇵🇱Lodz, Poland
Teva Investigational Site 5330
🇵🇱Olsztyn, Poland
Teva Investigational Site 5340
🇵🇱Warszawa, Poland
Teva Investigational Site 5235
🇷🇴Balotesti, Romania
Teva Investigational Site 5335
🇵🇱Wroclaw, Poland
Teva Investigational Site 5218
🇷🇴Bucharest, Romania
Teva Investigational Site 5214
🇷🇴Bucuresti, Romania
Teva Investigational Site 5213
🇷🇴Bucuresti, Romania
Teva Investigational Site 5217
🇷🇴Constanta, Romania
Teva Investigational Site 5219
🇷🇴Sibiu, Romania
Teva Investigational Site 5216
🇷🇴Iasi, Romania
Teva Investigational Site 5043
🇷🇺Barnaul, Russian Federation
Teva Investigational Site 5041
🇷🇺Moscow, Russian Federation
Teva Investigational Site 5038
🇷🇺Novosibirsk, Russian Federation
Teva Investigational Site 5037
🇷🇺Samara, Russian Federation
Teva Investigational Site 5035
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 5036
🇷🇺St. Petersburg, Russian Federation
Teva Investigational Site 5034
🇷🇺St. Petersburg, Russian Federation
Teva Investigational Site 5044
🇷🇺Ufa, Russian Federation
Teva Investigational Site 6200
🇸🇰Bratislava, Slovakia
Teva Investigational Site 6201
🇸🇰Bratislava, Slovakia
Teva Investigational Site 6202
🇸🇰Nitra, Slovakia
Teva Investigational Site 9007
🇿🇦Bloemfontein, South Africa
Teva Investigational Site 9001
🇿🇦Cape Town, South Africa
Teva Investigational Site 9004
🇿🇦Johannesburg, South Africa
Teva Investigational Site 9003
🇿🇦Parktown- Johannesburg, South Africa
Teva Investigational Site 9008
🇿🇦Pietermaritzburg, South Africa
Teva Investigational Site 9005
🇿🇦Pretoria, South Africa
Teva Investigational Site 9006
🇿🇦Rosebank, South Africa
Teva Investigational Site 3147
🇪🇸Barcelona, Spain
Teva Investigational Site 3154
🇪🇸Figueres-Girona, Spain
Teva Investigational Site 3149
🇪🇸L'Hospitalet de Llobregat, Spain
Teva Investigational Site 3152
🇪🇸Madrid, Spain
Teva Investigational Site 3151
🇪🇸Malaga, Spain
Teva Investigational Site 6503
🇺🇦Chernihiv, Ukraine
Teva Investigational Site 5823
🇺🇦Chernivtsi, Ukraine
Teva Investigational Site 5812
🇺🇦Donetsk, Ukraine
Teva Investigational Site 5811
🇺🇦Dnipropetrovsk, Ukraine
Teva Investigational Site 3153
🇪🇸Tortosa-Tarragona, Spain
Teva Investigational Site 3148
🇪🇸Sevilla, Spain
Teva Investigational Site 5814
🇺🇦Ivano-Frankivsk, Ukraine
Teva Investigational Site 5818
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 5815
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 5809
🇺🇦Lviv, Ukraine
Teva Investigational Site 5820
🇺🇦Odessa, Ukraine
Teva Investigational Site 5821
🇺🇦Poltava, Ukraine
Teva Investigational Site 5810
🇺🇦Vinnytsya, Ukraine
Teva Investigational Site 5819
🇺🇦Zaporizhzhya, Ukraine
Teva Investigational Site 5816
🇺🇦Zaporizhzhya, Ukraine
Teva Investigational Site 1260
🇺🇸Indianapolis, Indiana, United States
Teva Investigational Site 3054
🇮🇹Chieti, Italy
Teva Investigational Site 3048
🇮🇹Rome, Italy
Teva Investigational Site 1237
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 1279
🇺🇸Phoenix, Arizona, United States
Teva Investigational Site 1244
🇺🇸Portland, Oregon, United States
Teva Investigational Site 1281
🇺🇸Nashville, Tennessee, United States
Teva Investigational Site 4212
🇧🇬Ruse, Bulgaria
Teva Investigational Site 5916
🇧🇬Shumen, Bulgaria
Teva Investigational Site 5919
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5914
🇧🇬Pleven, Bulgaria
Teva Investigational Site 6001
🇭🇷Zagreb, Croatia
Teva Investigational Site 5708
🇱🇹Kaunas, Lithuania
Teva Investigational Site 5907
🇧🇬Sofia, Bulgaria
Teva Investigational Site 5337
🇵🇱Bialystok, Poland
Teva Investigational Site 4213
🇵🇱Konskie, Poland
Teva Investigational Site 5906
🇧🇬Sofia, Bulgaria
Teva Investigational Site 4211
🇧🇬Veliko Tarnovo, Bulgaria
Teva Investigational Site 5507
🇪🇪Tallinn, Estonia
Teva Investigational Site 5334
🇵🇱Katowice, Poland
Teva Investigational Site 8209
🇷🇴Craiova, Romania
Teva Investigational Site 5033
🇷🇺Moscow, Russian Federation
Teva Investigational Site 5331
🇵🇱Szczecin, Poland
Teva Investigational Site 5336
🇵🇱Warsaw, Poland
Teva Investigational Site 5341
🇵🇱Warszawa, Poland
Teva Investigational Site 5822
🇺🇦Kyiv, Ukraine
Teva Investigational Site 5215
🇷🇴Cluj-Napoca, Romania
Teva Investigational Site 5042
🇷🇺Novosibirsk, Russian Federation
Teva Investigational Site 6203
🇸🇰Zilina, Slovakia
Teva Investigational Site 5817
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 5032
🇷🇺Moscow, Russian Federation