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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,047
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: Day 1 up to 7.13 years
Participants With Potentially Clinically Significant Abnormal Vital Signs
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,
Time frame: Baseline (Day 0 for extension), Day 1 up to 7.13 years
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
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=potassium
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Teva Investigational Site 1267
Homewood, Alabama, United States
Teva Investigational Site 1237
Phoenix, Arizona, United States
Teva Investigational Site 1279
Phoenix, Arizona, United States
Teva Investigational Site 1276
Tucson, Arizona, United States
Teva Investigational Site 1272
Pasadena, California, United States
Teva Investigational Site 1238
Sacramento, California, United States
Teva Investigational Site 1280
Aurora, Colorado, United States
Teva Investigational Site 1282
Sarasota, Florida, United States
Teva Investigational Site 1275
Atlanta, Georgia, United States
Teva Investigational Site 1250
Peoria, Illinois, United States
...and 134 more locations
Time frame: Baseline (Day 0), Day 1 to 7.13 years
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
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.
Time frame: Baseline (Day 0), Day 1 to 7.13 years
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
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)
Time frame: Baseline (Day 0), Day 1 to 7.13 years