A Phase 3 interventional study of Laquinimod in Relapsing Multiple Sclerosis, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Terminated at 144 sites in 18 countries. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 1,047 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Drug: Laquinimod
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
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
All participants who completed the full duration of the double-blind BRAVO study (study MS-LAQ-302) were eligible to enter into Study MS-LAQ-302E. Of the 1090 participants who completed MS-LAQ-302, 1047 opted to continue into the open-label extension study.
| Milestone | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| Started | 345 | 350 | 352 |
| Completed | 0 | 0 | 0 |
| Not completed | 345 | 350 | 352 |
| Withdrew: Teva requested participant withdrawal | 3 | 0 | 1 |
| Withdrew: Protocol violation | 3 | 2 | 4 |
| Withdrew: Lack of efficacy | 4 | 3 | 3 |
| Withdrew: Death | 5 | 1 | 5 |
| Withdrew: Pregnancy | 13 | 8 | 8 |
| Withdrew: Physician decision | 12 | 9 | 10 |
| Withdrew: Lost to follow-up | 14 | 10 | 10 |
| Withdrew: Adverse event | 16 | 27 | 21 |
| Withdrew: Withdrawal by subject | 77 | 75 | 87 |
| Withdrew: Study terminated by sponsor | 198 | 215 | 203 |
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.
| Participants | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| =>1 TEAE | 290 | 303 | 279 |
| =>1 Serious TEAE | 54 | 65 | 51 |
| =>1 Severe TEAE | 36 | 54 | 44 |
| =>1 TEAE causing discontinuation | 20 | 28 | 23 |
| =>1 TEAE of special interest | 66 | 64 | 73 |
| =>1 treatment-related TEAE | 66 | 76 | 96 |
| =>1 TEAE leading to death | 5 | 3 | 5 |
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 | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| Participants with at least one abnormality | 19 | 23 | 19 |
| Pulse rate - high | 2 | 0 | 0 |
| Systolic blood pressure - low | 4 | 7 | 9 |
| Systolic blood pressure - high | 0 | 2 | 0 |
| Diastolic blood pressure - low | 4 | 5 | 4 |
| Diastolic blood pressure - high | 9 | 10 | 7 |
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
| Participants | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| ALT - change from Low / Non-PCS to High PCS | 5 | 8 | 10 |
| Albumen - change from High / Non-PCS to Low PCS | 0 | 1 | 0 |
| ALP - change from Low / Non-PCS to High PCS | 0 | 2 | 0 |
| p-Amylase - change from Low / Non-PCS to High PCS | 5 | 1 | 2 |
| AST - change from Low / Non-PCS to High PCS | 3 | 2 | 5 |
| Bilirubin - change from Low / Non-PCS to High PCS | 2 | 3 | 2 |
| CRP - change from Low / Non-PCS to High PCS | 36 | 32 | 31 |
| Calcium - change from High / Non-PCS to Low PCS | 1 | 1 | 1 |
| Calcium - change from Low / Non-PCS to High PCS | 1 | 1 | 2 |
| CK - change from Low / Non-PCS to High PCS | 11 | 12 | 10 |
| CTN - change from Low / Non-PCS to High PCS | 1 | 1 | 0 |
| FIB - change from Low / Non-PCS to High PCS | 22 | 24 | 25 |
| GGT - change from Low / Non-PCS to High PCS | 16 | 22 | 18 |
| Glucose - change from High / Non-PCS to Low PCS | 12 | 16 | 11 |
| Glucose - change from Low / Non-PCS to High PCS | 4 | 5 | 2 |
| Phosphate-change from High / Non-PCS to Low PCS | 12 | 12 | 6 |
| Phosphate-change from Low / Non-PCS to High PCS | 17 | 18 | 16 |
| K - change from High / Non-PCS to Low PCS | 2 | 4 | 2 |
| K - change from Low / Non-PCS to High PCS | 46 | 39 | 38 |
| Sodium - change from High / Non-PCS to Low PCS | 4 | 2 | 3 |
| Sodium - change from Low / Non-PCS to High PCS | 21 | 16 | 17 |
| Urea - change from Low / Non-PCS to High PCS | 4 | 4 | 3 |
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.
| Participants | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| Hematocrit - change from High / Non-PCS to Low PCS | 30 | 25 | 21 |
| Hemoglobin -change from High / Non-PCS to Low PCS | 21 | 24 | 15 |
| Leukocytes - change from High / Non-PCS to Low PCS | 2 | 4 | 2 |
| Leukocytes - change from Low / Non-PCS to High PCS | 4 | 1 | 5 |
| Neutrophils - change from High/Non-PCS to Low PCS | 25 | 12 | 14 |
| Platelets - change from High / Non-PCS to Low PCS | 5 | 3 | 2 |
| Platelets - change from Low / Non-PCS to High PCS | 4 | 4 | 4 |
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 | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| Normal / Normal | 150 | 148 | 134 |
| Normal / Abnormal, Not CS | 109 | 125 | 119 |
| Normal / Abnormal, CS | 5 | 3 | 5 |
| Abnormal, Not CS / Normal | 5 | 7 | 20 |
| Abnormal, Not CS / Abnormal, Not CS | 67 | 62 | 64 |
| Abnormal, Not CS / Abnormal, CS | 4 | 0 | 2 |
| Abnormal, CS / Normal | 0 | 0 | 0 |
| Abnormal, CS / Abnormal, Not CS | 0 | 0 | 1 |
| Abnormal, CS / Abnormal, CS | 0 | 1 | 0 |
Collected over Day 1 up to 7.13 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early Laquinimod | 5/345 (1.4%) | 54/345 (15.7%) | 215/345 (62.3%) |
| Switch From Placebo | 3/350 (0.9%) | 65/350 (18.6%) | 205/350 (58.6%) |
| Switch From Avonex | 5/352 (1.4%) | 51/352 (14.5%) | 194/352 (55.1%) |
| Event | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/345 | 4/350 | 3/352 |
| EndometriosisReproductive system and breast disorders | 0/345 | 4/350 | 0/352 |
| Urinary tract infectionInfections and infestations | 3/345 | 1/350 | 2/352 |
| Trigeminal neuralgiaNervous system disorders | 0/345 | 3/350 | 1/352 |
| Cervical dysplasiaReproductive system and breast disorders | 0/345 | 3/350 | 0/352 |
| Myocardial infarctionCardiac disorders | 0/345 | 0/350 | 3/352 |
| Acute myocardial infarctionCardiac disorders | 2/345 | 0/350 | 2/352 |
| AppendicitisInfections and infestations | 2/345 | 0/350 | 1/352 |
| CystitisInfections and infestations | 2/345 | 0/350 | 0/352 |
| PeritonitisInfections and infestations | 2/345 | 1/350 | 1/352 |
| Event | Early Laquinimod | Switch From Placebo | Switch From Avonex |
|---|---|---|---|
| HeadacheNervous system disorders | 44/345 | 60/350 | 74/352 |
| NasopharyngitisInfections and infestations | 52/345 | 46/350 | 37/352 |
| Back painMusculoskeletal and connective tissue disorders | 49/345 | 49/350 | 50/352 |
| Upper respiratory tract infectionInfections and infestations | 36/345 | 36/350 | 28/352 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 21/345 | 23/350 | 28/352 |
| InfluenzaInfections and infestations | 27/345 | 25/350 | 22/352 |
| DepressionPsychiatric disorders | 26/345 | 20/350 | 17/352 |
| BronchitisInfections and infestations | 24/345 | 23/350 | 16/352 |
| AnaemiaBlood and lymphatic system disorders | 22/345 | 20/350 | 15/352 |
| Urinary tract infectionInfections and infestations | 22/345 | 18/350 | 17/352 |
Participants enrolled in the MS-LAQ-302 extension study.
| Age, Continuous(years) | Early Laquinimod | Switch From Placebo | Switch From Avonex | Total |
|---|---|---|---|---|
| Mean | 39.2 ± 9.16 | 40.1 ± 9.23 | 40.1 ± 9.34 | 39.8 ± 9.24 |
| Sex: Female, Male(Participants) | Early Laquinimod | Switch From Placebo | Switch From Avonex | Total |
|---|---|---|---|---|
| Female | 228 | 245 | 234 | 707 |
| Male | 117 | 105 | 118 | 340 |
| Race/Ethnicity, Customized(Participants) | Early Laquinimod | Switch From Placebo | Switch From Avonex | Total |
|---|---|---|---|---|
| Asian/Oriental | 1 | 0 | 1 | 2 |
| Black/African American | 2 | 2 | 2 | 6 |
| White | 338 | 346 | 348 | 1032 |
| Unknown | 2 | 2 | 0 | 4 |
| Other | 2 | 0 | 1 | 3 |
Showing the first 100 of 144 sites across 18 countries.
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Teva Branded Pharmaceutical Products R&D, Inc.