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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

Primary Purpose

Relapsing Multiple Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Laquinimod
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring Relapsing Multiple Sclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 protocol.
  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-302E study.

Exclusion Criteria:

  1. Premature discontinuation from the MS-LAQ-302 study, for any reason.
  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-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.
  4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).

Sites / Locations

  • Teva Investigational Site 1267
  • Teva Investigational Site 1237
  • Teva Investigational Site 1279
  • Teva Investigational Site 1276
  • Teva Investigational Site 1272
  • Teva Investigational Site 1238
  • Teva Investigational Site 1280
  • Teva Investigational Site 1282
  • Teva Investigational Site 1275
  • Teva Investigational Site 1250
  • Teva Investigational Site 1260
  • Teva Investigational Site 1263
  • Teva Investigational Site 1269
  • Teva Investigational Site 1273
  • Teva Investigational Site 1264
  • Teva Investigational Site 1261
  • Teva Investigational Site 1245
  • Teva Investigational Site 1247
  • Teva Investigational Site 1244
  • Teva Investigational Site 1281
  • Teva Investigational Site 1270
  • Teva Investigational Site 1253
  • Teva Investigational Site 5914
  • Teva Investigational Site 5915
  • Teva Investigational Site 5917
  • Teva Investigational Site 4212
  • Teva Investigational Site 5916
  • Teva Investigational Site 5920
  • Teva Investigational Site 5907
  • Teva Investigational Site 5910
  • Teva Investigational Site 5909
  • Teva Investigational Site 5919
  • Teva Investigational Site 5906
  • Teva Investigational Site 5908
  • Teva Investigational Site 5911
  • Teva Investigational Site 5912
  • Teva Investigational Site 5918
  • Teva Investigational Site 5913
  • Teva Investigational Site 4211
  • Teva Investigational Site 6003
  • Teva Investigational Site 6005
  • Teva Investigational Site 6001
  • Teva Investigational Site 6002
  • Teva Investigational Site 6006
  • Teva Investigational Site 5419
  • Teva Investigational Site 5418
  • Teva Investigational Site 5420
  • Teva Investigational Site 5421
  • Teva Investigational Site 5508
  • Teva Investigational Site 5507
  • Teva Investigational Site 5509
  • Teva Investigational Site 8102
  • Teva Investigational Site 8104
  • Teva Investigational Site 8103
  • Teva Investigational Site 6703
  • Teva Investigational Site 6402
  • Teva Investigational Site 6400
  • Teva Investigational Site 8041
  • Teva Investigational Site 8040
  • Teva Investigational Site 3056
  • Teva Investigational Site 3053
  • Teva Investigational Site 3054
  • Teva Investigational Site 3061
  • Teva Investigational Site 3049
  • Teva Investigational Site 3055
  • Teva Investigational Site 3048
  • Teva Investigational Site 3052
  • Teva Investigational Site 3050
  • Teva Investigational Site 5708
  • Teva Investigational Site 5707
  • Teva Investigational Site 6500
  • Teva Investigational Site 6501
  • Teva Investigational Site 6502
  • Teva Investigational Site 5337
  • Teva Investigational Site 5329
  • Teva Investigational Site 5338
  • Teva Investigational Site 6602
  • Teva Investigational Site 5333
  • Teva Investigational Site 5334
  • Teva Investigational Site 5339
  • Teva Investigational Site 6603
  • Teva Investigational Site 4213
  • Teva Investigational Site 5332
  • Teva Investigational Site 5345
  • Teva Investigational Site 5328
  • Teva Investigational Site 5330
  • Teva Investigational Site 5331
  • Teva Investigational Site 5336
  • Teva Investigational Site 5340
  • Teva Investigational Site 5341
  • Teva Investigational Site 5335
  • Teva Investigational Site 5235
  • Teva Investigational Site 5218
  • Teva Investigational Site 5214
  • Teva Investigational Site 5213
  • Teva Investigational Site 5215
  • Teva Investigational Site 5217
  • Teva Investigational Site 8209
  • Teva Investigational Site 5216
  • Teva Investigational Site 5219
  • Teva Investigational Site 5043
  • Teva Investigational Site 5033
  • Teva Investigational Site 5041
  • Teva Investigational Site 5032
  • Teva Investigational Site 5038
  • Teva Investigational Site 5042
  • Teva Investigational Site 5035
  • Teva Investigational Site 5037
  • Teva Investigational Site 5036
  • Teva Investigational Site 5034
  • Teva Investigational Site 5044
  • Teva Investigational Site 6200
  • Teva Investigational Site 6201
  • Teva Investigational Site 6202
  • Teva Investigational Site 6203
  • Teva Investigational Site 9007
  • Teva Investigational Site 9001
  • Teva Investigational Site 9004
  • Teva Investigational Site 9003
  • Teva Investigational Site 9008
  • Teva Investigational Site 9005
  • Teva Investigational Site 9006
  • Teva Investigational Site 3147
  • Teva Investigational Site 3154
  • Teva Investigational Site 3149
  • Teva Investigational Site 3152
  • Teva Investigational Site 3151
  • Teva Investigational Site 3148
  • Teva Investigational Site 3153
  • Teva Investigational Site 6503
  • Teva Investigational Site 5823
  • Teva Investigational Site 5811
  • Teva Investigational Site 5812
  • Teva Investigational Site 5814
  • Teva Investigational Site 5817
  • Teva Investigational Site 5818
  • Teva Investigational Site 5815
  • Teva Investigational Site 5822
  • Teva Investigational Site 5809
  • Teva Investigational Site 5820
  • Teva Investigational Site 5821
  • Teva Investigational Site 5810
  • Teva Investigational Site 5819
  • Teva Investigational Site 5816

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Laquinimod

Arm Description

One capsule containing 0.6 mg laquinimod to be administered orally once daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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,
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
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.
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)

Full Information

First Posted
January 8, 2010
Last Updated
December 7, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01047319
Brief Title
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
Official Title
A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, 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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose
Study Start Date
May 27, 2010 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1047 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Laquinimod
Arm Type
Experimental
Arm Description
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Laquinimod
Intervention Description
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Primary Outcome Measure Information:
Title
Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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
Secondary Outcome Measure Information:
Title
Participants With Potentially Clinically Significant Abnormal Vital Signs
Description
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
Title
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Description
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
Title
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Description
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
Title
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Timothy Vollmer, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teva Investigational Site 1267
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Teva Investigational Site 1237
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Teva Investigational Site 1279
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Teva Investigational Site 1276
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Teva Investigational Site 1272
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Teva Investigational Site 1238
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Teva Investigational Site 1280
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Teva Investigational Site 1282
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Teva Investigational Site 1275
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Teva Investigational Site 1250
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Teva Investigational Site 1260
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Teva Investigational Site 1263
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Teva Investigational Site 1269
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Teva Investigational Site 1273
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Teva Investigational Site 1264
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Teva Investigational Site 1261
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Teva Investigational Site 1245
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5244
Country
United States
Facility Name
Teva Investigational Site 1247
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Teva Investigational Site 1244
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Teva Investigational Site 1281
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Teva Investigational Site 1270
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Teva Investigational Site 1253
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Teva Investigational Site 5914
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Teva Investigational Site 5915
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Teva Investigational Site 5917
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Teva Investigational Site 4212
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Teva Investigational Site 5916
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Teva Investigational Site 5920
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Teva Investigational Site 5907
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Teva Investigational Site 5910
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Teva Investigational Site 5909
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Teva Investigational Site 5919
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Teva Investigational Site 5906
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Teva Investigational Site 5908
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Teva Investigational Site 5911
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Teva Investigational Site 5912
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Teva Investigational Site 5918
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Teva Investigational Site 5913
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Teva Investigational Site 4211
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Teva Investigational Site 6003
City
Osijek
ZIP/Postal Code
31 000
Country
Croatia
Facility Name
Teva Investigational Site 6005
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Teva Investigational Site 6001
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Teva Investigational Site 6002
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Teva Investigational Site 6006
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Teva Investigational Site 5419
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Teva Investigational Site 5418
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Teva Investigational Site 5420
City
Praha 5- Motol
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Teva Investigational Site 5421
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Teva Investigational Site 5508
City
Kohtla-Jarve
ZIP/Postal Code
31025
Country
Estonia
Facility Name
Teva Investigational Site 5507
City
Tallinn
ZIP/Postal Code
EE-10617
Country
Estonia
Facility Name
Teva Investigational Site 5509
City
Tartu
ZIP/Postal Code
EE-51014
Country
Estonia
Facility Name
Teva Investigational Site 8102
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Teva Investigational Site 8104
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Teva Investigational Site 8103
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Teva Investigational Site 6703
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Teva Investigational Site 6402
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Teva Investigational Site 6400
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Teva Investigational Site 8041
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Teva Investigational Site 8040
City
Ramat Gan
ZIP/Postal Code
5262160
Country
Israel
Facility Name
Teva Investigational Site 3056
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Teva Investigational Site 3053
City
Cefalu
ZIP/Postal Code
90015
Country
Italy
Facility Name
Teva Investigational Site 3054
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Teva Investigational Site 3061
City
Empoli
ZIP/Postal Code
50053
Country
Italy
Facility Name
Teva Investigational Site 3049
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Teva Investigational Site 3055
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Teva Investigational Site 3048
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Teva Investigational Site 3052
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Teva Investigational Site 3050
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Teva Investigational Site 5708
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Teva Investigational Site 5707
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Teva Investigational Site 6500
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Teva Investigational Site 6501
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Teva Investigational Site 6502
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Teva Investigational Site 5337
City
Bialystok
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Teva Investigational Site 5329
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Teva Investigational Site 5338
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Teva Investigational Site 6602
City
Gorzow Wielkopolski
ZIP/Postal Code
66-400
Country
Poland
Facility Name
Teva Investigational Site 5333
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Teva Investigational Site 5334
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Facility Name
Teva Investigational Site 5339
City
Katowice
ZIP/Postal Code
40-684
Country
Poland
Facility Name
Teva Investigational Site 6603
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
Teva Investigational Site 4213
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
Teva Investigational Site 5332
City
Koscierzyna
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Teva Investigational Site 5345
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Teva Investigational Site 5328
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Teva Investigational Site 5330
City
Olsztyn
ZIP/Postal Code
10-560
Country
Poland
Facility Name
Teva Investigational Site 5331
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Teva Investigational Site 5336
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Teva Investigational Site 5340
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Teva Investigational Site 5341
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Teva Investigational Site 5335
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Teva Investigational Site 5235
City
Balotesti
ZIP/Postal Code
077015
Country
Romania
Facility Name
Teva Investigational Site 5218
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Facility Name
Teva Investigational Site 5214
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Teva Investigational Site 5213
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Teva Investigational Site 5215
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Teva Investigational Site 5217
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Teva Investigational Site 8209
City
Craiova
ZIP/Postal Code
200515
Country
Romania
Facility Name
Teva Investigational Site 5216
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
Teva Investigational Site 5219
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Teva Investigational Site 5043
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Teva Investigational Site 5033
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
Teva Investigational Site 5041
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Teva Investigational Site 5032
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Teva Investigational Site 5038
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Teva Investigational Site 5042
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Teva Investigational Site 5035
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Teva Investigational Site 5037
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Teva Investigational Site 5036
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Teva Investigational Site 5034
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Teva Investigational Site 5044
City
Ufa
ZIP/Postal Code
450007
Country
Russian Federation
Facility Name
Teva Investigational Site 6200
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Teva Investigational Site 6201
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Teva Investigational Site 6202
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Teva Investigational Site 6203
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Teva Investigational Site 9007
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Teva Investigational Site 9001
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Teva Investigational Site 9004
City
Johannesburg
ZIP/Postal Code
2157
Country
South Africa
Facility Name
Teva Investigational Site 9003
City
Parktown- Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Teva Investigational Site 9008
City
Pietermaritzburg
ZIP/Postal Code
3201
Country
South Africa
Facility Name
Teva Investigational Site 9005
City
Pretoria
ZIP/Postal Code
0041
Country
South Africa
Facility Name
Teva Investigational Site 9006
City
Rosebank
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Teva Investigational Site 3147
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Teva Investigational Site 3154
City
Figueres-Girona
ZIP/Postal Code
17600
Country
Spain
Facility Name
Teva Investigational Site 3149
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Teva Investigational Site 3152
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Teva Investigational Site 3151
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Teva Investigational Site 3148
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Teva Investigational Site 3153
City
Tortosa-Tarragona
ZIP/Postal Code
43500
Country
Spain
Facility Name
Teva Investigational Site 6503
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Teva Investigational Site 5823
City
Chernivtsi
ZIP/Postal Code
58018
Country
Ukraine
Facility Name
Teva Investigational Site 5811
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Teva Investigational Site 5812
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
Teva Investigational Site 5814
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Teva Investigational Site 5817
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Teva Investigational Site 5818
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Teva Investigational Site 5815
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Teva Investigational Site 5822
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Teva Investigational Site 5809
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Teva Investigational Site 5820
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Teva Investigational Site 5821
City
Poltava
ZIP/Postal Code
36024
Country
Ukraine
Facility Name
Teva Investigational Site 5810
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Teva Investigational Site 5819
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Teva Investigational Site 5816
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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