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

December 7, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1047

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Laquinimod
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 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.
Day 1 up to 7.13 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Potentially Clinically Significant Abnormal Vital Signs
Time Frame: 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,
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
Time Frame: 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=potassium
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
Time Frame: 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.
Baseline (Day 0), Day 1 to 7.13 years
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Time Frame: 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)
Baseline (Day 0), Day 1 to 7.13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Principal Investigator: Prof. Timothy Vollmer, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2010

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-LAQ-302E
  • 2009-015815-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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