BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®) (BRAVO)

A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design

The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Placebo; Drug: Laquinimod; Drug: Avonex®

• Study Type: Interventional
• Enrollment (Actual): 1331
• Phase: Phase 3

Contacts and Locations

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
  • Split, Croatia, 21000
    • Teva Investigational Site 6004
  • 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
  • Brno, Czechia, 602 00
    • Teva Investigational Site 5422
  • 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
  • Bayreuth, Germany, 95445
    • Teva Investigational Site 6701
  • Berlin, Germany, 10117
    • Teva Investigational Site 6703
  • Berlin, Germany, 12203
    • Teva Investigational Site 6402
  • Berlin, Germany, 13088
    • Teva Investigational Site 6700
  • Dresden, Germany, 01307
    • Teva Investigational Site 6702
  • Hannover, Germany, 30559
    • Teva Investigational Site 6401
  • Munster, Germany, 48149
    • Teva Investigational Site 6403
  • Ulm, Germany, 89081
    • Teva Investigational Site 6400
• Israel
  • Haifa, Israel, 3436212
    • Teva Investigational Site 8043
  • Jerusalem, Israel, 9112001
    • Teva Investigational Site 8041
  • Ramat Gan, Israel, 5262160
    • Teva Investigational Site 8040
  • Ramat Gan, Israel, 5262160
    • Teva Investigational Site 8042
• Italy
  • Bologna, Italy, 40139
    • Teva Investigational Site 3056
  • Catania, Italy, 95122
    • Teva Investigational Site 3062
  • 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
  • Rome, Italy, 163
    • Teva Investigational Site 3060
  • Torino, Italy, 10126
    • Teva Investigational Site 3051
• Lithuania
  • Kaunas, Lithuania, 50009
    • Teva Investigational Site 5708
  • Siauliai, Lithuania, 76231
    • Teva Investigational Site 5707
• North Macedonia
  • Bitola, North Macedonia, 7000
    • Teva Investigational Site 6502
  • Skopje, North Macedonia, 1000
    • Teva Investigational Site 6500
  • Skopje, North Macedonia, 1000
    • Teva Investigational Site 6501
• 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, 40-635
    • Teva Investigational Site 5339
  • Katowice, Poland, 40-752
    • Teva Investigational Site 5334
  • Kielce, Poland, 25-736
    • 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, 70-215
    • 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
• Puerto Rico
  • Guaynabo, Puerto Rico, 00969
    • Teva Investigational Site 1243
• Romania
  • 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, 117997
    • Teva Investigational Site 5032
  • Moscow, Russian Federation, 125367
    • Teva Investigational Site 5041
  • 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
  • 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
    • Birmingham, 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 1252
    • Phoenix, Arizona, United States, 85018
      • Teva Investigational Site 1279
    • Tucson, Arizona, United States, 85741-3537
      • 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
    • Orlando, Florida, United States, 32806
      • Teva Investigational Site 1255
    • 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
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • Teva Investigational Site 1268
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Teva Investigational Site 1277
    • Shreveport, Louisiana, United States, 71103
      • Teva Investigational Site 1263
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Teva Investigational Site 1269
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Teva Investigational Site 1274
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Teva Investigational Site 1239
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Teva Investigational Site 1265
  • New York
    • Albany, New York, United States, 12205
      • Teva Investigational Site 1273
    • Amherst, New York, United States, 14226
      • Teva Investigational Site 1264
    • Cedarhurst, New York, United States, 11516
      • Teva Investigational Site 1283
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Teva Investigational Site 1249
    • Winston-Salem, North Carolina, United States, 27103
      • Teva Investigational Site 1262
  • Ohio
    • Akron, Ohio, United States, 44320
      • Teva Investigational Site 1261
    • Canton, Ohio, United States, 44718
      • Teva Investigational Site 1241
    • 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
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Teva Investigational Site 1258
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Teva Investigational Site 1281
  • Texas
    • San Antonio, Texas, United States, 78231
      • Teva Investigational Site 1284
  • Virginia
    • Richmond, Virginia, United States, 23298-0599
      • Teva Investigational Site 1248
    • Roanoke, Virginia, United States, 24018
      • Teva Investigational Site 1270
  • Washington
    • Tacoma, Washington, United States, 98405
      • Teva Investigational Site 1253

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846], with a relapsing-remitting disease course.
2. Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.5.
3. Subjects must be in a stable neurological condition between screening (month -1) and baseline visits (month 0).
4. Subjects must have had experienced one of the following:
5. At least one documented relapse in the 12 months prior to screening
6. At least two documented relapses in the 24 months prior to screening
7. One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
8. Subjects must be between 18 and 55 years of age, inclusive.
9. Subjects must have disease duration of at least 6 months (from first symptom) prior to screening.
10. Women of child-bearing potential must practice 2 acceptable methods of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)].
11. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria:

1. An onset of relapse or any treatment with corticosteroids (intravenous [iv], intramuscular [im] and/or per os [po]) or ACTH between month -1 (screening) and 0 (baseline).
2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
3. Use of immunosuppressive (including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
4. Previous use of either of the following: natalizumab (Tysabri®), cladribine or laquinimod.
5. Previous treatment with glatiramer acetate (Copaxone®) or IVIG within 3 months prior to screening visit.
6. Previous treatment with Interferon beta-1a (Avonex® or Rebif®) or Interferon beta-1b (Betaseron®).
7. Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
8. Previous total body irradiation or total lymphoid irradiation.
9. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
10. A known history of tuberculosis.
11. Acute infection 2 weeks prior to baseline visit.
12. Major trauma or surgery 2 weeks prior to baseline visit.
13. A history of vascular thrombosis (excluding catheter-site superficial venous thrombophlebitis).
14. A carrier state of factor V Leiden mutation (either homo- or heterozygous) by history or as disclosed at screening.
15. Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody as disclosed at screening visit.
16. Use of potent inhibitors of CYP3A4 within 2 weeks prior to baseline visit (see detailed list of drugs in protocol) (1 month for fluoxetine).
17. Use of amiodarone within 2 years prior to screening visit.
18. Pregnancy or breastfeeding.

19. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:

    • A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
    • A gastrointestinal disorder that may affect the absorption of study medication.
    • Renal, metabolic, endocrinological or hematological diseases.
    • Any form of chronic liver disease, including known non-alcoholic steatohepatitis.
    • A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin.
    • A QTc interval (obtained from either two ECG recordings at screening or from the mean value calculated from three measurements at baseline visit) which is ≥450msec.
    • A family history of Long-QT syndrome.
    • A history of drug and/or alcohol abuse.
    • Major psychiatric disorder.
    • A history of a convulsive disorder.
    • Known hypersensitivity to either of the following: mannitol, meglumine or sodium stearyl fumarate.
    • Known hypersensitivity that would preclude administration of laquinimod.
20. The subject's inability to give informed consent, or to complete the study, or if the subject is considered by the investigator to be, for any reason, an unsuitable candidate for this study.
21. A known history of sensitivity to Gadolinium.
22. Inability to successfully undergo MRI scanning.
23. A known history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation of Avonex®.
24. Subjects who suffer from any form of progressive MS
25. Any condition which the investigator feels may interfere with participation in the study
26. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
27. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
28. Previous treatment with immunomodulators within two months prior to screening
29. Pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive 1 capsule of placebo matching to laquinimod orally once daily for 24 months.	Drug: Placebo; Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Experimental: Laquinimod; Participants will receive 1 capsule of laquinimod 0.6 mg orally once daily for 24 months.	Drug: Laquinimod; Laquinimod will be administered per dose and schedule specified in the arm description.
Active Comparator: Avonex®; Participants will receive an injection of Avonex® 30 micrograms (mcg) given intramuscularly (IM) once weekly for 24 months.	Drug: Avonex®; Avonex® will be administered per dose and schedule specified in the arm description.; Other Names: Interferon β-1a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Rate of Confirmed Relapses	A relapse was defined as the appearance of new neurological abnormalities or the reappearance of previously observed neurological abnormalities; lasting at least 48 hours and immediately preceded by an improved neurological state of ≥30 days from onset of previous relapse, accompanied by observed objective neurological changes (an increase of ≥0.5 in Expanded Disability Status Scale [EDSS] score, or an increase of 1 grade in the score of 2 or more of the 7 Functional Systems [FS], or an increase of 2 grades in the score of 1 FS as compared to the previous evaluation). Total number of confirmed relapses during the treatment period was divided by the sum of number of days on study in the treatment period and then multiplied by the number of days in the year to calculate the annualized relapse rate. Annualized relapse rate was derived from a baseline-adjusted negative binomial regression.	Baseline up to Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score	The Multiple Sclerosis Functional Composite is an instrument assessing disability that consists of 3 clinical assessments. The 3 are Timed 25-Foot Walk, 9-Hole Peg Test which measures upper extremity (arm and hand) function, and PASAT (Paced Auditory Serial Addition Test) which is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. A Z-score is used to define a common metric from the 3 assessments that constitute the MSFC score. The study's population at baseline was used as reference population for the Z-score calculation. A Z-score of 0 represents the population mean at baseline. Higher Z-scores correspond to an improved outcome.	Baseline, Month 24
Percent Change From Baseline in Brain Volume	Change in brain volume was derived from MRI scans obtained at baseline and at Month 24.	Baseline, Month 24
Accumulation of Physical Disability Measured by the Number of Participants With Confirmed Progression of EDSS	A confirmed progression of EDSS was defined as a 1 point increase from baseline on EDSS score if baseline EDSS was between 0 and 5.0, or a 0.5 point increase if baseline EDSS was 5.5, confirmed 3 months later. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of confirmed progression (number of participants with confirmed progression of EDSS) sustained for 3 months. Progression could not be confirmed during a relapse.	Baseline up to Month 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in General Health Status as Assessed by the Short-Form General Health Survey (SF-36) Patient-Reported Questionnaire For Physical Component Summary (PCS) Scores	The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.	Baseline, Month 6, Month 12, Month 18, Month 24
Change From Baseline in General Health Status as Assessed by the Short-Form General Health Survey (SF-36) Patient-Reported Questionnaire For Mental Component Summary (MCS) Scores	The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.	Baseline, Month 6, Month 12, Month 18, Month 24
Cumulative Number of New or Enlarging Hypointense Lesions on Enhanced T1 Scans	The cumulative number of new or enlarging hypointense lesions was calculated as the sum of the numbers of new or enlarging hypointense lesions observed on scans taken at Months 12 and 24.	Months 12 and 24
Cumulative Number of Enhancing Lesions on T1-Weighted Images	The cumulative number of T1 Gadolinium (Gd)-enhancing lesions was calculated as the sum of the numbers of Gd-enhancing lesions observed on scans taken at Months 12 and 24.	Months 12 and 24

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

General Publications

• Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2008
• Primary Completion (Actual): June 10, 2011
• Study Completion (Actual): June 10, 2011

Study Registration Dates

• First Submitted: January 8, 2008
• First Submitted That Met QC Criteria: January 17, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: MS-LAQ-302; 2007-005450-23 (EudraCT Number)