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An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease

Sponsor
Teva Pharmaceutical Industries, Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00745615
Collaborator
(none)
257
Enrollment
45
Locations
6
Arms
139.5
Actual Duration (Months)
5.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multinational, multicenter, randomized, double-blind, parallel-group active extension of LAQ/5062 study (NCT00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in participants with relapsing remitting multiple sclerosis (RRMS), followed by an open-label phase of laquinimod 0.6 mg daily. This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063 OL (i.e., subsequent open-label extension). - The first period of the extension study is an active, double-blind period. Participants from the active treatment arms in LAQ/5062 continue their assigned treatment in blinded fashion. Participants who were assigned to placebo treatment in LAQ/5062 are equally randomized in blinded-fashion to laquinimod 0.6 mg or laquinimod 0.3 mg.

  • Once termination visit of LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor) is performed, all participants continue on laquinimod 0.6 mg daily as an open-label intervention. The open-label period continues as long as the Sponsor continues the development of laquinimod 0.6 mg for RRMS or early discontinuation.
Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
257 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Blinding performed by interactive voice response system (IVRS) and relevant only to the first period of the extension. General medical evaluations will be assessed separately from neurological assessment evaluations by two different neurologists/ physicians. Magnetic resonance imaging (MRI) scan evaluation will be performed at a central reading center by staff that does not have access to the clinical data.
Primary Purpose:
Treatment
Official Title:
An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL)
Actual Study Start Date :
Dec 7, 2005
Actual Primary Completion Date :
Jul 23, 2017
Actual Study Completion Date :
Jul 23, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Double-Blind: Laquinimod 0.3 mg

Participants who will be receiving laquinimod 0.3 milligram (mg) tablet once daily orally in double-blind core study, will continue to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.

Drug: Laquinimod
Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
Other Names:
  • TV-5600

    		•
    Experimental: Double-Blind: Laquinimod 0.6 mg

    Participants who will be receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, will continue to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.

    Drug: Laquinimod
    Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
    Other Names:
  • TV-5600

    		•
    Experimental: Double-Blind: Placebo/Laquinimod 0.3 mg

    Participants who will be receiving placebo matching to laquinimod 0.3 mg tablet once daily orally in double-blind core study, will receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.

    Drug: Laquinimod
    Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
    Other Names:
  • TV-5600

    • Drug: Placebo
    Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.
    Experimental: Double-Blind: Placebo/Laquinimod 0.6 mg

    Participants who will be receiving placebo matching to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, will receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.

    Drug: Laquinimod
    Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
    Other Names:
  • TV-5600

    • Drug: Placebo
    Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.
    Experimental: Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg

    Participants who will be receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, will receive laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor will continue the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).

    Drug: Laquinimod
    Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
    Other Names:
  • TV-5600

    		•
    Experimental: Open Label: Laquinimod 0.6 mg

    Participants who will be receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, will receive laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor will continue the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).

    Drug: Laquinimod
    Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.
    Other Names:
  • TV-5600

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Double-Blind Extension Period: Number of Participants With Adverse Events (AEs) [Baseline (Week 0) to Week 36]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

    2. Open-label Extension Period: Number of Participants With AEs [Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

    3. Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs [Baseline (Week 0) to Week 36]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.

    4. Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs [Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.

    Secondary Outcome Measures

    1. Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses [Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)]

      Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the Expanded disability status scale (EDSS); or one grade in the score of 2 or more of the 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).

    2. Double-Blind Period: Percentage of Relapse-Free Participants [Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)]

      Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the EDSS; or one grade in the score of 2 or more of the 7 FS (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS).

    3. Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images [At the end of active double-blind phase or termination/early termination visit (up to Week 36)]

      Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions. T1-weighted scan was taken after administration of gadolinium-gadopentetic acid (Gd-DTPA).

    4. Double-Blind Period: Number of New T2 Lesions [At the end of active double-blind phase or termination/early termination visit (up to Week 36)]

      Inflammatory disease activity was assessed by MRI measurement of the number of new T2 lesions.

    5. Double-Blind Period: Volume of T2 Lesions [At the end of active double-blind phase or termination/early termination visit (up to Week 36)]

      Volume of T2 lesion was assessed by magnetic MRI.

    6. Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans [At the end of active double-blind phase or termination/early termination visit (up to Week 36)]

      Inflammatory disease activity was assessed by MRI measurement of the number of new hypointense T1 lesions.

    7. Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score [At the end of active double-blind phase or termination/early termination visit (up to Week 36)]

      EDSS (developed by John F. Kurtzke) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and other functions). Each functional system score and an overall score ranges from 0 to 10, where 0 = Normal; 1-1.5 = No disability, but some abnormal neurological signs; 2-2.5 = Minimal disability; 3-4.5 = Moderate disability, affecting daily activities, but can still walk; 5-8 = More severe disability, impairing daily activities and requiring assistance with walking; 8.5-9.5 = Very severe disability, restricting to bed; 10 = Death due to MS. A lower score indicated less disability.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria - Participants must have completed the 36 weeks of treatment (completion of the full 36 weeks or as requested by the Sponsor) of the active double-blind phase. - Women of childbearing potential (for example, women who were not postmenopausal or surgically sterilized) must have practiced 2 acceptable methods of birth control for the duration of the study and until 30 days after the last dose of study medication (acceptable methods of birth control in this open-label extension phase included intrauterine devices, barrier methods [condom or diaphragm with spermicide], and hormonal methods of birth control [for example, oral contraceptive, contraceptive patch, and long-acting injectable contraceptive]). - Participants must have been willing and able to comply with the protocol requirements for the duration of LAQ/5063 OL. - Participants must have given signed, written informed consent prior to entering LAQ/5063 OL. - For the 36 months further extension: Participants must have completed the 24 months of treatment of the first period of the open label phase. Exclusion Criteria - For the 36 month further extension: Premature discontinuation from LAQ/5063 OL phase prior to completion of 24 months of treatment period. - Pregnancy or breastfeeding. - Participants with clinically significant or unstable medical or surgical condition, detected or worsened during the active double-blind phase of LAQ/5063, which would have precluded safe and complete study participation. - Use of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies within the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Previous treatment with immunomodulators with the exception of laquinimod (including interferon [IFN] 1a and 1b, glatiramer acetate, and intravenous [IV] immunoglobulin) within 2 months prior to entering the open-label phase for those subjects who had a time gap between termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of corticosteroids within 30 days prior to entering the open-label phase, except for IV methylprednisolone 1 grams/day for a maximum of 3 days, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of potent inhibitors of cytochrome P3A4 (CYP3A4) within 2 weeks prior to LAQ/5063 OL and/or use of fluoxetine 1 month prior to entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of the following substrates of cytochrome P1A2 (CYP1A2): theophylline and/or warfarin within 2 weeks prior to entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of amiodarone in the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Following the switch to new formulation (capsules), hypersensitivity to mannitol, meglumine, or sodium stearyl fumarate.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teva Investigational Site 382 Hradec Kralove 3 Czechia
    2 Teva Investigational Site 380 Praha 2 Czechia
    3 Teva Investigational Site 384 Praha 5- Motol Czechia
    4 Teva Investigational Site 681 Berlin Germany
    5 Teva Investigational Site 684 Erfurt Germany
    6 Teva Investigational Site 687 Hamburg Germany
    7 Teva Investigational Site 683 Mainz Germany
    8 Teva Investigational Site 686 Ulm Germany
    9 Teva Investigational Site 685 Wuerzburg Germany
    10 Teva Investigational Site 580 Debrecen Hungary
    11 Teva Investigational Site 581 Gyula Hungary
    12 Teva Investigational Site 583 Miskolc Hungary
    13 Teva Investigational Site 584 Veszprem Hungary
    14 Teva Investigational Site 981 Ramat -Gan IL Israel
    15 Teva Investigational Site 982 Haifa Israel
    16 Teva Investigational Site 980 Jerusalem Israel
    17 Teva Investigational Site 483 Cagliari Italy
    18 Teva Investigational Site 484 Milano Italy
    19 Teva Investigational Site 486 Milano Italy
    20 Teva Investigational Site 488 Siena Italy
    21 Teva Investigational Site 281 Bydgoszcz Poland
    22 Teva Investigational Site 280 Katowice Poland
    23 Teva Investigational Site 285 Katowice Poland
    24 Teva Investigational Site 283 Lodz Poland
    25 Teva Investigational Site 284 Lublin Poland
    26 Teva Investigational Site 282 Wroclaw Poland
    27 Teva Investigational Site 186 Moscow Russian Federation
    28 Teva Investigational Site 187 Moscow Russian Federation
    29 Teva Investigational Site 188 Moscow Russian Federation
    30 Teva Investigational Site 189 Moscow Russian Federation
    31 Teva Investigational Site 180 Saint Petersburg Russian Federation
    32 Teva Investigational Site 181 St. Petersburg Russian Federation
    33 Teva Investigational Site 182 St. Petersburg Russian Federation
    34 Teva Investigational Site 184 St. Petersburg Russian Federation
    35 Teva Investigational Site 185 St. Petersburg Russian Federation
    36 Teva Investigational Site 782 Barakaldo Spain
    37 Teva Investigational Site 785 Barcelona Spain
    38 Teva Investigational Site 781 Bilbao Spain
    39 Teva Investigational Site 784 L'Hospitalet de Llobregat Spain
    40 Teva Investigational Site 780 Madrid Spain
    41 Teva Investigational Site 783 Sevilla Spain
    42 Teva Investigational Site 884 Liverpool United Kingdom
    43 Teva Investigational Site 882 London United Kingdom
    44 Teva Investigational Site 881 Sheffield United Kingdom
    45 Teva Investigational Site 883 Stoke on Trent United Kingdom

    Sponsors and Collaborators

    • Teva Pharmaceutical Industries, Ltd.

    Investigators

    • Principal Investigator: Giancarlo Comi, Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Pharmaceutical Industries, Ltd.
    ClinicalTrials.gov Identifier:
    NCT00745615
    Other Study ID Numbers:
    • LAQ/5063OL
    • LAQ/5063
    • 2005-004334-41
    First Posted:
    Sep 3, 2008
    Last Update Posted:
    Mar 27, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis

    Study Results

    Participant Flow

    Recruitment Details This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063OL (i.e., subsequent open-label extension). Participants who completed double-blind core study LAQ/5062 (NCT00349193) and agreed to continue in active extension study were enrolled in this study.
    Pre-assignment Detail Double-blind extension: Participants treated with placebo in LAQ/5062 study were equally randomized to one of 2 groups: Laquinimod 0.6 mg or Laquinimod 0.3 mg. Participants previously treated with laquinimod 0.6 mg or laquinimod 0.3 mg continued on their original treatment. Open-label extension: All participants received laquinimod 0.6 mg.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg Open Label: Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 milligram (mg) tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for relapsing-remitting multiple sclerosis [RRMS]) or early discontinuation (up to approximately 10.5 years). Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
    Period Title: Double-Blind Extension (36 Weeks)
    STARTED 80 94 39 44 0 0
    COMPLETED 75 87 38 39 0 0
    NOT COMPLETED 5 7 1 5 0 0
    Period Title: Double-Blind Extension (36 Weeks)
    STARTED 0 0 0 0 96 113
    COMPLETED 0 0 0 0 5 5
    NOT COMPLETED 0 0 0 0 91 108

    Baseline Characteristics

    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg Total
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Total of all reporting groups
    Overall Participants 80 94 39 44 257
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    34.4
    (8.3)
    33.4
    (8.7)
    34.5
    (8.8)
    31.0
    (6.6)
    33.5
    (8.3)
    Sex: Female, Male (Count of Participants)
    Female
    51
    63.8%
    53
    56.4%
    23
    59%
    27
    61.4%
    154
    59.9%
    Male
    29
    36.3%
    41
    43.6%
    16
    41%
    17
    38.6%
    103
    40.1%
    Race/Ethnicity, Customized (Count of Participants)
    Asian/Oriental
    1
    1.3%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    Black of African Heritage
    0
    0%
    1
    1.1%
    0
    0%
    0
    0%
    1
    0.4%
    Caucasian
    79
    98.8%
    93
    98.9%
    39
    100%
    44
    100%
    255
    99.2%
    Region of Enrollment (Count of Participants)
    Czech Republic
    8
    10%
    7
    7.4%
    3
    7.7%
    3
    6.8%
    21
    8.2%
    Germany
    7
    8.8%
    7
    7.4%
    5
    12.8%
    3
    6.8%
    22
    8.6%
    Hungary
    7
    8.8%
    7
    7.4%
    3
    7.7%
    3
    6.8%
    20
    7.8%
    Israel
    3
    3.8%
    3
    3.2%
    3
    7.7%
    2
    4.5%
    11
    4.3%
    Italy
    8
    10%
    9
    9.6%
    2
    5.1%
    4
    9.1%
    23
    8.9%
    Poland
    19
    23.8%
    21
    22.3%
    11
    28.2%
    9
    20.5%
    60
    23.3%
    Russia
    18
    22.5%
    28
    29.8%
    9
    23.1%
    14
    31.8%
    69
    26.8%
    Spain
    7
    8.8%
    8
    8.5%
    3
    7.7%
    5
    11.4%
    23
    8.9%
    United Kingdom
    3
    3.8%
    4
    4.3%
    0
    0%
    1
    2.3%
    8
    3.1%

    Outcome Measures

    1. Primary Outcome
    Title Double-Blind Extension Period: Number of Participants With Adverse Events (AEs)
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
    Time Frame Baseline (Week 0) to Week 36

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 80 94 39 44
    Count of Participants [Participants]
    57
    71.3%
    66
    70.2%
    23
    59%
    32
    72.7%
    2. Primary Outcome
    Title Open-label Extension Period: Number of Participants With AEs
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
    Time Frame Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL.
    Arm/Group Title Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg Open Label: Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years). Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
    Measure Participants 96 113
    Count of Participants [Participants]
    86
    107.5%
    100
    106.4%
    3. Primary Outcome
    Title Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
    Time Frame Baseline (Week 0) to Week 36

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 80 94 39 44
    Due to any reason
    5
    6.3%
    7
    7.4%
    1
    2.6%
    5
    11.4%
    Due to AEs
    2
    2.5%
    3
    3.2%
    1
    2.6%
    1
    2.3%
    4. Primary Outcome
    Title Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
    Time Frame Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL.
    Arm/Group Title Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg Open Label: Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years). Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
    Measure Participants 96 113
    Due to any reason
    91
    113.8%
    108
    114.9%
    Due to AEs
    1
    1.3%
    9
    9.6%
    5. Secondary Outcome
    Title Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses
    Description Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the Expanded disability status scale (EDSS); or one grade in the score of 2 or more of the 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).
    Time Frame Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 80 94 39 44
    Mean (Standard Deviation) [relapses]
    0.39
    (0.68)
    0.36
    (0.58)
    0.38
    (0.54)
    0.39
    (0.72)
    6. Secondary Outcome
    Title Double-Blind Period: Percentage of Relapse-Free Participants
    Description Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the EDSS; or one grade in the score of 2 or more of the 7 FS (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS).
    Time Frame Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 80 94 39 44
    Number [percentage of participants]
    70.0
    87.5%
    68.1
    72.4%
    64.1
    164.4%
    72.7
    165.2%
    7. Secondary Outcome
    Title Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images
    Description Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions. T1-weighted scan was taken after administration of gadolinium-gadopentetic acid (Gd-DTPA).
    Time Frame At the end of active double-blind phase or termination/early termination visit (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 66 82 36 38
    Mean (Standard Deviation) [lesions]
    2.50
    (4.77)
    2.18
    (5.67)
    2.64
    (4.32)
    1.63
    (3.04)
    8. Secondary Outcome
    Title Double-Blind Period: Number of New T2 Lesions
    Description Inflammatory disease activity was assessed by MRI measurement of the number of new T2 lesions.
    Time Frame At the end of active double-blind phase or termination/early termination visit (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 66 82 36 38
    Mean (Standard Deviation) [lesions]
    4.58
    (8.36)
    3.55
    (6.76)
    4.47
    (6.23)
    2.42
    (3.45)
    9. Secondary Outcome
    Title Double-Blind Period: Volume of T2 Lesions
    Description Volume of T2 lesion was assessed by magnetic MRI.
    Time Frame At the end of active double-blind phase or termination/early termination visit (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 66 82 36 38
    Mean (Standard Deviation) [cubic millimeters (mm^3)]
    16930
    (12816)
    17015
    (15298)
    17436
    (16808)
    15816
    (14274)
    10. Secondary Outcome
    Title Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans
    Description Inflammatory disease activity was assessed by MRI measurement of the number of new hypointense T1 lesions.
    Time Frame At the end of active double-blind phase or termination/early termination visit (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 66 82 36 38
    Mean (Standard Deviation) [lesions]
    1.23
    (2.69)
    0.70
    (2.01)
    1.11
    (2.11)
    1.24
    (2.67)
    11. Secondary Outcome
    Title Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score
    Description EDSS (developed by John F. Kurtzke) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and other functions). Each functional system score and an overall score ranges from 0 to 10, where 0 = Normal; 1-1.5 = No disability, but some abnormal neurological signs; 2-2.5 = Minimal disability; 3-4.5 = Moderate disability, affecting daily activities, but can still walk; 5-8 = More severe disability, impairing daily activities and requiring assistance with walking; 8.5-9.5 = Very severe disability, restricting to bed; 10 = Death due to MS. A lower score indicated less disability.
    Time Frame At the end of active double-blind phase or termination/early termination visit (up to Week 36)

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg Double-Blind: Placebo/Laquinimod 0.3 mg Double-Blind: Placebo/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
    Measure Participants 78 92 39 43
    Mean (Standard Deviation) [units on a scale]
    2.53
    (1.60)
    2.44
    (1.21)
    2.51
    (1.40)
    2.27
    (1.35)

    Adverse Events

    Time Frame Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
    Adverse Event Reporting Description AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
    Arm/Group Title Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg Open Label: Laquinimod 0.6 mg Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
    Arm/Group Description Participants who were receiving either laquinimod 0.3 mg or placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) or placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36. Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years). Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
    All Cause Mortality
    Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg Open Label: Laquinimod 0.6 mg Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/119 (0%) 0/138 (0%) 2/113 (1.8%) 0/96 (0%)
    Serious Adverse Events
    Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg Open Label: Laquinimod 0.6 mg Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/119 (5%) 6/138 (4.3%) 30/113 (26.5%) 19/96 (19.8%)
    Blood and lymphatic system disorders
    Leukocytosis 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Thrombocytopenia 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Haemorrhagic anaemia 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Lymphadenopathy 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    Cardiac disorders
    Acute myocardial infarction 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Arrhythmia supraventricular 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Atrial fibrillation 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Cardiomyopathy 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Myocardial fibrosis 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Supraventricular tachycardia 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Tricuspid valve incompetence 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 2
    Ear and labyrinth disorders
    Vertigo 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Vertigo positional 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Vestibular disorder 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Eye disorders
    Retinal degeneration 0/119 (0%) 0 1/138 (0.7%) 1 0/113 (0%) 0 0/96 (0%) 0
    Gastrointestinal disorders
    Colitis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Crohn's disease 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Duodenal ulcer 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Gastric ulcer 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Umbilical hernia 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Upper gastrointestinal haemorrhage 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    General disorders
    Gait disturbance 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Oedema peripheral 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Systemic inflammatory response syndrome 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Hepatobiliary disorders
    Cholecystitis acute 0/119 (0%) 0 0/138 (0%) 0 2/113 (1.8%) 2 1/96 (1%) 1
    Cholelithiasis 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Immune system disorders
    Drug hypersensitivity 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Infections and infestations
    Anal abscess 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Borrelia infection 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Chronic tonsillitis 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 2/96 (2.1%) 2
    Clostridium difficile colitis 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Cytomegalovirus infection 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Endometritis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Gastroenteritis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Peritonitis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Pneumonia bacterial 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Pyelonephritis 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Salpingo-oophoritis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 2 0/96 (0%) 0
    Subcutaneous abscess 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Urinary tract infection 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 1/96 (1%) 1
    Sepsis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Subacute endocarditis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Fall 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Fibula fracture 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Humerus fracture 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Joint dislocation 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Radius fracture 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Scrotal haematoma 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Spinal compression fracture 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Subdural haematoma 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Tibia fracture 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Wrist fracture 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Investigations
    Borrelia test positive 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    C-reactive protein increased 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Cardiovascular evaluation 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    HIV test positive 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Weight decreased 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Metabolism and nutrition disorders
    Malnutrition 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/119 (0%) 0 0/138 (0%) 0 2/113 (1.8%) 2 1/96 (1%) 1
    Back disorder 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    Back pain 1/119 (0.8%) 1 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Groin pain 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Pituitary tumour benign 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    Uterine leiomyoma 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    Adenocarcinoma gastric 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    Metastatic neoplasm 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Nervous system disorders
    Aphasia 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Carpal tunnel syndrome 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Cerebellar ischaemia 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Demyelination 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Generalised tonic-clonic seizure 0/119 (0%) 0 1/138 (0.7%) 1 0/113 (0%) 0 0/96 (0%) 0
    Hemiparesis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Optic neuritis 0/119 (0%) 0 1/138 (0.7%) 1 0/113 (0%) 0 0/96 (0%) 0
    Vertebrobasilar insufficiency 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Ataxia 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Renal and urinary disorders
    Calculus urinary 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Urinary incontinence 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Reproductive system and breast disorders
    Cervical dysplasia 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Endometriosis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Ovarian cyst 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Respiratory, thoracic and mediastinal disorders
    Paranasal cyst 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Atelectasis 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    Pleural effusion 1/119 (0.8%) 1 0/138 (0%) 0 0/113 (0%) 0 0/96 (0%) 0
    Surgical and medical procedures
    Cervical conisation 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 0/96 (0%) 0
    Knee operation 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Meniscus operation 0/119 (0%) 0 1/138 (0.7%) 1 0/113 (0%) 0 0/96 (0%) 0
    Tonsillectomy 0/119 (0%) 0 1/138 (0.7%) 1 0/113 (0%) 0 0/96 (0%) 0
    Tricuspid valve repair 0/119 (0%) 0 0/138 (0%) 0 0/113 (0%) 0 1/96 (1%) 1
    Uterine dilation and curettage 1/119 (0.8%) 1 1/138 (0.7%) 1 0/113 (0%) 0 0/96 (0%) 0
    Other (Not Including Serious) Adverse Events
    Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg Open Label: Laquinimod 0.6 mg Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 68/119 (57.1%) 74/138 (53.6%) 95/113 (84.1%) 82/96 (85.4%)
    Blood and lymphatic system disorders
    Anaemia 0/119 (0%) 0 1/138 (0.7%) 1 7/113 (6.2%) 8 8/96 (8.3%) 13
    Cardiac disorders
    Tachycardia 3/119 (2.5%) 3 6/138 (4.3%) 6 4/113 (3.5%) 6 5/96 (5.2%) 5
    Gastrointestinal disorders
    Abdominal pain 0/119 (0%) 0 1/138 (0.7%) 1 11/113 (9.7%) 13 1/96 (1%) 1
    Abdominal pain upper 0/119 (0%) 0 5/138 (3.6%) 6 7/113 (6.2%) 9 2/96 (2.1%) 2
    Diarrhoea 2/119 (1.7%) 3 2/138 (1.4%) 3 6/113 (5.3%) 6 4/96 (4.2%) 7
    Dyspepsia 2/119 (1.7%) 4 3/138 (2.2%) 5 4/113 (3.5%) 5 8/96 (8.3%) 10
    Nausea 2/119 (1.7%) 5 2/138 (1.4%) 2 2/113 (1.8%) 2 5/96 (5.2%) 6
    Toothache 2/119 (1.7%) 2 2/138 (1.4%) 2 6/113 (5.3%) 6 2/96 (2.1%) 2
    Vomiting 2/119 (1.7%) 3 2/138 (1.4%) 3 3/113 (2.7%) 4 5/96 (5.2%) 5
    Gastrooesophageal reflux disease 0/119 (0%) 0 0/138 (0%) 0 2/113 (1.8%) 2 5/96 (5.2%) 5
    General disorders
    Asthenia 1/119 (0.8%) 1 2/138 (1.4%) 2 5/113 (4.4%) 8 6/96 (6.3%) 8
    Fatigue 3/119 (2.5%) 3 4/138 (2.9%) 5 12/113 (10.6%) 15 2/96 (2.1%) 2
    Pyrexia 1/119 (0.8%) 6 4/138 (2.9%) 4 6/113 (5.3%) 15 5/96 (5.2%) 5
    Immune system disorders
    Seasonal allergy 1/119 (0.8%) 1 0/138 (0%) 0 1/113 (0.9%) 1 5/96 (5.2%) 6
    Infections and infestations
    Bronchitis 3/119 (2.5%) 3 2/138 (1.4%) 2 10/113 (8.8%) 13 11/96 (11.5%) 14
    Cystitis 1/119 (0.8%) 1 0/138 (0%) 0 8/113 (7.1%) 21 6/96 (6.3%) 6
    Gastroenteritis 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 5/96 (5.2%) 6
    Influenza 0/119 (0%) 0 0/138 (0%) 0 8/113 (7.1%) 9 8/96 (8.3%) 9
    Nasopharyngitis 18/119 (15.1%) 25 23/138 (16.7%) 30 38/113 (33.6%) 96 39/96 (40.6%) 80
    Oral herpes 3/119 (2.5%) 3 2/138 (1.4%) 2 7/113 (6.2%) 15 7/96 (7.3%) 9
    Pharyngitis 5/119 (4.2%) 8 3/138 (2.2%) 3 12/113 (10.6%) 18 10/96 (10.4%) 21
    Respiratory tract infection viral 1/119 (0.8%) 1 1/138 (0.7%) 1 10/113 (8.8%) 15 10/96 (10.4%) 15
    Rhinitis 2/119 (1.7%) 2 4/138 (2.9%) 4 7/113 (6.2%) 8 11/96 (11.5%) 14
    Tonsillitis 1/119 (0.8%) 1 1/138 (0.7%) 1 6/113 (5.3%) 6 8/96 (8.3%) 15
    Upper respiratory tract infection 5/119 (4.2%) 6 3/138 (2.2%) 3 12/113 (10.6%) 22 14/96 (14.6%) 33
    Urinary tract infection 6/119 (5%) 8 3/138 (2.2%) 6 9/113 (8%) 11 8/96 (8.3%) 15
    Viral infection 0/119 (0%) 0 1/138 (0.7%) 1 2/113 (1.8%) 3 5/96 (5.2%) 6
    Furuncle 0/119 (0%) 0 0/138 (0%) 0 6/113 (5.3%) 9 2/96 (2.1%) 2
    Sinusitis 0/119 (0%) 0 2/138 (1.4%) 2 7/113 (6.2%) 9 4/96 (4.2%) 5
    Injury, poisoning and procedural complications
    Contusion 0/119 (0%) 0 2/138 (1.4%) 2 9/113 (8%) 9 5/96 (5.2%) 6
    Fall 0/119 (0%) 0 2/138 (1.4%) 2 6/113 (5.3%) 8 1/96 (1%) 1
    Investigations
    Blood cholesterol increased 0/119 (0%) 0 0/138 (0%) 0 6/113 (5.3%) 8 1/96 (1%) 1
    Blood fibrinogen increased 3/119 (2.5%) 3 6/138 (4.3%) 7 7/113 (6.2%) 7 5/96 (5.2%) 5
    C-reactive protein increased 3/119 (2.5%) 3 2/138 (1.4%) 2 8/113 (7.1%) 10 5/96 (5.2%) 6
    Haematocrit decreased 2/119 (1.7%) 2 0/138 (0%) 0 3/113 (2.7%) 3 5/96 (5.2%) 7
    Neutrophil count increased 3/119 (2.5%) 3 1/138 (0.7%) 1 6/113 (5.3%) 6 2/96 (2.1%) 2
    White blood cell count increased 3/119 (2.5%) 3 3/138 (2.2%) 3 6/113 (5.3%) 6 3/96 (3.1%) 3
    Metabolism and nutrition disorders
    Hypercholesterolaemia 0/119 (0%) 0 2/138 (1.4%) 2 5/113 (4.4%) 5 6/96 (6.3%) 6
    Musculoskeletal and connective tissue disorders
    Arthralgia 5/119 (4.2%) 6 3/138 (2.2%) 3 17/113 (15%) 22 10/96 (10.4%) 18
    Back pain 4/119 (3.4%) 5 12/138 (8.7%) 15 31/113 (27.4%) 54 22/96 (22.9%) 32
    Intervertebral disc protrusion 0/119 (0%) 0 0/138 (0%) 0 7/113 (6.2%) 7 2/96 (2.1%) 2
    Musculoskeletal pain 1/119 (0.8%) 1 0/138 (0%) 0 7/113 (6.2%) 9 2/96 (2.1%) 3
    Neck pain 4/119 (3.4%) 6 2/138 (1.4%) 2 4/113 (3.5%) 4 5/96 (5.2%) 5
    Pain in extremity 1/119 (0.8%) 1 2/138 (1.4%) 2 3/113 (2.7%) 3 6/96 (6.3%) 6
    Spinal osteoarthritis 1/119 (0.8%) 1 0/138 (0%) 0 6/113 (5.3%) 6 1/96 (1%) 1
    Nervous system disorders
    Dizziness 6/119 (5%) 6 5/138 (3.6%) 6 1/113 (0.9%) 1 4/96 (4.2%) 4
    Headache 16/119 (13.4%) 19 16/138 (11.6%) 20 17/113 (15%) 23 21/96 (21.9%) 29
    Multiple sclerosis relapse 1/119 (0.8%) 1 0/138 (0%) 0 1/113 (0.9%) 1 5/96 (5.2%) 7
    Psychiatric disorders
    Depression 2/119 (1.7%) 2 1/138 (0.7%) 2 11/113 (9.7%) 16 9/96 (9.4%) 10
    Sleep disorder 0/119 (0%) 0 0/138 (0%) 0 1/113 (0.9%) 1 5/96 (5.2%) 7
    Insomnia 1/119 (0.8%) 1 0/138 (0%) 0 5/113 (4.4%) 5 5/96 (5.2%) 5
    Reproductive system and breast disorders
    Erectile dysfunction 0/119 (0%) 0 0/138 (0%) 0 3/113 (2.7%) 4 5/96 (5.2%) 5
    Respiratory, thoracic and mediastinal disorders
    Catarrh 1/119 (0.8%) 1 2/138 (1.4%) 2 5/113 (4.4%) 6 5/96 (5.2%) 5
    Cough 2/119 (1.7%) 2 6/138 (4.3%) 7 4/113 (3.5%) 6 5/96 (5.2%) 5
    Vascular disorders
    Hypertension 1/119 (0.8%) 1 1/138 (0.7%) 1 5/113 (4.4%) 5 7/96 (7.3%) 9

    Limitations/Caveats

    Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.

    Results Point of Contact

    Name/Title Director, Clinical Research
    Organization Teva Branded Pharmaceutical Products, R&D Inc
    Phone 215-591-3000
    Email ustevatrials@tevapharm.com
    Responsible Party:
    Teva Pharmaceutical Industries, Ltd.
    ClinicalTrials.gov Identifier:
    NCT00745615
    Other Study ID Numbers:
    • LAQ/5063OL
    • LAQ/5063
    • 2005-004334-41
    First Posted:
    Sep 3, 2008
    Last Update Posted:
    Mar 27, 2019
    Last Verified:
    Mar 1, 2019