Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LAQ/5063 | Other Identifier | Sponsor ID | |
| 2005-004334-41 | EudraCT Number |
Not provided
Not provided
Not provided
Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind: Laquinimod 0.3 mg | Experimental | 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. |
|
| Double-Blind: Laquinimod 0.6 mg | Experimental | 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. |
|
| Double-Blind: Placebo/Laquinimod 0.3 mg | Experimental | 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. |
|
| Double-Blind: Placebo/Laquinimod 0.6 mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laquinimod | Drug | Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Double-Blind Extension Period: Number of Participants With Adverse Events (AEs) | 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'. | Baseline (Week 0) to Week 36 |
| Open-label Extension Period: Number of Participants With AEs | 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'. | 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) |
| Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs | 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. | Baseline (Week 0) to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses | 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]). |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Comi | Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 382 | Hradec Králové | Czechia | ||||
| Teva Investigational Site 380 |
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind: Laquinimod 0.3 mg | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Extension (36 Weeks) |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2016 |
Not provided
Not provided
Not provided
Not provided
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.
| Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg | Experimental | 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). |
|
| Open Label: Laquinimod 0.6 mg | Experimental | 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). |
|
|
| Placebo | Drug | Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms. |
|
| Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs | 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. | 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) |
| Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36) |
| Double-Blind Period: Percentage of Relapse-Free Participants | 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). | Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36) |
| Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images | 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). | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| Double-Blind Period: Number of New T2 Lesions | Inflammatory disease activity was assessed by MRI measurement of the number of new T2 lesions. | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| Double-Blind Period: Volume of T2 Lesions | Volume of T2 lesion was assessed by magnetic MRI. | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans | Inflammatory disease activity was assessed by MRI measurement of the number of new hypointense T1 lesions. | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score | 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. | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| Prague |
| Czechia |
| Teva Investigational Site 384 | Praha 5- Motol | Czechia |
| Teva Investigational Site 681 | Berlin | Germany |
| Teva Investigational Site 684 | Erfurt | Germany |
| Teva Investigational Site 687 | Hamburg | Germany |
| Teva Investigational Site 683 | Mainz | Germany |
| Teva Investigational Site 686 | Ulm | Germany |
| Teva Investigational Site 685 | Würzburg | Germany |
| Teva Investigational Site 580 | Debrecen | Hungary |
| Teva Investigational Site 581 | Gyula | Hungary |
| Teva Investigational Site 583 | Miskolc | Hungary |
| Teva Investigational Site 584 | Veszprém | Hungary |
| Teva Investigational Site 981 | Ramat Gan | IL | Israel |
| Teva Investigational Site 982 | Haifa | Israel |
| Teva Investigational Site 980 | Jerusalem | Israel |
| Teva Investigational Site 483 | Cagliari | Italy |
| Teva Investigational Site 484 | Milan | Italy |
| Teva Investigational Site 486 | Milan | Italy |
| Teva Investigational Site 488 | Siena | Italy |
| Teva Investigational Site 281 | Bydgoszcz | Poland |
| Teva Investigational Site 280 | Katowice | Poland |
| Teva Investigational Site 285 | Katowice | Poland |
| Teva Investigational Site 283 | Lodz | Poland |
| Teva Investigational Site 284 | Lublin | Poland |
| Teva Investigational Site 282 | Wroclaw | Poland |
| Teva Investigational Site 186 | Moscow | Russia |
| Teva Investigational Site 187 | Moscow | Russia |
| Teva Investigational Site 188 | Moscow | Russia |
| Teva Investigational Site 189 | Moscow | Russia |
| Teva Investigational Site 180 | Saint Petersburg | Russia |
| Teva Investigational Site 181 | Saint Petersburg | Russia |
| Teva Investigational Site 182 | Saint Petersburg | Russia |
| Teva Investigational Site 184 | Saint Petersburg | Russia |
| Teva Investigational Site 185 | Saint Petersburg | Russia |
| Teva Investigational Site 782 | Barakaldo | Spain |
| Teva Investigational Site 785 | Barcelona | Spain |
| Teva Investigational Site 781 | Bilbao | Spain |
| Teva Investigational Site 784 | L'Hospitalet de Llobregat | Spain |
| Teva Investigational Site 780 | Madrid | Spain |
| Teva Investigational Site 783 | Seville | Spain |
| Teva Investigational Site 884 | Liverpool | United Kingdom |
| Teva Investigational Site 882 | London | United Kingdom |
| Teva Investigational Site 881 | Sheffield | United Kingdom |
| Teva Investigational Site 883 | Stoke-on-Trent | United Kingdom |
| Double-Blind: Laquinimod 0.6 mg |
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. |
| FG002 | Double-Blind: Placebo/Laquinimod 0.3 mg | 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. |
| FG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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. |
| FG004 | Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg | 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). |
| FG005 | Open Label: Laquinimod 0.6 mg | 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label (up to Approx 10.5 Years) |
|
|
Intent-to-treat (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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind: Laquinimod 0.3 mg | 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. |
| BG001 | Double-Blind: Laquinimod 0.6 mg | 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. |
| BG002 | Double-Blind: Placebo/Laquinimod 0.3 mg | 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. |
| BG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Double-Blind Extension Period: Number of Participants With Adverse Events (AEs) | 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'. | 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. | Posted | Count of Participants | Participants | Baseline (Week 0) to Week 36 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Open-label Extension Period: Number of Participants With AEs | 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'. | Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs | 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. | 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. | Posted | Count of Participants | Participants | Baseline (Week 0) to Week 36 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs | 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. | Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses | 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]). | 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. | Posted | Mean | Standard Deviation | relapses | Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Percentage of Relapse-Free Participants | 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). | 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. | Posted | Number | percentage of participants | Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images | 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). | 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. | Posted | Mean | Standard Deviation | lesions | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Number of New T2 Lesions | Inflammatory disease activity was assessed by MRI measurement of the number of new T2 lesions. | 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. | Posted | Mean | Standard Deviation | lesions | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Volume of T2 Lesions | Volume of T2 lesion was assessed by magnetic MRI. | 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. | Posted | Mean | Standard Deviation | cubic millimeters (mm^3) | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans | Inflammatory disease activity was assessed by MRI measurement of the number of new hypointense T1 lesions. | 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. | Posted | Mean | Standard Deviation | lesions | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | At the end of active double-blind phase or termination/early termination visit (up to Week 36) |
|
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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg | 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. | 0 | 119 | 6 | 119 | 68 | 119 |
| EG001 | Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg | 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. | 0 | 138 | 6 | 138 | 74 | 138 |
| EG002 | Open Label: Laquinimod 0.6 mg | 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). | 2 | 113 | 30 | 113 | 95 | 113 |
| EG003 | Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg | 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). | 0 | 96 | 19 | 96 | 82 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial fibrosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Scrotal haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Borrelia test positive | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiovascular evaluation | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| HIV test positive | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back disorder | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebellar ischaemia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cervical conisation | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Meniscus operation | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Tonsillectomy | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Tricuspid valve repair | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Uterine dilation and curettage | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Subacute endocarditis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
|
Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc | 215-591-3000 | ustevatrials@tevapharm.com |
| Mar 4, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C476223 | laquinimod |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Physician Decision |
|
| Adverse Event |
|
| Pregnancy |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Death |
|
| Other Than Specified |
|
| Male |
|
| Black of African Heritage |
|
| Caucasian |
|
| Germany |
|
| Hungary |
|
| Israel |
|
| Italy |
|
| Poland |
|
| Russia |
|
| Spain |
|
| United Kingdom |
|
| Open Label: Laquinimod 0.6 mg |
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). |
|
|
| OG002 | Double-Blind: Placebo/Laquinimod 0.3 mg | 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. |
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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 0.6 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). |
|
|
| OG001 | Double-Blind: Laquinimod 0.6 mg | 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. |
| OG002 | Double-Blind: Placebo/Laquinimod 0.3 mg | 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. |
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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. |
|
|
| OG001 |
| Double-Blind: Laquinimod 0.6 mg |
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. |
| OG002 | Double-Blind: Placebo/Laquinimod 0.3 mg | 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. |
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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. |
|
|
| OG002 |
| Double-Blind: Placebo/Laquinimod 0.3 mg |
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. |
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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 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. |
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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 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.
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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 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. |
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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 0.6 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. |
| OG002 | Double-Blind: Placebo/Laquinimod 0.3 mg | 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. |
| OG003 | Double-Blind: Placebo/Laquinimod 0.6 mg | 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. |
|
|