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

NCT ID: NCT00745615

Last Updated: 2019-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-07

Study Completion Date

2017-07-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Laquinimod

Intervention Type DRUG

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

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.

Group Type EXPERIMENTAL

Laquinimod

Intervention Type DRUG

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

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.

Group Type EXPERIMENTAL

Laquinimod

Intervention Type DRUG

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

Placebo

Intervention Type DRUG

Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.

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.

Group Type EXPERIMENTAL

Laquinimod

Intervention Type DRUG

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

Placebo

Intervention Type DRUG

Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.

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).

Group Type EXPERIMENTAL

Laquinimod

Intervention Type DRUG

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

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).

Group Type EXPERIMENTAL

Laquinimod

Intervention Type DRUG

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

Interventions

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Laquinimod

Laquinimod tablets/capsules will be administered as per the dose and schedule specified in the respective arms.

Intervention Type DRUG

Placebo

Placebo matching to laquinimod will be administered as per the dose and schedule specified in the respective arms.

Intervention Type DRUG

Other Intervention Names

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TV-5600

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharmaceutical Industries, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giancarlo Comi

Role: PRINCIPAL_INVESTIGATOR

Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy

Locations

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Teva Investigational Site 382

Hradec Králové, , Czechia

Site Status

Teva Investigational Site 380

Prague, , Czechia

Site Status

Teva Investigational Site 384

Praha 5- Motol, , Czechia

Site Status

Teva Investigational Site 681

Berlin, , Germany

Site Status

Teva Investigational Site 684

Erfurt, , Germany

Site Status

Teva Investigational Site 687

Hamburg, , Germany

Site Status

Teva Investigational Site 683

Mainz, , Germany

Site Status

Teva Investigational Site 686

Ulm, , Germany

Site Status

Teva Investigational Site 685

Würzburg, , Germany

Site Status

Teva Investigational Site 580

Debrecen, , Hungary

Site Status

Teva Investigational Site 581

Gyula, , Hungary

Site Status

Teva Investigational Site 583

Miskolc, , Hungary

Site Status

Teva Investigational Site 584

Veszprém, , Hungary

Site Status

Teva Investigational Site 981

Ramat Gan, IL, Israel

Site Status

Teva Investigational Site 982

Haifa, , Israel

Site Status

Teva Investigational Site 980

Jerusalem, , Israel

Site Status

Teva Investigational Site 483

Cagliari, , Italy

Site Status

Teva Investigational Site 484

Milan, , Italy

Site Status

Teva Investigational Site 486

Milan, , Italy

Site Status

Teva Investigational Site 488

Siena, , Italy

Site Status

Teva Investigational Site 281

Bydgoszcz, , Poland

Site Status

Teva Investigational Site 280

Katowice, , Poland

Site Status

Teva Investigational Site 285

Katowice, , Poland

Site Status

Teva Investigational Site 283

Lodz, , Poland

Site Status

Teva Investigational Site 284

Lublin, , Poland

Site Status

Teva Investigational Site 282

Wroclaw, , Poland

Site Status

Teva Investigational Site 186

Moscow, , Russia

Site Status

Teva Investigational Site 187

Moscow, , Russia

Site Status

Teva Investigational Site 188

Moscow, , Russia

Site Status

Teva Investigational Site 189

Moscow, , Russia

Site Status

Teva Investigational Site 180

Saint Petersburg, , Russia

Site Status

Teva Investigational Site 181

Saint Petersburg, , Russia

Site Status

Teva Investigational Site 182

Saint Petersburg, , Russia

Site Status

Teva Investigational Site 184

Saint Petersburg, , Russia

Site Status

Teva Investigational Site 185

Saint Petersburg, , Russia

Site Status

Teva Investigational Site 782

Barakaldo, , Spain

Site Status

Teva Investigational Site 785

Barcelona, , Spain

Site Status

Teva Investigational Site 781

Bilbao, , Spain

Site Status

Teva Investigational Site 784

L'Hospitalet de Llobregat, , Spain

Site Status

Teva Investigational Site 780

Madrid, , Spain

Site Status

Teva Investigational Site 783

Seville, , Spain

Site Status

Teva Investigational Site 884

Liverpool, , United Kingdom

Site Status

Teva Investigational Site 882

London, , United Kingdom

Site Status

Teva Investigational Site 881

Sheffield, , United Kingdom

Site Status

Teva Investigational Site 883

Stoke-on-Trent, , United Kingdom

Site Status

Countries

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Czechia Germany Hungary Israel Italy Poland Russia Spain United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LAQ/5063

Identifier Type: OTHER

Identifier Source: secondary_id

2005-004334-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LAQ/5063OL

Identifier Type: -

Identifier Source: org_study_id

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