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

NCT00745615 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: LAQ/5063OLLAQ/50632005-004334-41
• Study Type: interventional
• Target: 257
• Locations: 9 countries
• Sites: 45

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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)

Secondary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• Double-Blind Period: Volume of T2 Lesions

  At the end of active double-blind phase or termination/early termination visit (up to Week 36)

Study Arms (6)

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.

Drug: Laquinimod

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.

Drug: Laquinimod

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.

Drug: Laquinimod; Drug: Placebo

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.

Drug: Laquinimod; Drug: Placebo

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).

Drug: Laquinimod

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).

Drug: Laquinimod

Interventions

Laquinimod DRUG

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

Also known as: TV-5600

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 0.6 mg; Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg

Placebo DRUG

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

Double-Blind: Placebo/Laquinimod 0.3 mg; Double-Blind: Placebo/Laquinimod 0.6 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Teva Pharmaceutical Industries, Ltd.: lead

Study Sites (45)

Teva Investigational Site 382

Hradec Králové, Czechia

Location

Teva Investigational Site 380

Prague, Czechia

Location

Teva Investigational Site 384

Praha 5- Motol, Czechia

Location

Teva Investigational Site 681

Berlin, Germany

Location

Teva Investigational Site 684

Erfurt, Germany

Location

Teva Investigational Site 687

Hamburg, Germany

Location

Teva Investigational Site 683

Mainz, Germany

Location

Teva Investigational Site 686

Ulm, Germany

Location

Teva Investigational Site 685

Würzburg, Germany

Location

Teva Investigational Site 580

Debrecen, Hungary

Location

Teva Investigational Site 581

Gyula, Hungary

Location

Teva Investigational Site 583

Miskolc, Hungary

Location

Teva Investigational Site 584

Veszprém, Hungary

Location

Teva Investigational Site 981

Ramat Gan, IL, Israel

Location

Teva Investigational Site 982

Haifa, Israel

Location

Teva Investigational Site 980

Jerusalem, Israel

Location

Teva Investigational Site 483

Cagliari, Italy

Location

Teva Investigational Site 484

Milan, Italy

Location

Teva Investigational Site 486

Milan, Italy

Location

Teva Investigational Site 488

Siena, Italy

Location

Teva Investigational Site 281

Bydgoszcz, Poland

Location

Teva Investigational Site 280

Katowice, Poland

Location

Teva Investigational Site 285

Katowice, Poland

Location

Teva Investigational Site 283

Lodz, Poland

Location

Teva Investigational Site 284

Lublin, Poland

Location

Teva Investigational Site 282

Wroclaw, Poland

Location

Teva Investigational Site 186

Moscow, Russia

Location

Teva Investigational Site 187

Moscow, Russia

Location

Teva Investigational Site 188

Moscow, Russia

Location

Teva Investigational Site 189

Moscow, Russia

Location

Teva Investigational Site 180

Saint Petersburg, Russia

Location

Teva Investigational Site 181

Saint Petersburg, Russia

Location

Teva Investigational Site 182

Saint Petersburg, Russia

Location

Teva Investigational Site 184

Saint Petersburg, Russia

Location

Teva Investigational Site 185

Saint Petersburg, Russia

Location

Teva Investigational Site 782

Barakaldo, Spain

Location

Teva Investigational Site 785

Barcelona, Spain

Location

Teva Investigational Site 781

Bilbao, Spain

Location

Teva Investigational Site 784

L'Hospitalet de Llobregat, Spain

Location

Teva Investigational Site 780

Madrid, Spain

Location

Teva Investigational Site 783

Seville, Spain

Location

Teva Investigational Site 884

Liverpool, United Kingdom

Location

Teva Investigational Site 882

London, United Kingdom

Location

Teva Investigational Site 881

Sheffield, United Kingdom

Location

Teva Investigational Site 883

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

laquinimod

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Giancarlo Comi

  Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: December 7, 2005
• Primary Completion: July 23, 2017
• Study Completion: July 23, 2017
• Last Updated: March 27, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-03

Locations

IL (3); DE (6); IT (4); HU (4); PL (6); ES (6); RU (9); CZ (3); GB (4)