A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.

A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012989-30-GB

Enrollment

542

Registered

2009-07-13

Start date

2009-11-17

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 Pharmaceutical Form: Capsule, hard INN or Proposed INN: laquinimod CAS Nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol. 2. Women of child-bearing potential (for example women who are not postmenopausal or surgically sterilized) must practice two 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 include: intrauterine devices, barrier methods (condom or diaphragm with spermicide), and hormonal methods of birth control (e.g. oral contraceptive, contraceptive patch, and long-acting injectable contraceptive)]. 3.Subjects must be willing and able to comply with the protocol requirements for the duration of the study. 4.Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 542 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.Premature discontinuation from the MS-LAQ-301 study, for any reason. 2.Pregnancy [according to urine dipstick ß-HCG test performed at Baseline (Month 0E) visit] or breastfeeding. 3.Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study. 4.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).

Design outcomes

Primary

Measure	Time frame
Main Objective: To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis;Secondary Objective: Not applicable; Primary end point(s): There is no primary endpoint in this study. The statistical analyses of this study will be exploratory in nature. The outcome measures are as follows: 1.To assess the long-term safety and tolerability of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis. Safety and Tolerability Outcome Measures: Safety: ?Adverse events ?Vital signs ?ECG findings ?Clinical laboratory parameters Tolerability: ?Proportion of subjects (%) who prematurely discontinued from the study, reason of discontinuation and the time to withdrawal. ?Proportion of subjects (%) who prematurely discontinued from the study due to AEs and the time to withdrawal 2.To assess the long-term effect of laquinimod 0.6 mg on disease course, as assessed by several parameters: ?Number of confirmed relapses ?Progression of disability as measured by the EDSS score (including FS and AI) ?Progression of disability as measured by the MSFC score ?Binocular low-contrast visual acuity using the 100%, 2.5% and 1.25% contrast level charts [Sloan letter (Appendix 9) or Tumbling-E (Appendix 10)] ?Subject-reported fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) ; Timepoint(s) of evaluation of this end point: Number of confirmed relapses: -On-Study Relapse Evaluation throughout the treatment duratio	—

Measure

Time frame

Main Objective: To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis;Secondary Objective: Not applicable; Primary end point(s): There is no primary endpoint in this study. The statistical analyses of this study will be exploratory in nature. The outcome measures are as follows: 1.To assess the long-term safety and tolerability of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis. Safety and Tolerability Outcome Measures: Safety: ?Adverse events ?Vital signs ?ECG findings ?Clinical laboratory parameters Tolerability: ?Proportion of subjects (%) who prematurely discontinued from the study, reason of discontinuation and the time to withdrawal. ?Proportion of subjects (%) who prematurely discontinued from the study due to AEs and the time to withdrawal 2.To assess the long-term effect of laquinimod 0.6 mg on disease course, as assessed by several parameters: ?Number of confirmed relapses ?Progression of disability as measured by the EDSS score (including FS and AI) ?Progression of disability as measured by the MSFC score ?Binocular low-contrast visual acuity using the 100%, 2.5% and 1.25% contrast level charts [Sloan letter (Appendix 9) or Tumbling-E (Appendix 10)] ?Subject-reported fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) ; Timepoint(s) of evaluation of this end point: Number of confirmed relapses: -On-Study Relapse Evaluation throughout the treatment duratio

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria, Bulgaria, Canada, Czech Republic, Estonia, France, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Trial Information desk

Teva GmbH

info.era-clinical@teva.de000000000000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026