Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - -

• Register: EUCTR
• Last refreshed on: 29 May 2017
• Main ID: EUCTR2009-012989-30-ES
• Date of registration: 05/08/2009
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries Ltd
• Public title: Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - -
• Scientific title: Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - -
• Date of first enrolment: 21/10/2009
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012989-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Spain, Sweden, United Kingdom

Key inclusion & exclusion 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 must practice an acceptable method of birth control during the study and up to 30 days after the last dose of the study drug.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion Criteria:
1.Premature discontinuation from the MS-LAQ-301 study, for any reason.
2.Pregnancy [according to urine dipstick ?-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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Esclerosis Múltiple Remitente Recurrente (RRMS).
MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis

Intervention(s)

Product Name: Laquinimod Capsulas 0.6 mg
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: ABR-215062 sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-

Primary Outcome(s)

Secondary Objective: -

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

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)

Secondary ID(s)

2009-012989-30-GB

MS-LAQ-301E