EUCTR2009-015815-42-ITActive, not recruitingPhase 1
A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) 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 - ND
Teva Pharmaceutical Industries Ltd0 sites1,245 target enrollmentStarted: March 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,245
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 protocol. 2.Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner s vasectomy or double-barrier method (condom or diaphragm with spermicide)] 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-302E 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
- •1.Premature discontinuation from the MS-LAQ-302 study, for any reason. 2.Pregnancy [according to urine dipstick β-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-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E study. 4.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Investigators
Similar Trials
Active, not recruiting
Phase 1
A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) 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 -aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 9.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2009-015815-42-SKTeva Pharmaceutical Industries Ltd1,245
Active, not recruiting
Phase 1
A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-012989-30-EETeva Pharmaceutical Industries Ltd542
Active, not recruiting
Phase 1
A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-012989-30-CZTeva Pharmaceutical Industries Ltd542
Active, not recruiting
Phase 1
A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-012989-30-LTTeva Pharmaceutical Industries Ltd542
Active, not recruiting
Phase 1
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 - NDRelapsing - Remitting Multiple SclerosisMedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2009-012989-30-ITTeva Pharmaceutical Industries Ltd1,000