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
- Conditions
- aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 9.1Level: PTClassification code 10063399
- Registration Number
- EUCTR2009-015815-42-IT
- Lead Sponsor
- Teva Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1245
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 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: See Main objective;Primary end point(s): There is no primary endpoint in this study. The statistical analyses of this study will be exploratory in nature. Summary statistics will be prepared for demographic, safety and efficacy variables.
- Secondary Outcome Measures
Name Time Method