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
- Conditions
- Multiple Sclerose10012303
- Registration Number
- NL-OMON43625
- Lead Sponsor
- TEVA Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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 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-301 study
1)Premature discontinuation from the MS-LAQ-301 study, for any reason
2)Pregancy [according to urine dipstick β-HCG test perfomed at Baseline (Month 0E) visit] or breastfeeding.
3)Subjects with clinically significant or unstable medical or surgical condition detected or worsened during MS-LAQ-301 study, which preclude safe partcipation 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>As this study is a single arm study, all statistical analysis will be<br /><br>descriptive in nature.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>