A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
Phase 2
Completed
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT00349193
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.
The duration of the current study is 36 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
Inclusion Criteria
- Willing and able to give written informed consent
- Confirmed MS diagnosis as defined by the McDonald criteria
- R-R MS disease course.
- At least one gadolinium-enhanced lesion on screening MRI
- Women of child-bearing potential must practice a reliable method of birth control.
- Must understand the requirements of the study and agree to comply with the study protocol.
Exclusion Criteria
- Subjects who suffer from any form of progressive MS.
- Any condition which the investigator feels may interfere with participation in the study.
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
- Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
- Previous treatment with immunomodulators within two months prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laquinimod 0.3 mg laquinimod 0.3 Laquinimod 0.3 mg Laquinimod 0.6 mg laquinimod 0.6 Laquinimod 0.6 mg Placebo Placebo Blinded Placebo
- Primary Outcome Measures
Name Time Method Reduction of brain lesions in the last 4 months of the study 36 weeks
- Secondary Outcome Measures
Name Time Method Relapse rate 36 weeks