A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries

Criteria

Inclusion Criteria:

1. Willing and able to give written informed consent

2. Confirmed MS diagnosis as defined by the McDonald criteria

3. R-R MS disease course.

4. At least one gadolinium-enhanced lesion on screening MRI

5. Women of child-bearing potential must practice a reliable method of birth control.

6. Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

1. Subjects who suffer from any form of progressive MS.

2. Any condition which the investigator feels may interfere with participation in the study.

3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,

4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening

5. Previous treatment with immunomodulators within two months prior to screening