Status:
COMPLETED
A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 redu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00349193
Start Date
March 1 2005
End Date
August 1 2006
Last Update
April 8 2011
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