Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
Relapsing Remitting Multiple Sclerosis
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.
Interventions
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of brain lesions in the last 4 months of the study | 36 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Relapse rate | 36 weeks |
Outcome results
None listed