Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1 Level: PT Classification code 10028245
Conditions
Interventions
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
Pharmaceutical Form: Tablet
INN or Proposed INN: laquinimod
CAS Number: 248282-07-7
Current Sponsor code: ABR-215062 sodium
Sponsors
Teva Pharmaceutical Industries Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have a confirmed MS diagnosis as defined by the McDonald criteria (Ann Neurol, July 2001). 2. Subjects must have an R-R MS disease course. 3. Subjects must have at least one documented relapse in the 12 months prior to screening. 4. Subjects must have at least one gadolinium-enhanced (Gd; gadopentetic acid) lesion on their screening MRI scan. 5. Subjects must be ambulatory with a Kurtzke EDSS score of 1.0-5.0 (converted). 6. Subjects must be between 18-50 years of age, inclusive. 7. Subjects must be relapse-free and off corticosteroids or ACTH for at least 30 days prior to the MRI scan at screening. 8. Subjects must be relapse-free and off corticosteroids between screening and randomization (baseline V0). 9. Women of child-bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices and diaphragms with spermicide; oral contraception must be accompanied by an additional method of birth control.) 10. Subjects must be willing and able to comply with the protocol requirements for the duration of the study. 11. Subjects must be able to give signed, written, informed consent prior to entering the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who suffer from any form of progressive MS. 2. Use of immunosuppressive or cytotoxic treatments within 6 months prior to the screening visit (including azathioprine, cyclophosphamide methotrexate). 3. Use of experimental drugs, and/or participation in drug clinical studies within the 6 months prior to screening. 4. Previous treatment with immunomodulators (including IFNß 1a and 1b glatiramer acetate, laquinimod and IVIG) within the 2 months prior to screening. 5. Use of potent inhibitors of CYP3A4, such as oral ketoconazole or erythromycin within 2 weeks prior to baseline visit (see full list in Appendix 6). 6. Previous use of amiodarone. 7. Use of fluoxetine one month prior to baseline visit. 8. Use of the following substrates of CYP1A2: theophylline and warfarin within 2 weeks prior to screening. 9. Previous treatment with cladribine within the last 2 years prior to screening visit. 10. Subjects for whom potential immunosuppression would be contraindicated, for example: Hepatitis B/C or HIV. 11. Previous total body irradiation or total lymphoid irradiation. 12. Chronic corticosteroid treatment (30 or more consecutive days) within the 2 months prior to screening. 13. Pregnancy or breastfeeding. 14. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests, chest X-ray. 15. The subject's inability to give informed consent, or to complete the study, or if the subject is considered by the investigator to be, for any reason, an unsuitable candidate for this study. 16. A known history of sensitivity to Gd. 17. Inability to successfully undergo MRI scanning.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, tolerability and safety of two doses of laquinimod compared to placebo in R-R MS subjects, as measured by Magnetic Resonance Imaging (MRI) and clinical parameters;Secondary Objective: ;Primary end point(s): The cumulative number of enhancing lesions on T1-weighted images taken on weeks 12, 16, 20, 24, 28, 32 and 36 (primary end point). | — |
Countries
Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed