E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Relapsing Remitting Multiple Sclerosis | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 5.1 | E.1.2 | Level | PT | E.1.2 | Classification code | 10028245 | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | 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 | |
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. | |
E.4 | Principal 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 IFNβ 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. | |
E.5 End points |
E.5.1 | 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). | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |