Multiple sclerosis treatment MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: TORVAST*10CPR 10MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Atorvastatin
CAS Number: 134523-03-8
Concentration unit: mg milligram(s)
Concentration number: 40-
Pharmaceu
Sponsors
DR DIMENSIONE RICERCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with relapsing-remitting forms of Multiple Sclerosis (according to McDonald s criteria; 28) with disease duration > 3 months and - 5 years. 2. EDSS score between 1.0 and 5.5, inclusive. 3. Currently treated with, and tolerating, Interferon beta, and having received this treatment for more than 3 and less than 12 months. 4. Age between 18 and 50 years, inclusive. 5. Patients must agree to avoid macrolids, including erytromicine and claritromicine for the whole study duration. 6. A woman of child-bearing potential must agree to adapt the proper behaviour adequately to avoid pregnancy while on study. 7. Negative pregnancy test results at screening day (all women of childbearing potential only). 8. Consent to go on the diet (appendix 2). 9. Written informed consent. 10. Serum lipid profile, as defined in appendix 3. 11. Adequate bone marrow, renal, and hepatic function, as defined in appendix 4. Are the trial subjects under 18? no Number of subjects for this age range: 0 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. Any disease other than Multiple Sclerosis that would better explain the patient s signs and symptoms. 2. Primary progressive MS. 3. Secondary progressive MS. 4. Uncontrolled, clinically significant heart diseases, such as dysrhythmias, angina, or uncompensated congestive heart failure. 5. Previous confirmed venous thromboembolic disease including deep vein phlebitis and/or pulmonary embolism or known hemostatic disorder predisposing to thromboembolic complications. 6. Uncontrolled Seizure disorder. 7. Myopathy or clinically significant liver disease. 8. Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study. 9. Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study. 10. Well-known hypersensitivity to either Atorvastatin or Interferon β or other human proteins including albumin.11. Well-known hypersensitivity to gadolinium. 12. Inability to undergo a MRI scan. 13. A relapse started within 30 days prior to screening or between screening and baseline. 14. A history of substance abuse (hard and soft drugs, alcoholic drinks) in the 90 days prior to screening. 15. Previous (at any time ) therapy with any of the following: monoclonal antibodies, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocoticotropic hormone; ACTH), total lymphoid irradiation. 16. Previous therapy, administrated for ≥12 months, with other interferon beta drugs, Mitoxantrone, Azathioprine or Glatiramer acetate in the 12 months before start of the currently interferon beta treatment.. 17. Previous treatment (at any time) with statins. 18. Treatment with any of the following in the 30 days before baseline: systemic corticosteroids, ACTH, or other investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of the study is the efficacy of Atorvastatin compared to placebo, in patients RRMS already in treatment with Interferon-beta, evaluating the disease activity measured by the changes in brain atrophy after 24 months of treatment.;Primary end point(s): The primary endpoint variable will be the changes in brain atrophy by brain MRI after 24 months.;Secondary Objective: 1.Clinical disease progression (EDSS, MSFC)2.Functional systems subscores of EDSS and MSFC 3.Cognitive performance by Rao battery tests4.Proportion of patients relapse-free after 12 and 24 months of treatment5.Relapse rate after 12 and 24 months of treatment6. Hazard rate of relapses7.Time to first relapse 8. Number of T1 lesions for each patient after 12 and 24 months of treatment 9. Number of T2 lesions for each patient after12 and 24 months of treatment10. New T2 lesions after 24 months 11.Number of Gd-enhancing lesion on T1-weighted images after 12 and 24 months of treatment12. Volume changes of total T2 lesions after 12 and 24 months of treatment13.Volume changes of total T1 lesions after 12 and 24 monthsoftreatment 14.Proportion of patients without increase of total lesion volume after 12 and 24 months of treatment 15.Changes in brain volume,(atrophy after 12months, grey matter and white matterafter12and24 months)16.NAband MxAtitles17Serum lipid levels18.Correlationof APOE | — |
Countries
Italy
Outcome results
None listed