Atorvastatin in Relapsing-Remitting Multiple Sclerosis
Atorvastatin in Relapsing-Remitting Multiple Sclerosis
A phase II open-label baseline-to-treatment trial was designed to evaluate the safety,
 tolerability and efficacy of orally administered atorvastatin in patients with
 relapsing-remitting multiple sclerosis (RRMS). Patients with at least one
 gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were
 eligible for the study. Patients are screened and enrolled in the outpatient clinic of the
 Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3
 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg
 atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9
 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in
 clinical scores and immune responses.
Inclusion Criteria:

 -  18 - 55 years old

 -  MS diagnosis according McDonald criteria

 -  Relapsing-remitting MS

 -  EDSS 0 - 6

 -  Disease activity as occurrence of CEL in brain MRI

 -  IFN-beta therapy for at least 6 months

 Exclusion Criteria:

 -  Primary chronic progressive MS

 -  Symptoms and signs of clinical disease conditions similar to MS

 -  Conditions that can disturb MRI measurements

 -  Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus
 pepticum

 -  Clinically relevant lung, heart, CNS, infectious disease

 -  Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific
 clinical chemistry values)

 -  Allergies towards Gd-DTPA

 -  Allergies towards constituents of the therapeutic agent

 -  Recruitment to other clinical trials within 6 months prior to or during this study

 -  Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte
 populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A,
 human antibodies, all immunomodulatory or immunosuppressive agents including
 recombinant cytokines or other potential experimental MS therapies (6 months prior to
 study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start)
 pregnancy or lactation

 -  Alcohol or drug abuse

 -  Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole
 antimycotics).

 -  Medical or psychological conditions that could hamper with the patients capacity to
 understand patient information, to give the informed consent, to adhere to the
 protocol of the study and to be able to complete the study