Atorvastatin in Relapsing-Remitting Multiple Sclerosis

Charité University Medicine Berlin

Status and phase

Completed

Phase 2

Conditions

Relapsing Remitting Multiple Sclerosis

Treatments

Drug: untreated to atorvastatin treatment

Drug: interferon beta treatment to add-on atorvastatin treatment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00616187

1931/Si.270 am 8.5.03

ATV-D-03-007G

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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