Status:
COMPLETED
Atorvastatin in Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
German Research Foundation
German Federal Ministry of Education and Research
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 scler...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00616187
Start Date
October 1 2003
Last Update
March 20 2018
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