Clinical trial NCT00616187: Atorvastatin in Relapsing-Remitting Multiple Sclerosis
Official title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: German Federal Ministry of Education and Research
name: Pfizer
First posted: 2008-02-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: number of MRI contrast enhancing lesions
timeFrame: treatment months 6 to 9 compared to baseline
Secondary outcomes:
measure: other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter)
timeFrame: treatment months 6 to 9 compared to baseline
Other outcomes:
Locations:
Study officials:
affiliation: Cecilie Vogt Clinic for Neurology, Charite, Berlin
name: Frauke Zipp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dorr J, Waiczies H, Haertle M, Wernecke KD, Volk HD, Aktas O, Zipp F. Oral high-dose atorvastatin treatment in relapsing-remitting multiple sclerosis. PLoS One. 2008 Apr 9;3(4):e1928. doi: 10.1371/journal.pone.0001928.