Atorvastatin in Relapsing-Remitting Multiple Sclerosis
Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing Remitting Multiple Sclerosis
Intervention: interferon beta treatment to add-on atorvastatin treatment (Drug); untreated to atorvastatin treatment (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Frauke Zipp, MD, Principal Investigator, Affiliation: Cecilie Vogt Clinic for Neurology, Charite, Berlin
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.
Clinical Details
Official title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: number of MRI contrast enhancing lesions
Secondary outcome: 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)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2003
Last updated: February 14, 2008
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