Atorvastatin in Relapsing-Remitting Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00616187
• Date of registration: 05/02/2008
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Atorvastatin in Relapsing-Remitting Multiple Sclerosis
• Scientific title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
• Date of first enrolment: October 2003
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00616187
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Contacts

• Name: Frauke Zipp, MD
• Affiliation: Cecilie Vogt Clinic for Neurology, Charite, Berlin

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: interferon beta treatment to add-on atorvastatin treatment

Drug: untreated to atorvastatin treatment

Primary Outcome(s)

number of MRI contrast enhancing lesions [Time Frame: treatment months 6 to 9 compared to baseline]

Secondary Outcome(s)

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) [Time Frame: treatment months 6 to 9 compared to baseline]

Secondary ID(s)

ATV-D-03-007G

1931/Si.270 am 8.5.03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

German Research Foundation

Pfizer

German Federal Ministry of Education and Research