Atorvastatin in Relapsing-Remitting Multiple Sclerosis

NCT ID: NCT00616187

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interferon

Group Type: ACTIVE_COMPARATOR

interferon beta treatment to add-on atorvastatin treatment

Intervention Type: DRUG

IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)

untreated

Group Type: SHAM_COMPARATOR

untreated to atorvastatin treatment

Intervention Type: DRUG

no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)

Interventions

interferon beta treatment to add-on atorvastatin treatment

IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)

Intervention Type: DRUG

untreated to atorvastatin treatment

no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Cecilie Vogt Clinic for Neurology, Charite University, Berlin, Germany

Principal Investigators

Frauke Zipp, MD

Role: PRINCIPAL_INVESTIGATOR

Cecilie Vogt Clinic for Neurology, Charite, Berlin

References

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.

Reference Type: DERIVED

PMID: 18398457 (View on PubMed)

Other Identifiers

ATV-D-03-007G

Identifier Type: -

Identifier Source: secondary_id

1931/Si.270 am 8.5.03

Identifier Type: -

Identifier Source: org_study_id