Atorvastatin in Relapsing-Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616187
• Other study ID #: 1931/Si.270 am 8.5.03
• Secondary ID: ATV-D-03-007G
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2008
• Last updated: March 19, 2018
• Start date: October 2003

Study information

• Verified date: December 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• interferon beta treatment to add-on atorvastatin treatment
IFN-ß-1a 22 µg s.c. 3 times weekly or IFN-ß-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
• untreated to atorvastatin treatment
no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research, German Research Foundation, Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of MRI contrast enhancing lesions		treatment months 6 to 9 compared to baseline
Secondary	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)		treatment months 6 to 9 compared to baseline