Atorvastatin in Relapsing-Remitting Multiple Sclerosis

March 19, 2018 updated by: Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: interferon
Drug: 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)
SHAM_COMPARATOR: untreated
Drug: untreated to atorvastatin treatment
no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
treatment months 6 to 9 compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Research Foundation
Pfizer
German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Frauke Zipp, MD, Cecilie Vogt Clinic for Neurology, Charite, Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (ESTIMATE)

February 15, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1931/Si.270 am 8.5.03
  • ATV-D-03-007G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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