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Atorvastatin in Relapsing-Remitting Multiple Sclerosis

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
interferon beta treatment to add-on atorvastatin treatment
untreated to atorvastatin treatment
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    interferon

    untreated

    Arm Description

    Outcomes

    Primary Outcome Measures

    number of MRI contrast enhancing lesions

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    February 5, 2008
    Last Updated
    March 19, 2018
    Sponsor
    Charite University, Berlin, Germany
    Collaborators
    German Research Foundation, German Federal Ministry of Education and Research, Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00616187
    Brief Title
    Atorvastatin in Relapsing-Remitting Multiple Sclerosis
    Official Title
    Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2003 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Charite University, Berlin, Germany
    Collaborators
    German Research Foundation, German Federal Ministry of Education and Research, Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsing Remitting Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    interferon
    Arm Type
    Active Comparator
    Arm Title
    untreated
    Arm Type
    Sham Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    interferon beta treatment to add-on atorvastatin treatment
    Intervention Description
    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
    Intervention Name(s)
    untreated to atorvastatin treatment
    Intervention Description
    no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
    Primary Outcome Measure Information:
    Title
    number of MRI contrast enhancing lesions
    Time Frame
    treatment months 6 to 9 compared to baseline
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frauke Zipp, MD
    Organizational Affiliation
    Cecilie Vogt Clinic for Neurology, Charite, Berlin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18398457
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Atorvastatin in Relapsing-Remitting Multiple Sclerosis

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