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Atorvastatin in Relapsing-Remitting Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616187
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Research Foundation
German Federal Ministry of Education and Research
Pfizer
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Drug: interferon beta treatment to add-on atorvastatin treatment Drug: untreated to atorvastatin treatment Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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

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

Enrollment: 41
Study Start Date: October 2003
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616187


Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
German Federal Ministry of Education and Research
Pfizer
Investigators
Principal Investigator: Frauke Zipp, MD Cecilie Vogt Clinic for Neurology, Charite, Berlin
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Frauke Zipp, Cecilie Vogt Clinic for Neurology, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00616187     History of Changes
Other Study ID Numbers: 1931/Si.270 am 8.5.03
ATV-D-03-007G
First Submitted: February 5, 2008
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Atorvastatin Calcium
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs