Atorvastatin in Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsor:	Charite University, Berlin, Germany
Collaborators:	German Research Foundation German Federal Ministry of Education and Research Pfizer
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00616187

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Atorvastatin Atorvastatin calcium Interferons

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
interferon: Active Comparator	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)
untreated: Sham Comparator	Drug: untreated to atorvastatin treatment no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dörr 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.

Responsible Party:	Cecilie Vogt Clinic for Neurology, Charite University, Berlin, Germany ( Professor Frauke Zipp )
Study ID Numbers:	1931/Si.270 am 8.5.03, ATV-D-03-007G
Study First Received:	February 5, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00616187 History of Changes
Health Authority:	Germany: Federal Ministry for Health and Social Affairs Berlin(LaGeSo Berlin)

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases

Demyelinating Diseases
Antilipemic Agents
Interferons
Nervous System Diseases
Interferon-beta
Enzyme Inhibitors
Sclerosis
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antiviral Agents
Pharmacologic Actions
Demyelinating Autoimmune Diseases, CNS
Atorvastatin

ClinicalTrials.gov processed this record on February 08, 2010