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Sponsors and Collaborators: |
Charite University, Berlin, Germany German Research Foundation German Federal Ministry of Education and Research Pfizer |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00616187 |
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
Condition | Intervention | Phase |
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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 |
Enrollment: | 41 |
Study Start Date: | October 2003 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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)
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untreated: Sham Comparator |
Drug: untreated to atorvastatin treatment
no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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
Principal Investigator: | Frauke Zipp, MD | Cecilie Vogt Clinic for Neurology, Charite, Berlin |
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) |
Antimetabolites Anti-Infective Agents Autoimmune Diseases Demyelinating Diseases Immunologic Factors Antilipemic Agents Interferons Interferon-beta Sclerosis |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Multiple Sclerosis, Relapsing-Remitting Antiviral Agents Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Atorvastatin |
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 Nervous System Diseases Interferon-beta Sclerosis Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Pharmacologic Actions Demyelinating Autoimmune Diseases, CNS Atorvastatin |