ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Atorvastatin in Relapsing-Remitting Multiple Sclerosis | |||
| Official Title ICMJE | Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Relapsing Remitting Multiple Sclerosis | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | 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. doi: 10.1371/journal.pone.0001928. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 41 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | Not Provided | |||
| Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00616187 | |||
| Other Study ID Numbers ICMJE | 1931/Si.270 am 8.5.03 ATV-D-03-007G | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Professor Frauke Zipp, Cecilie Vogt Clinic for Neurology, Charite University, Berlin, Germany | |||
| Study Sponsor ICMJE | Charite University, Berlin, Germany | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Charite University, Berlin, Germany | |||
| Verification Date | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||