Atorvastatin in Relapsing-Remitting Multiple Sclerosis

NCT00616187

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Relapsing Remitting Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Relapsing Remitting Multiple SclerosisAtorvastatin in Relapsing-Remitting Multiple Sclerosis
NCT00616187
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Drug: interferon beta treatment to add-on atorvastatin treatment
    IFN-?-1a 22 µg s.c. 3 times weekly or IFN-?-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
  • Drug: untreated to atorvastatin treatment
    no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
Study Arms  ICMJE
  • Active Comparator: interferon
    Intervention: Drug: interferon beta treatment to add-on atorvastatin treatment
  • Sham Comparator: untreated
    Intervention: Drug: untreated to atorvastatin treatment
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
 (submitted: February 14, 2008)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • German Research Foundation
  • German Federal Ministry of Education and Research
  • Pfizer
Investigators  ICMJE
Principal Investigator:Frauke Zipp, MDCecilie Vogt Clinic for Neurology, Charite, Berlin
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