Safety and Efficacy of Pravastatin in Relapsing-Remitting Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200655
First received: September 12, 2005
Last updated: June 6, 2008
Last verified: June 2008

September 12, 2005
June 6, 2008
December 2004
Not Provided
Number of gadolinium positive lesions at month 6 in each group. [ Time Frame: at month 6 in each group ]
Number of gadolinium positive lesions at month 6 in each group.
Complete list of historical versions of study NCT00200655 on ClinicalTrials.gov Archive Site
  • Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up [ Time Frame: after 6 months of follow-up ]
  • Number of new T2 lesions
  • Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up
  • Number of new T2 lesions
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Not Provided
 
Safety and Efficacy of Pravastatin in Relapsing-Remitting Multiple Sclerosis
Safety and Efficacy of Pravastatin in Relapsing-Remitting MS: a Double Blind Placebo Controlled Study

Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins"). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Drug: Pravastatin
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2007
Not Provided

Inclusion Criteria:

  • Relapsing remitting MS with diagnosis defined by the McDonald criteria (McDonald et al., 2001) with no current disease modifying therapy (interferon, copaxone or immunosuppressant drugs) since at least 3 months and an EDSS score < 5.
  • At least one gadolinium positive lesion on the MRI of the selection phase is needed.
  • No current statin therapy.
  • Normal renal and hepatic biological tests.
  • No current pregnancy
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00200655
BRD/03/10-I
No
Not Provided
Nantes University Hospital
Not Provided
Principal Investigator: Philippe DAMIER, MD Nantes UH
Nantes University Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP