Safety and Efficacy of Pravastatin in Relapsing-Remitting Multiple Sclerosis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing-Remitting Multiple Sclerosis |
Drug: Pravastatin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Pravastatin in Relapsing-Remitting MS: a Double Blind Placebo Controlled Study |
- Number of gadolinium positive lesions at month 6 in each group. [ Time Frame: at month 6 in each group ]
- 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
| Enrollment: | 40 |
| Study Start Date: | December 2004 |
| Study Completion Date: | November 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00200655 History of Changes |
| Other Study ID Numbers: | BRD/03/10-I |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 6, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Pravastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013