Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00200655
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis	Drug: Pravastatin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled Study
• Study Start Date: Dec 1, 2004
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

1. Number of gadolinium positive lesions at month 6 in each group. [at month 6 in each group]

Secondary Outcome Measures

1. Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up [after 6 months of follow-up]

2. Number of new T2 lesions []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Philippe DAMIER, MD, Nantes UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00200655
• Other Study ID Numbers: BRD/03/10-I-1
• First Posted: Sep 20, 2005
• Last Update Posted: Apr 28, 2016
• Last Verified: Jun 1, 2008

• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Pravastatin

Study Results

No Results Posted as of Apr 28, 2016