Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis

NCT00200655 | Completed Phase 3

• 1 other identifier: BRD/03/10-I-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of gadolinium positive lesions at month 6 in each group.

  at month 6 in each group

Secondary Outcomes (2)

• Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up

  after 6 months of follow-up

• Number of new T2 lesions

Interventions

Pravastatin DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Philippe DAMIER, MD

  Nantes UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2004
• Study Completion: November 1, 2007
• Last Updated: April 28, 2016

Record last verified: 2008-06

Locations

FR (1)