A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone

• Conditions: Multiple Sclerosis; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2006-001827-21-DK
• Lead Sponsor: Glostrup Hospital, Dep. of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

A patient may be included if s/he fulfils all criteria mentioned below:
The patient must give written informed consent prior to any study related activities. Study related activities are any procedures that would not have been performed during normal management of the patient.
Is between the age of 18 and 65 years (both included).
Suffers from definite relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) 21 or definite MS according to McDonald criteria 22.
Has a disability equivalent to an EDSS of 6.5 or less 20.
Has shown clinical activity
Has been treated with Copaxone for at least 3 months.
The patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The patient must not be included if any of the criteria mentioned below are fulfilled:
Any condition that might give rise to similar symptoms as MS.
Has received treatment with glucocorticoids or ACTH later than one month prior to inclusion into the study, i.e. at the screening visit.
Has experienced the onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit.
Has suffered from major depression.
Has received immuno-suppressive treatment in the 6 months prior to screening.
Alcohol or drug dependency.
Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV).
Significant hypertension (BP > 180/110 mmHg).
Has renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit.
ASAT and/or ALAT more than 1.5 times the normal upper reference limit.
Leucopaenia < 2.5 x 109/L or thrombopaenia < 100 x109/L.
Any medical illness requiring treatment with systemic corticosteroids.
Any systemic disease that can influence the patient’s safety and compliance, or the evaluation of the disability.
Women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception (contraceptive pill, intrauterine device, administration of deposit of progestins, subcutaneous implants, contraception ring, transdermal deposit plaster).
Known or suspected allergy to study product or related products.
Participation in any other studies, involving other investigational product, within 30 days prior to participating in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to estimate the effect of Copaxone with an add-on of simvastatin versus Copaxone with an add-on of placebo on:<br> Number of new and/or enlarging lesions on T2-weighted MRI based on MRI done 12 months following baseline compared with MRI done at baseline.<br><br>;Secondary Objective: to estimate the effect of Copaxone with an add-on of simvastatin versus Copaxone with an add-on of placebo on: <br>Changes in the EDSS score between baseline and 12 months after baseline.<br>Number of documented relapses after baseline.<br>Changes in immunological parameters<br>Regulation of immunological activation.<br><br>;Primary end point(s): To estimate the effect of Glatiramer acetate with an add-on of simvastatin versus Glatiramer acetate with an add-on of placebo on:<br>Number of new and/or enlarging lesions on T2-weighted MRI based on MRI done at 12 months compared with MRI done at baseline.<br>