Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis (SIMCOMBIN)

Biogen

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Treatments

Drug: Placebo

Drug: Interferon-beta-1a

Drug: Simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00492765

SIMCOMBIN

Details and patient eligibility

About

This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.

Full description

This is a multi-centre, double blind, placebo controlled, randomised, parallel group, phase 4 study. Following three months treatment with Interferon beta 1a (Avonex) patients will be randomised for treatment with simvastatin or placebo as an add-on to interferon -beta-1a (AvonexÒ). Patients will start treatment with 40 mg peroral simvastatin daily or identically appearing placebo for one month. Hereafter, patients will escalate dosage to 80 mg daily. The patients will be examined clinically at baseline and at, 3, 4, 6, 9, 12 and 15 months. Patients who attend visit 5 (15 months) before the last patient has attended this visit will be asked to attend additional visits (visits 6+) until the last patient has attended visit 5. Clinical examination will be performed, for applicable patients, at 3 month intervals until the end of the study. This will be a maximum of two years, i.e. no more than eight additional visits. Laboratory assessments will be performed at screening 3, 4, 6, 9, 12 and 15 months after baseline, and for applicable patients additionally at 3 month intervals until end of study. MRI will be performed (T1-weighted and T2-weighted) at randomisation (3 months after baseline) and 12 months hereafter.

Enrollment

380 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Is between the age of 18 and 55 years (both included)
Relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) 22 or definite MS according to McDonald criteria 23
Disability equivalent to an EDSS of 5.5 or less 21
Clinical activity defined as at least one reported or documented relapse within the last year
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to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn

Exclusion criteria

Any condition that might give rise to similar symptoms as MS
Immunomodulatory or immunosuppressive treatment for MS prior to inclusion into the study (prior pulse steroid treatment for relapses is allowed)
Treatment with glucocorticoids or ACTH later than one month prior to inclusion into the study, i.e. at the screening visit
Onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit
History of major depression
Alcohol or drug dependency
Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
Significant hypertension (BP > 180/110 mmHg)
Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
Total plasma cholesterol < 3.5 mmol/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