Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo (irmsrct)

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: placebo; Drug: simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00668343

132/9388

83/132/9388

Details and patient eligibility

About

Patient with relapsing remitting multiple sclerosis taking avonex are included in this double blind randomized control trial. Simvastatin is compared to placebo. end points of edss , total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.

Enrollment: 80 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. edss<5
2. >=1 attack in last year

Exclusion criteria

1. >2 attacks in study
2. drug complication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: simvastatin

2

Placebo Comparator group

Treatment:

Drug: placebo