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

This study has been completed.
Information provided by:
Tehran University of Medical Sciences Identifier:
First received: April 27, 2008
Last updated: July 29, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: simvastatin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • attack number [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2005
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: simvastatin
40 mg/ day
Placebo Comparator: 2 Drug: placebo
80 mg /day


Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. >2 attacks in study
  2. drug complication
  Contacts and Locations
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Please refer to this study by its identifier: NCT00668343

Iran, Islamic Republic of
Sanaz Ahmadi
Tehran, Iran, Islamic Republic of, 0098
Sponsors and Collaborators
Tehran University of Medical Sciences
Principal Investigator: Mansooreh Togha, MD TUMS
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: mansoureh togha, Tehran University of Medical Sciences Identifier: NCT00668343     History of Changes
Other Study ID Numbers: 132/9388  83/132/9388 
Study First Received: April 27, 2008
Last Updated: July 29, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
edss attack

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016