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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

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   (Child, Adult)
Sexes Eligible for Study:   All
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
Study First Received: April 27, 2008
Last Updated: July 29, 2010

Keywords provided by Tehran University of Medical Sciences:
edss attack

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on July 19, 2017