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

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ClinicalTrials.gov Identifier: NCT00668343
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : July 30, 2010
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: simvastatin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: simvastatin
40 mg/ day
Placebo Comparator: 2 Drug: placebo
80 mg /day



Primary Outcome Measures :
  1. attack number [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. >2 attacks in study
  2. drug complication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668343


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: mansoureh togha, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00668343     History of Changes
Other Study ID Numbers: 132/9388
83/132/9388
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: July 2010

Keywords provided by Tehran University of Medical Sciences:
edss attack

Additional relevant MeSH terms:
Sclerosis
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
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors