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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668343
First Posted: April 29, 2008
Last Update Posted: July 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tehran University of Medical Sciences
  Purpose
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: Quadruple (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

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: April 27, 2008
First Posted: April 29, 2008
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