search
Back to results

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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
simvastatin
placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring edss attack

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. >2 attacks in study
  2. drug complication

Sites / Locations

  • Sanaz Ahmadi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

attack number

Secondary Outcome Measures

Full Information

First Posted
April 27, 2008
Last Updated
July 29, 2010
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00668343
Brief Title
Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo
Acronym
irmsrct
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
edss attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
simvastatin
Intervention Description
40 mg/ day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
80 mg /day
Primary Outcome Measure Information:
Title
attack number
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: edss<5 >=1 attack in last year Exclusion Criteria: >2 attacks in study drug complication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansooreh Togha, MD
Organizational Affiliation
TUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanaz Ahmadi
City
Tehran
ZIP/Postal Code
0098
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20488825
Citation
Togha M, Karvigh SA, Nabavi M, Moghadam NB, Harirchian MH, Sahraian MA, Enzevaei A, Nourian A, Ghanaati H, Firouznia K, Jannati A, Shekiba M. Simvastatin treatment in patients with relapsing-remitting multiple sclerosis receiving interferon beta 1a: a double-blind randomized controlled trial. Mult Scler. 2010 Jul;16(7):848-54. doi: 10.1177/1352458510369147. Epub 2010 May 20.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs