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

NCT ID: NCT00668343

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Keywords

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edss attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

40 mg/ day

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

80 mg /day

Interventions

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simvastatin

40 mg/ day

Intervention Type DRUG

placebo

80 mg /day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. \>2 attacks in study
2. drug complication
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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Mansooreh Togha, MD

Role: PRINCIPAL_INVESTIGATOR

TUMS

Locations

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Sanaz Ahmadi

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 20488825 (View on PubMed)

Other Identifiers

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83/132/9388

Identifier Type: -

Identifier Source: secondary_id

132/9388

Identifier Type: -

Identifier Source: org_study_id