NCT00668343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 30, 2010

Status Verified

July 1, 2010

Enrollment Period

2.9 years

First QC Date

April 27, 2008

Last Update Submit

July 29, 2010

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

edss attack

Outcome Measures

Primary Outcomes (1)

  • attack number

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: simvastatin

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

simvastatinDRUG

40 mg/ day

1
placeboDRUG

80 mg /day

2

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • edss\<5
  • \>=1 attack in last year

You may not qualify if:

  • \>2 attacks in study
  • drug complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanaz Ahmadi

Tehran, 0098, Iran

Location

Related Publications (1)

  • 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.

    PMID: 20488825DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Mansooreh Togha, MD

    TUMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2008

First Posted

April 29, 2008

Study Start

April 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2009

Last Updated

July 30, 2010

Record last verified: 2010-07

Locations

IR(1)