Relapsing Remitting Multiple SclerosisPhase 3irmsrctNCT00668343
Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo
A Phase 3 study testing simvastatin in people with Relapsing Remitting Multiple Sclerosis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Apr 2005to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- edss<5
- >=1 attack in last year
Who cannot join
- >2 attacks in study
- drug complication
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- simvastatin, placebo
- Keywords
- edss attack
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
40 mg/ day
placeboDrug
80 mg /day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: simvastatin |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
attack number
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2005
- Primary completionMar 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mansooreh Togha, MD, Principal investigator, TUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668343
- Sponsor's protocol ID
- 132/9388
- Other IDs
- 83/132/9388
- Acronym
- irmsrct
- Status last verified
- Jul 2010
- First submitted
- 27 Apr 2008
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20488825
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo
- ClinicalTrials.gov ID
- NCT00668343
- Acronym / sponsor ID
- irmsrct / 132/9388
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- edss attack
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: simvastatin |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- edss<5
- >=1 attack in last year
Key exclusion criteria (2 listed)
- >2 attacks in study
- drug complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simvastatin40 mg/ day | Drug | 1 |
| placebo80 mg /day | Drug | 2 |
Primary outcome
attack number
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
- Derived from this study: PubMed 20488825Togha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansooreh Togha, MD principal investigator
TUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing simvastatin in people with Relapsing Remitting Multiple Sclerosis, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
attack number (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00668343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2010; AzTrials last refreshed its copy on 31 Oct 2026.