Optic NeuritisPhase 3NCT00261326
Simvastatin Treatment of Patients With Acute Optic Neuritis
A Phase 3 study testing simvastatin in people with Optic Neuritis and Multiple Sclerosis, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if the simvastatin treatment improve the visual function after 3 months of the inclusion to this project and if the simvastatin influences the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the development of new demyelinating relapses. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Optic Neuritis, Multiple Sclerosis
- What is being tested?
- simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to May 2011
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute Optic Neuritis
- Abnormal contrast sensitivity score (>80)
- Symptom duration maximum 4 weeks
- Men and women between 18 and 59 years old
- The patient must be physical and mental able to participate i this project with a 6 months of the duration
- The patient must sign the written consent of the participation before the inclusion.
Who cannot join
- Optic neuritis earlier in the same eye
- Pregnancy
- Nursing
- Fertile women who do not use contraception
- Women who contemplate pregnancy in the duration of the study
- Steroid treatment the last 4 weeks before the inclusion
Show all 16Show fewer
- Immune-supressor treatment the last 6 months before the inclusion
- Active liver disease or continuous increase of liver enzymes (ASAT, ALAT)without known reason.
- Kidney failure
- Myopathy
- Hyperthyroidism
- Diabetes mellitus
- Alcoholism
- Fibrates intake
- Statin treatment for other disease
- Simultaneous participation in other studies.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital
Glostrup Municipality, Glostrup, DK-2600
About this study
Official title: Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
The purpose of this study is to investigate if the simvastatin treatment improve the visual function after 3 months of the inclusion to this project and if the simvastatin influences the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the development of new demyelinating relapses. In the patients with monosymptomatic acut optic neuritis to investigate whether the simvastatin reduces the risk to develop multiple sclerosis (MS).
Read the detailed description
Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease in the Central Nervous System (CNS). Acute optic neuritis is a common symptom of MS and is considered to have the same pathogenesis as MS, where autoimmune and inflammatory mechanisms lead to the progression of MS.
Statins reduce the cholesterol in blood and in addition have anti-inflammatory effects. From experimental data and results from pilot projects there is evidence that the statins perform anti-inflammatory and immune-modulatory effects and one can expect a beneficial outcome in the autoimmune inflammatory diseases after the treatment with statins.
- Conditions
- Optic Neuritis, Multiple Sclerosis
- Being tested
- simvastatin, placebo
- Keywords
- Simvastatin, Optic Neuritis, Multiple Sclerosis
- Medical subject headings
- Optic Neuritis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
80 mg once daily
placeboDrug
calcium tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | simvastatin tablets 80 mg daily Receives: Drug: simvastatin |
| A | Placebo comparator | calcium tablets 80 mg Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The contrast sensibility of the eye after 3 months of the treatment
Measured: 6 months
Secondary outcomes (4)
Visual acuity
Measured: 6 months
visual evokes potentials (VEP)
Measured: 6 months
cerebral MRI
Measured: 6 months
Developing MS after 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startSep 2006
- Primary completionJan 2010 (estimated)
- Study completionMay 2011 (estimated)
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 Optic NeuritisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Alpharma ApS
- Investigators
- Jette L Frederiksen, Dr.Med, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261326
- Sponsor's protocol ID
- Statin-01
- Other IDs
- KA 04068gs
- Status last verified
- Mar 2009
- First submitted
- 2 Dec 2005
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsakiri A, Kallenbach K, Fuglo D, Wanscher B, Larsson H, Frederiksen J. Simvastatin improves final visual outcome in acute optic neuritis: a randomized study. Mult Scler. 2012 Jan;18(1):72-81. doi: 10.1177/1352458511415452. Epub 2011 Sep 15.
PubMed 21921071
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
- ClinicalTrials.gov ID
- NCT00261326
- Acronym / sponsor ID
- Statin-01
- Conditions
- Optic Neuritis, Multiple Sclerosis
- Keywords
- Simvastatin, Optic Neuritis, Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Alpharma ApS
- Study start
- Sep 2006
- Primary completion
- Jan 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 5 Dec 2005 (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.
The purpose of this study is to investigate if the simvastatin treatment improve the visual function after 3 months of the inclusion to this project and if the simvastatin influences the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the development of new demyelinating relapses. In the patients with monosymptomatic acut optic neuritis to investigate whether the simvastatin reduces the risk to develop multiple sclerosis (MS).
Detailed description
Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease in the Central Nervous System (CNS). Acute optic neuritis is a common symptom of MS and is considered to have the same pathogenesis as MS, where autoimmune and inflammatory mechanisms lead to the progression of MS.
Statins reduce the cholesterol in blood and in addition have anti-inflammatory effects. From experimental data and results from pilot projects there is evidence that the statins perform anti-inflammatory and immune-modulatory effects and one can expect a beneficial outcome in the autoimmune inflammatory diseases after the treatment with statins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: simvastatinsimvastatin tablets 80 mg daily |
| A | Placebo comparator | Drug: placebocalcium tablets 80 mg |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Acute Optic Neuritis
- Abnormal contrast sensitivity score (>80)
- Symptom duration maximum 4 weeks
- Men and women between 18 and 59 years old
- The patient must be physical and mental able to participate i this project with a 6 months of the duration
Key exclusion criteria (16 listed)
- Optic neuritis earlier in the same eye
- Pregnancy
- Nursing
- Fertile women who do not use contraception
- Women who contemplate pregnancy in the duration of the study
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 |
|---|---|---|
| simvastatin80 mg once daily | Drug | B |
| placebocalcium tablets once daily | Drug | A |
Primary outcome
The contrast sensibility of the eye after 3 months of the treatment
Time frame: 6 months
4 secondary outcomes
Visual acuity
Time frame: 6 months
visual evokes potentials (VEP)
Time frame: 6 months
cerebral MRI
Time frame: 6 months
Developing MS after 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
- Derived from this study: PubMed 21921071Tsakiri A, Kallenbach K, Fuglo D, Wanscher B, Larsson H, Frederiksen J. Simvastatin improves final visual outcome in acute optic neuritis: a randomized study. Mult Scler. 2012 Jan;18(1):72-81. doi: 10.1177/1352458511415452. Epub 2011 Sep 15.
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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.
Jette L Frederiksen, Dr.Med study director
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 Optic Neuritis and Multiple Sclerosis, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 10 Jan 2011. 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 Denmark. 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?
Results are not available in the source record.
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?
The contrast sensibility of the eye after 3 months of the treatment (time frame: 6 months). 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 NCT00261326, 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 10 Jan 2011.