Relapsing Remitting Multiple SclerosisPhase 3NCT00429442
Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis
A Phase 3 study testing Simvastatin in people with Relapsing Remitting Multiple Sclerosis, run by Anna Tsakiri at 1 site in Denmark.
Trial summary
A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 months Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Remitting 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
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A patient may be included if s/he fulfils all criteria mentioned below:
- The patient must give written informed consent prior to any study related activities. Study related activities are any procedures that would not have been performed during normal management of the patient.
- Is between the age of 18 and 60 years (both included).
- Suffers from definite relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) 21 or definite MS according to McDonald criteria 22.
- Has a disability equivalent to an EDSS of 6.5 or less 20.
- Has shown clinical activity defined as at least one reported or documented relapse within the last year or two reported or documented relapses within the last two years.
- Has been treated with Copaxone for at least 3 months.
- The patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn.
Who cannot join
- The patient must not be included if any of the criteria mentioned below are fulfilled:
- Any condition that might give rise to similar symptoms as MS.
- Has received treatment with glucocorticoids or ACTH later than one month prior to inclusion into the study, i.e. at the screening visit.
- Has experienced the onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit.
- Has suffered from major depression.
- Has received immuno-suppressive treatment in the 6 months prior to screening.
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- Alcohol or drug dependency.
- Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV).
- Significant hypertension (BP > 180/110 mmHg).
- Has renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit.
- ASAT and/or ALAT more than 1.5 times the normal upper reference limit.
- Leucopaenia < 2.5 x 109/L or thrombopaenia < 100 x109/L.
- Any medical illness requiring treatment with systemic corticosteroids.
- Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability.
- Women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception (contraceptive pill, intrauterine device, administration of deposit of progestins, subcutaneous implants, contraception ring, transdermal deposit plaster).
- Known or suspected allergy to study product or related products.
- Participation in any other studies, involving other investigational product, within 30 days prior to participating in this study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neurology, Glostrup University Hospital
Glostrup Municipality, Glostrup, 2600
About this study
Official title: A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in Patients Treated With Copaxone for at Least 3 Months
A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 months
Read the detailed description
This is a double blind, placebo controlled, randomised, phase 3 study. Patients that have been treated with Copaxone for at least 6 months at the screening visit will be randomised for treatment with simvastatin or placebo as an add-on to their Copaxone treatment. Patients will start treatment with 40 mg peroral simvastatin daily (or an apparently identical placebo) for one month. Hereafter, patients will escalate dosage to 80 mg daily. The patients will be examined clinically at screening, baseline and at 3, 6 and 12 months. Blood samples for immunology will be performed at baseline and at 1, 3, 6 and 12 months. Blood samples for safety assessments will be performed at all study visits. MRI will be performed (T1-weighted and T2-weighted) at baseline and at 6 and 12 months.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Simvastatin, placebo
- Keywords
- Simvastatin, CNS Inflammation, Copaxone
- 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
80 mg once daily
placeboDrug
calcium tablets once daily
| 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.
Number of new and/or enlarging lesions on T2- weighted MRI based on MRI done 12 months following baseline compared with MRI done at baseline.
Measured: one year
Secondary outcomes (5)
Changes in the EDSS score between baseline and 12 months after baseline.
Measured: one year
Changes in the MFSC score between baseline and 12 months after baseline.
Measured: one year
Number of documented relapses after baseline.
Measured: one year
Changes in immunological parameters
Measured: one year
Regulation of immunological activation.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startMar 2008
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Tsakiri
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Anna Tsakiri, Glostrup University Hospital, Copenhagen
- Investigators
- Jette L Frederiksen, DMSC, Principal investigator, Department of Neurology, Glostrup Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429442
- Sponsor's protocol ID
- CoSim-01
- Other IDs
- EudraCT number 2006-001827-21
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2007
- Last updated
- 20 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in Patients Treated With Copaxone for at Least 3 Months
- ClinicalTrials.gov ID
- NCT00429442
- Acronym / sponsor ID
- CoSim-01
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Simvastatin, CNS Inflammation, Copaxone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anna TsakiriUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Mar 2008
- Study completion
- Mar 2011 (estimated)
- First posted
- 31 Jan 2007 (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.
A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 months
Detailed description
This is a double blind, placebo controlled, randomised, phase 3 study. Patients that have been treated with Copaxone for at least 6 months at the screening visit will be randomised for treatment with simvastatin or placebo as an add-on to their Copaxone treatment. Patients will start treatment with 40 mg peroral simvastatin daily (or an apparently identical placebo) for one month. Hereafter, patients will escalate dosage to 80 mg daily. The patients will be examined clinically at screening, baseline and at 3, 6 and 12 months. Blood samples for immunology will be performed at baseline and at 1, 3, 6 and 12 months. Blood samples for safety assessments will be performed at all study visits. MRI will be performed (T1-weighted and T2-weighted) at baseline and at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Simvastatin |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- A patient may be included if s/he fulfils all criteria mentioned below:
Key exclusion criteria (17 listed)
- The patient must not be included if any of the criteria mentioned below are fulfilled:
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 | 1 |
| placebocalcium tablets once daily | Drug | 2 |
Primary outcome
Number of new and/or enlarging lesions on T2- weighted MRI based on MRI done 12 months following baseline compared with MRI done at baseline.
Time frame: one year
5 secondary outcomes
Changes in the EDSS score between baseline and 12 months after baseline.
Time frame: one year
Changes in the MFSC score between baseline and 12 months after baseline.
Time frame: one year
Number of documented relapses after baseline.
Time frame: one year
Changes in immunological parameters
Time frame: one year
Regulation of immunological activation.
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
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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, DMSC principal investigator
Department of Neurology, Glostrup Hospital, Denmark
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 Anna Tsakiri 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 8 inclusion and 17 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: withdrawn, as of the sponsor's last update on 20 Feb 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of new and/or enlarging lesions on T2- weighted MRI based on MRI done 12 months following baseline compared with MRI done at baseline. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2014.