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Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00429442
Recruitment Status : Withdrawn
First Posted : January 31, 2007
Last Update Posted : February 20, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Anna Tsakiri, Glostrup University Hospital, Copenhagen

Tracking Information
First Submitted Date  ICMJE January 30, 2007
First Posted Date  ICMJE January 31, 2007
Last Update Posted Date February 20, 2014
Study Start Date  ICMJE March 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2007)
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.
Change History Complete list of historical versions of study NCT00429442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2007)
  • Changes in the EDSS score between baseline and 12 months after baseline.
  • Changes in the MFSC score between baseline and 12 months after baseline.
  • Number of documented relapses after baseline.
  • Changes in immunological parameters
  • Regulation of immunological activation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis
Official Title  ICMJE 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
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Remitting Multiple Sclerosis
Intervention  ICMJE
  • Drug: Simvastatin
    80 mg once daily
  • Drug: placebo
    calcium tablets once daily
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Simvastatin
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 19, 2014)
0
Original Enrollment  ICMJE
 (submitted: January 30, 2007)
20
Estimated Study Completion Date  ICMJE March 2011
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00429442
Other Study ID Numbers  ICMJE CoSim-01
EudraCT number 2006-001827-21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Tsakiri, Glostrup University Hospital, Copenhagen
Study Sponsor  ICMJE Anna Tsakiri
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Jette L Frederiksen, DMSC Department of Neurology, Glostrup Hospital, Denmark
PRS Account Glostrup University Hospital, Copenhagen
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP