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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Anna Tsakiri, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:
NCT00429442
First received: January 30, 2007
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Simvastatin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: March 2008
Estimated Study Completion Date: March 2011
Arms Assigned Interventions
Active Comparator: 1 Drug: Simvastatin
80 mg once daily
Placebo Comparator: 2 Drug: placebo
calcium tablets once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429442

Locations
Denmark
Department of Neurology, Glostrup University Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Anna Tsakiri
Sanofi
Investigators
Principal Investigator: Jette L Frederiksen, DMSC Department of Neurology, Glostrup Hospital, Denmark
  More Information

No publications provided

Responsible Party: Anna Tsakiri, MD, PhD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier: NCT00429442     History of Changes
Other Study ID Numbers: CoSim-01, EudraCT number 2006-001827-21
Study First Received: January 30, 2007
Last Updated: February 19, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Simvastatin
CNS Inflammation
Copaxone

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Simvastatin
Copolymer 1
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 21, 2014