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

NCT00429442 | Withdrawn Phase 3

• 2 other identifiers: CoSim-01EudraCT number 2006-001827-21
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Simvastatin; CNS Inflammation; Copaxone

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (5)

• Changes in the EDSS score between baseline and 12 months after baseline.

  one year

• Changes in the MFSC score between baseline and 12 months after baseline.

  one year

• Number of documented relapses after baseline.

  one year

• Changes in immunological parameters

  one year

• Regulation of immunological activation.

  one year

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Simvastatin

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Simvastatin DRUG

80 mg once daily

1

placebo DRUG

calcium tablets once daily

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Anna Tsakiri: lead
• Sanofi: collaborator

Study Sites (1)

Department of Neurology, Glostrup University Hospital

Glostrup Municipality, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jette L Frederiksen, DMSC

  Department of Neurology, Glostrup Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: January 31, 2007
• Study Start: March 1, 2008
• Study Completion: March 1, 2011
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

DK (1)