E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to estimate the effect of Copaxone with an add-on of simvastatin versus Copaxone with an add-on of placebo on: 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.
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E.2.2 | Secondary objectives of the trial |
to estimate the effect of Copaxone with an add-on of simvastatin versus Copaxone with an add-on of placebo on: Changes in the EDSS score between baseline and 12 months after baseline. Number of documented relapses after baseline. Changes in immunological parameters Regulation of immunological activation.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 65 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 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to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
To estimate the effect of Glatiramer acetate with an add-on of simvastatin versus Glatiramer acetate with an add-on of placebo on: Number of new and/or enlarging lesions on T2-weighted MRI based on MRI done at 12 months compared with MRI done at baseline.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |