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 | HLT |
E.1.2 | Classification code | 10052785 |
E.1.2 | Term | Multiple sclerosis acute and progressive |
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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 |
 To evaluate the effect of combination therapy IFN beta 1a 44 mcg t.i.w. + 1200 mg N-Acetyl Cysteine vs IFN beta 1a 44 mcg t.i.w. + placebo on neurodegeneration as assessed by MRI spectroscopy during 24 months of treatment in subject with RR MS |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of combination therapy on other MRI parameters of neurodegeneration To assess the effect of combination therapy in reducing lesions activity compared to monotherapy as assessed by MRI To assess the safety of combination therapy To assess the effect of combination therapy on clinical parameters |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must be between the ages of 18 and 50 years inclusive. 2. Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive or double-barrier method (condom or IUD with spermicide). 3. Clinically Definite Multiple Sclerosis (CDMS) as defined by Mc Donald criteria 4. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive. 5. Subjects must have a relapsing-remitting disease course 6. Subjects must have started therapy with IFN-beta-1a 44mcg s.c. t.i.w. within three months prior to the screening visit 7. Subjects must be relapse-free within the 30 days prior to the screening visit. 8. Subjects must not have taken corticosteroids (IV, IM and/or PO) within the 30 days, immunomodulators within the 60 days, immunosuppressors within 6 months prior to the screening visit |
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E.4 | Principal exclusion criteria |
1. Use of experimental or investigational drugs, including I.V. immunoglobulin, within 6 months prior to study entry. 2. Chronic use of antioxidant substance(s), including NAC, (more than 30 consecutive days) within 60 days prior to the screening visit. 3. Previous total body irradiation or total lymphoid irradiation (TLI) 4. Pregnancy or breastfeeding. 5. Significant medical or psychiatric condition that affects the subjects ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse). 6. A known history of uncontrolled asthma. 7. A known history of sensitivity to acetylcysteine. 8. Inability to successfully undergo MRI scanning. 9. Primary or secondary epilepsy 10. Hystory of brain trauma with sequelae |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
E.6.4 | Safety | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |