E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-remitting multiple sclerosis |
|
MedDRA Classification |
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 |
Assessment of efficacy and safety of flupirtin compared to placebo as an add-on to treatment with IFN-beta in RR-MS. Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are the annualized number of relapses over 12 months of flupirtin treatment compared to 12 months prior to treatment, the number of patients without relapse, progression of disability, parameters of neuronal atrophy, cognitive/ neuropsychological parameters and the effects of flupirtin on peripheral mononuclear blood cells compared to placebo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
written informed consent, age 18-55 yrs. at randomization, RR-MS according to revised McDonald criteria (2005), EDSS</=4,0, stable IFN-beta therapy for > 6 months, in women reliable contraception (Pearl index <1), negative pregnancy test at inclusion |
|
E.4 | Principal exclusion criteria |
all other forms of MS apart from RR-MS, any other illness that could explain symptoms better than RR-MS, any condition preventing/ disturbing cMRI or other examinations, relevant gastrointestinal, pulmonary, infectious, heart or CNS disease, relevant liver disease, cholestasis, elevated liver enzymes and bilirubin, bone marrow dysfunction, renal dysfunction, myasthenia gravis, allergy against gadolinium-DTPA, flupirtin maleat or additives, treatment with drugs toxic to liver, anticoagulants, carbamazepine or paracetamol, alcohol or drug abuse, pregnancy, lactation |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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.8.5 | 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 | Yes |
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
|
End of the trial will be when the last of 80 participants has had his/her last study visit according to the protocol. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |