Flupirtin as Oral Treatment in MS

INTERVENTION: Trade Name: Trancopal Dolo Product Name: Flupirtin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Flupirtin CAS Number: 56995‐20‐1 Other descriptive name: Flupirtinmaleat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Relapsing‐remitting multiple sclerosis PRIMARY OUTCOME: Main Objective: 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. 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. Secondary Objective: 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. INCLUSION CRITERIA: written informed consent, age 18‐55 yrs. at randomization, RR‐MS according to revised McDonald criteria (2005), EDSS 6 months, in women reliable contraception (Pearl index <1), negative pregnancy test at inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range