Flupirtine as Oral Treatment in Multiple Sclerosis

Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-β1b on Neurodegeneration in Patients With Relapsing Remitting Multiple Sclerosis

Flupirtine, a non-opioid analgesic drug, that has been shown to have additional neuroprotective functions, is given twice daily as an oral medication in patients with relapsing remitting multiple sclerosis over a period of 12 months. Neuroprotection is assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence tomography, and clinical examination.

Inclusion Criteria:

• Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
• EDSS ≤ 4.0
• Stable treatment with Interferon-β1b for at least 6 months
• Sufficient birth control (Pearl-Index <1)

Exclusion Criteria:

• Any other MS-course than RRMS
• Clinically relevant gastrointestinal disease
• Clinically relevant pulmonary, cardiological, infectious or CNS-disease
• Clinically relevant disease of liver or bile system, pathological value for transaminases, gamma-GT or bilirubin.
• Hepatitis (except uncomplicated hepatitis A with complete remission
• Clinically relevant dysfunction of kidneys (creatinine >180 µmol/l) or bone marrow (HB < 8.5 g/dl, WBC < 2.5/nl thrombocytes < 125/nl)
• Myasthenia gravis
• Oral anticoagulation (phenprocoumon)
• Treatment with carbamazepine or paracetamol
• Drug or alcohol abuse
• Pregnancy or lactation period
• Treatment at any time before or during study with complete lymphoradiation, monoclonal antibodies (e.g. anti-CD4, Campath 1H, natalizumab), mitoxantrone, cyclophosphamide, cyclosporin, azathioprine
• Treatment within 6 months before randomization with any other immunomodulatory substance than interferon-β1b or intravenous methylprednisolone