Flupirtine as Oral Treatment in Multiple Sclerosis

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Bayer
• Treatments: Flupirtine; Interferon beta-1b; Interferons

Criteria

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