Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)

Charité University Medicine Berlin

Status and phase

Terminated

Phase 2

Conditions

Relapsing Remitting Multiple Sclerosis

Treatments

Drug: Placebo

Drug: Flupirtine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00623415

2006-005262-39

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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