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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
300 mg daily (divided in two doses)
twice daily
NeuroCure Clinical Research Center, Charité Berlin
Berlin, Germany
Carl-Thiem-Clinic Cottbus
Cottbus, Germany
University of Göttingen, Department of Neurology
Göttingen, Germany
University of Ulm, Department of Neurology
Ulm, Germany
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
Time frame: 12 months
Cerebral atrophy (brain parenchymal fraction)
Time frame: 12 months
Number of new and total gadolinium(Gd)-enhancing lesions
Time frame: 12 months
Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))
Time frame: 12 months
Retinal nerve fiber layer thickness, assessed by Optical coherence tomography
Time frame: 12 months
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