Flupirtine as Oral Treatment in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Flupirtine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verum<br>flupirtine + interferon beta 1b | Drug: Flupirtine<br>* 300 mg daily (divided in two doses)<br>|
| Placebo Comparator: Placebo<br>placebo + interferon beta 1b | Drug: Placebo<br>* twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral atrophy (brain parenchymal fraction) |  | 12 months | 
| Number of new and total gadolinium(Gd)-enhancing lesions |  | 12 months | 
| Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC)) |  | 12 months | 
| Retinal nerve fiber layer thickness, assessed by Optical coherence tomography |  | 12 months |