Flupirtine as Oral Treatment in Multiple Sclerosis

Phase 2

Terminated

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: Flupirtine

• Registration Number: NCT00623415
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-26
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2017-12
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo + interferon beta 1b
Verum	Flupirtine	flupirtine + interferon beta 1b

Primary Outcome Measures

Name	Time	Method
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)	12 months

Secondary Outcome Measures

Name	Time	Method
Number of new and total gadolinium(Gd)-enhancing lesions	12 months
Cerebral atrophy (brain parenchymal fraction)	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

Trial Locations

Locations (4)

NeuroCure Clinical Research Center, Charité Berlin; 🇩🇪 Berlin, Germany

Carl-Thiem-Clinic Cottbus; 🇩🇪 Cottbus, Germany

University of Ulm, Department of Neurology; 🇩🇪 Ulm, Germany

University of Göttingen, Department of Neurology; 🇩🇪 Göttingen, Germany