Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2007-12-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Verum
flupirtine + interferon beta 1b
Flupirtine
300 mg daily (divided in two doses)
Placebo
placebo + interferon beta 1b
Placebo
twice daily
Interventions
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Flupirtine
300 mg daily (divided in two doses)
Placebo
twice daily
Eligibility Criteria
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Inclusion Criteria
* EDSS ≤ 4.0
* Stable treatment with Interferon-β1b for at least 6 months
* Sufficient birth control (Pearl-Index \<1)
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Charite University, Berlin, Germany
OTHER
Responsible Party
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Charite University, Berlin, Germany
Principal Investigators
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Friedemann Paul, MD
Role: PRINCIPAL_INVESTIGATOR
NeuroCure Clinical Research Center, Charité Berlin, Germany
Locations
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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
Countries
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Other Identifiers
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2006-005262-39
Identifier Type: -
Identifier Source: org_study_id
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