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TERMINATEDPhase 2NCT00623415

Flupirtine as Oral Treatment in Multiple Sclerosis

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 scle...

Lead sponsor: Charite University, Berlin, Germany•4 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Charite University, Berlin, Germany

Collaborators

Bayer

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 20, 2018Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment30

Start dateDec 2007

Last updatedMar 20, 2018

Condition

Relapsing Remitting Multiple Sclerosis

Locations shown

NeuroCure Clinical Research Center, Charité Berlin

Berlin

Carl-Thiem-Clinic Cottbus

Cottbus

University of Göttingen, Department of Neurology

Göttingen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2018Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions