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Status:

TERMINATED

Flupirtine as Oral Treatment in Multiple Sclerosis

Lead Sponsor:

Charite University, Berlin, Germany

Collaborating Sponsors:

Bayer

Conditions:

Relapsing Remitting Multiple Sclerosis

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

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 scle...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2012

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00623415

Start Date

December 1 2007

End Date

November 1 2012

Last Update

March 20 2018

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

NeuroCure Clinical Research Center, Charité Berlin

Berlin, Germany, 10117

2

Carl-Thiem-Clinic Cottbus

Cottbus, Germany, 03048

3

University of Göttingen, Department of Neurology

Göttingen, Germany, 37075

4

University of Ulm, Department of Neurology

Ulm, Germany