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Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623415
First Posted: February 26, 2008
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Drug: Flupirtine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI) [ Time Frame: 12 months ]

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

Enrollment: 30
Study Start Date: December 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Verum
flupirtine + interferon beta 1b
Drug: Flupirtine
300 mg daily (divided in two doses)
Placebo Comparator: Placebo
placebo + interferon beta 1b
Drug: Placebo
twice daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623415


Locations
Germany
NeuroCure Clinical Research Center, Charité Berlin
Berlin, Germany, 10117
Carl-Thiem-Clinic Cottbus
Cottbus, Germany, 03048
University of Göttingen, Department of Neurology
Göttingen, Germany, 37075
University of Ulm, Department of Neurology
Ulm, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Bayer
Investigators
Principal Investigator: Friedemann Paul, MD NeuroCure Clinical Research Center, Charité Berlin, Germany
  More Information

Responsible Party: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00623415     History of Changes
Other Study ID Numbers: 2006-005262-39
First Submitted: February 15, 2008
First Posted: February 26, 2008
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon beta-1b
Flupirtine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents


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