Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)

This study has been terminated.
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
First received: February 15, 2008
Last updated: January 27, 2016
Last verified: January 2016
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebral atrophy (brain parenchymal fraction) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of new and total gadolinium(Gd)-enhancing lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC)) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Retinal nerve fiber layer thickness, assessed by Optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00623415

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
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 
Study First Received: February 15, 2008
Last Updated: January 27, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 25, 2016