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Trial record 1 of 1 for:    florims
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Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)

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. Identifier: NCT00623415
Recruitment Status : Terminated
First Posted : February 26, 2008
Last Update Posted : March 20, 2018
Information provided by:
Charite University, Berlin, Germany

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 sclerosis over a period of 12 months. Neuroprotection is assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence tomography, and clinical examination.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Flupirtine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : December 2007
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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

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

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 identifier (NCT number): NCT00623415

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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
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Principal Investigator: Friedemann Paul, MD NeuroCure Clinical Research Center, Charité Berlin, Germany
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Responsible Party: Charite University, Berlin, Germany Identifier: NCT00623415    
Other Study ID Numbers: 2006-005262-39
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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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
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs