Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)

This study has been terminated.
Sponsor:
Collaborator:
Bayer
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00623415
First received: February 15, 2008
Last updated: February 10, 2014
Last verified: January 2014
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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: February 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferons
Flupirtine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014