Flupirtine as Oral Treatment in Multiple Sclerosis - Full Text View

Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Charite University, Berlin, Germany. Recruitment status was Recruiting

First Received on February 15, 2008. Last Updated on August 9, 2010 History of Changes

Sponsor:	Charite University, Berlin, Germany
Collaborator:	Bayer
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00623415

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 II

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:

MedlinePlus related topics: MRI Scans Multiple Sclerosis

Drug Information available for: Flupirtine Interferons

U.S. FDA Resources

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 ]

Estimated Enrollment:	80
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623415

Contacts

Contact: Friedemann Paul, MD	+49 30 450 ext 539040	friedemann.paul@charite.de
Contact: Jan Doerr, MD	+49 30 450 ext 539040	jan-markus.doerr@charite.de

Locations

Germany
NeuroCure Clinical Research Center, Charité Berlin	Recruiting
Berlin, Germany, 10117
Contact: Jan Doerr, MD +49 30 450 ext 539040 jan-markus.doerr@charite.de
University of Göttingen, Department of Neurology	Recruiting
Göttingen, Germany, 37075
Contact: Mikael Simons, MD msimons@gwdg.de
Principal Investigator: Mikael Simons, Prof.
University of Ulm, Department of Neurology	Recruiting
Ulm, Germany
Contact: Hayrettin Ulm, Prof.
Principal Investigator: Hayrettin Tumani, Prof.

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:	August 9, 2010
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 February 09, 2012