Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Flupirtine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis
Eligibility 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
Sites / Locations
- NeuroCure Clinical Research Center, Charité Berlin
- Carl-Thiem-Clinic Cottbus
- University of Göttingen, Department of Neurology
- University of Ulm, Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Verum
Placebo
Arm Description
flupirtine + interferon beta 1b
placebo + interferon beta 1b
Outcomes
Primary Outcome Measures
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
Secondary Outcome Measures
Cerebral atrophy (brain parenchymal fraction)
Number of new and total gadolinium(Gd)-enhancing lesions
Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))
Retinal nerve fiber layer thickness, assessed by Optical coherence tomography
Full Information
NCT ID
NCT00623415
First Posted
February 15, 2008
Last Updated
March 19, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00623415
Brief Title
Flupirtine as Oral Treatment in Multiple Sclerosis
Acronym
FLORIMS
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 Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verum
Arm Type
Active Comparator
Arm Description
flupirtine + interferon beta 1b
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo + interferon beta 1b
Intervention Type
Drug
Intervention Name(s)
Flupirtine
Intervention Description
300 mg daily (divided in two doses)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
twice daily
Primary Outcome Measure Information:
Title
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cerebral atrophy (brain parenchymal fraction)
Time Frame
12 months
Title
Number of new and total gadolinium(Gd)-enhancing lesions
Time Frame
12 months
Title
Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))
Time Frame
12 months
Title
Retinal nerve fiber layer thickness, assessed by Optical coherence tomography
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, MD
Organizational Affiliation
NeuroCure Clinical Research Center, Charité Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroCure Clinical Research Center, Charité Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Carl-Thiem-Clinic Cottbus
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
University of Göttingen, Department of Neurology
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
University of Ulm, Department of Neurology
City
Ulm
Country
Germany
12. IPD Sharing Statement
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Flupirtine as Oral Treatment in Multiple Sclerosis
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