Flupirtine as Oral Treatment in Multiple Sclerosis (FLORIMS)

March 19, 2018 updated by: Charite University, Berlin, Germany

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • NeuroCure Clinical Research Center, Charité Berlin
      • Cottbus, Germany, 03048
        • Carl-Thiem-Clinic Cottbus
      • Göttingen, Germany, 37075
        • University of Göttingen, Department of Neurology
      • Ulm, Germany
        • University of Ulm, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Bayer

Investigators

  • Principal Investigator: Friedemann Paul, MD, NeuroCure Clinical Research Center, Charité Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (ESTIMATE)

February 26, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-005262-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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