Flupirtine as Oral Treatment in Multiple Sclerosis

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

Stopped earlyPhase 2Relapsing MSNCT006234152006-005262-39

What it found

Stopped

The trial ended early for another reason (see below).

development of new lesions on cranial MRI · 12 months

Total participants: 30

Read by software from the paper's abstract

This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Flupirtine
  • Flupirtin

Placebo

  • Placebo

What it measured

Main measures

  • Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)

    12 months

    MRI lesions

  • Primary objectives are the incidence of new T2-lesions, the number of patients without newly occurring T2 lesions over the treatmant period, "lesion load", number and volume of "black holes", "brain parenchymal fraction" measured by cerebral MRI and changes in the relation of NAA and choline measured by MRS.

    MRI lesionsBrain volume loss

Other measures (4)

  • Cerebral atrophy (brain parenchymal fraction)

    12 months

    Brain volume loss

  • Number of new and total gadolinium(Gd)-enhancing lesions

    12 months

    MRI lesions

  • Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))

    12 months

    Disability progression

  • Retinal nerve fiber layer thickness, assessed by Optical coherence tomography

    12 months

    Retina scans (OCT)

Who could take part

Relapsing MS · 18 to 60

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Dec 2007

      2. Main results due

        Nov 2012

      3. Finished

        Nov 2012

      Assembled by software from public sources.