Clinical trial NCT00623415: Flupirtine as Oral Treatment in Multiple Sclerosis
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
timeFrame: 12 months
Secondary outcomes:
measure: Cerebral atrophy (brain parenchymal fraction)
timeFrame: 12 months
measure: Number of new and total gadolinium(Gd)-enhancing lesions
timeFrame: 12 months
measure: Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))
timeFrame: 12 months
measure: Retinal nerve fiber layer thickness, assessed by Optical coherence tomography
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: NeuroCure Clinical Research Center, Charité Berlin
city: Cottbus
country: Germany
facility: Carl-Thiem-Clinic Cottbus
city: Göttingen
country: Germany
facility: University of Göttingen, Department of Neurology
city: Ulm
country: Germany
facility: University of Ulm, Department of Neurology
Study officials:
affiliation: NeuroCure Clinical Research Center, Charité Berlin, Germany
name: Friedemann Paul, MD
role: PRINCIPAL_INVESTIGATOR
References: