Flupirtine as Oral Treatment in Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00623415
• Other study ID #: 2006-005262-39
• Status: Terminated
• Phase: Phase 2
• First received: February 15, 2008
• Last updated: March 19, 2018
• Start date: December 2007
• Est. completion date: November 2012

Study information

• Verified date: December 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Relapsing-remitting MS according to the revised McDonald-Criteria (2005)

• EDSS = 4.0

• Stable treatment with Interferon-ß1b 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-ß1b or intravenous methylprednisolone

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Flupirtine
300 mg daily (divided in two doses)
• Placebo
twice daily

Locations

Country	Name	City	State
Germany	NeuroCure Clinical Research Center, Charité Berlin	Berlin
Germany	Carl-Thiem-Clinic Cottbus	Cottbus
Germany	University of Göttingen, Department of Neurology	Göttingen
Germany	University of Ulm, Department of Neurology	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)		12 months
Secondary	Cerebral atrophy (brain parenchymal fraction)		12 months
Secondary	Number of new and total gadolinium(Gd)-enhancing lesions		12 months
Secondary	Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))		12 months
Secondary	Retinal nerve fiber layer thickness, assessed by Optical coherence tomography		12 months