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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00623415

Acronym

FLORIMS

Enrollment

Registered

2008-02-26

Start date

2007-12-31

Completion date

2012-11-30

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis

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.

Interventions

DRUGFlupirtine

300 mg daily (divided in two doses)

DRUGPlacebo

twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026