| February 15, 2008 |
| April 30, 2009 |
| December 2007 |
| June 2010 (final data collection date for primary outcome measure) |
| Cumulative number of new T2-hyperintensive lesions on cranial magnetic resonance imaging (MRI) [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Cumulative number of new T2-hyperintensive lesions on cranial MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00623415 on ClinicalTrials.gov Archive Site |
- Cerebral atrophy (brain parenchymal fraction) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of new and total gadolinium(Gd)-enhancing lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC)) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|
- Cerebral atrophy (brain parenchymal fraction) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of new and total Gd-enhancing lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Disease progression (measured by EDSS, MSFC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|
| |
| Flupirtine as Oral Treatment in Multiple Sclerosis |
| Monocentric, 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, and clinical examination. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Relapsing Remitting Multiple Sclerosis |
- Drug: Flupirtine
- Drug: Placebo
|
- Active Comparator: flupirtine + interferon beta 1b
- Placebo Comparator: placebo + interferon beta 1b
|
| |
| |
| Recruiting |
| 80 |
| June 2011 |
| June 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 60 Years |
| No |
|
|
| Germany |
| |
| NCT00623415 |
| Charite University, Berlin, Germany, Charite University, Berlin, Germany |
| 2006-005262-39 |
| Charite University, Berlin, Germany |
| Bayer |
| Principal Investigator: |
Frauke Zipp, MD |
Cecilie Vogt Clinic for Neurology in the HKBB, Charité Berlin, Germany |
|
|
| Charite University, Berlin, Germany |
| April 2009 |
