The purpose of this study is to assess the impact of TMP001 in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Therefore the average total number of contrast enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 during treatment with TMP001 is compared to the average total number of CELs on brain MRI scans at week -4 and baseline in these patients . Based on promising preclinical results, the investigators assume a comparable effect of TMP001 on reduction of contrast-enhancing lesions as shown for other immunomodulatory substances in recent clinical studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks
UKT, Universitätsklinikum Tübingen
Tübingen, Baden-Würtemberg, Germany
Goethe-Universität Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Münster, Klinik für Allgemeine Neurologie
Münster, North Rhine-Westphalia, Germany
Charite- Universitätsmedizin Berlin (Campus Mitte) NeuroCure Clinical Research Center NCRC AG Klinische Neuroimmunologie
Berlin, Germany
Comparison of average total number of contrast enhancing lesions
Comparison of average total number of contrast enhancing lesions (CELs) on Brain MRI scans at weeks 4, 8, 12, 16, 20 and 24 as compared to the average total number of CELs on brain MRI scans at week -4 and baseline (BL)
Time frame: at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24
Comparison of average total volume of contrast enhancing lesions
Average total volume of CELs (in mm3) on brain MRI scans at week 4,8, 12, 16, 20 and 24 as compared to the average total CEL volume on brain MRI scans at week -4 and BL
Time frame: at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24
Comparison of T2- hyperintense lesions as assessed in MRI
New or enlarged T2- hyperintense lesions at week 24 as compared to baseline - Number and Characteristics of T2-hyperintense leasion as to be found in MRI Assessment in Comparison between baseline and week 24
Time frame: at week 0 (baseline) and week 24
Comparison of T1-hypointense lesions as assessed in MRI
New T1-hypointense lesions at week 24 as compared to baseline as to be found in MRI Assessment in Comparison between baseline and week 24
Time frame: at week 0 (baseline) and week 24
relapse rate
Documentation of any replapse during study period to determine the annualised relapse rate
Time frame: week -4 until week 24
Expanded disability status scale (EDSS)
EDSS at weeks 12 and 24 as compared to baseline
Time frame: at week 0 (baseline), week 12 and 24
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Universitätsklinikum Heidelberg Neurologische Klinik
Heidelberg, Germany
Assessment of Lipid profile at different time points
Concentration of a variety of lipids will be determined at weeks 12 and 24 and described in comparison to the lipid profile at baseline
Time frame: at week 0 (baseline), week 12 and 24
TMP001-concentrations
Assessment of TMP001-concentrations
Time frame: week 4, 8, 12, 16, 20 and 24
Pain questionnaire
Pain questionnaire at BL, week 12 and week 24
Time frame: at week 0 (baseline), week 12 and week 24