Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SocraMetrics GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMP001 | Experimental | 600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMP001 | Drug | 600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at week -4, week 0 (baseline), week 4, 8, 12, 16, 20 and 24 |
| Comparison of T2- hyperintense lesions as assessed in MRI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria regarding the study medication:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulf Ziemann, MD | University Department of Neurology Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKT, Universitätsklinikum Tübingen | Tübingen | Baden-Würtemberg | 72076 | Germany | ||
| Goethe-Universität Frankfurt am Main |
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C505522 | tarenflurbil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 | at week 0 (baseline) and week 24 |
| relapse rate | Documentation of any replapse during study period to determine the annualised relapse rate | week -4 until week 24 |
| Expanded disability status scale (EDSS) | EDSS at weeks 12 and 24 as compared to baseline | at week 0 (baseline), week 12 and 24 |
| 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 | at week 0 (baseline), week 12 and 24 |
| TMP001-concentrations | Assessment of TMP001-concentrations | week 4, 8, 12, 16, 20 and 24 |
| Pain questionnaire | Pain questionnaire at BL, week 12 and week 24 | at week 0 (baseline), week 12 and week 24 |
| Frankfurt am Main |
| Hesse |
| 60528 |
| Germany |
| Universitätsklinikum Münster, Klinik für Allgemeine Neurologie | Münster | North Rhine-Westphalia | 48149 | Germany |
| Charite- Universitätsmedizin Berlin (Campus Mitte) NeuroCure Clinical Research Center NCRC AG Klinische Neuroimmunologie | Berlin | 10177 | Germany |
| Universitätsklinikum Heidelberg Neurologische Klinik | Heidelberg | 69120 | Germany |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |