Clinical studies in neuroimmunological diseases
In cooperation with the Department of Neuroradiology, the Department of Neurology and Polyclinic offers participation in multicentre, national and international therapy studies for multiple sclerosis, neuromyelitis optica spectrum disorders (NMOSD), MOG antibody associated disorder (MOGAD) and other immune-mediated diseases. These therapy studies are investigating the benefits of new drugs that inhibit disease-related inflammatory activity by attacking various components of the immune system. These studies are coordinated by our department and pharmaceutical companies or national networks on rare diseases. You are welcome to contact us for details of the respective therapy studies.
Clinical trials are currently being offered for the following indications:
| Focus on | Neuroimmunology |
| Indication | Multiple sclerosis |
| Short title | CLAProMs |
| Study title | Effects of a combined supplementation of conjugated linoleic acid (CLA) and probiotics (Vivomixx®/VSL#3) as add-on to a first-line immunotherapy in relapsing-remitting multiple sclerosis |
| Brief description | Effects of a combined dietary supplement with conjugated linoleic acid (CLA) and probiotics (Vivomixx®/VSL#3) as add-on to a first-line therapy in patients with relapsing-remitting multiple sclerosis |
| Phase | IIT |
| ClinicalTrials.gov Identifier | NCT05920018 |
| Status | Recruitment ongoing |
| Contact | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |
| Focus on | Neuroimmunology |
| Indication | Multiple sclerosis |
| Short title | STHENOS |
| Study title | COMB157G3301 |
| Brief description | An open-label, evaluator-blinded, randomised, multicentre, parallel arm study with active comparator therapies to assess the efficacy and tolerability of monthly subcutaneous ofatumumab 20 mg versus first-line course-modifying therapies of the physician's choice for the treatment of newly diagnosed relapsing-remitting multiple sclerosis (STHENOS) |
| Phase | IIIb |
| EudraCT-Number | 2020-004505-32 |
| Status | Follow up |
| Contact Prof. | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |
| Focus on | Neuroimmunology |
| Indication | Multiple sclerosis |
| Short title | RECLAIM |
| Study title | German registry project for autologous haematopoietic stem cell transplantation (AHSZT) in multiple sclerosis/German REgistry Cohort of autoLogous hematopoietic stem cell trAnsplantation in MS |
| Brief description | The project is carried out by the Task Force Autologous Stem Cell Transplantation in Multiple Sclerosis (MS) in the Clinical Competence Network MS (KKNMS) (spokespersons: Christoph Heesen, Hamburg; Brigitte Wildemann, Heidelberg). Systematic recording of the efficacy and side effect profile of AHSZT in the indication MS, among other things to assess the benefit of this treatment procedure, which has rarely been carried out to date, in highly active relapsing as well as chronic courses and to accelerate the assumption of costs by the health insurance companies in suitable patients. |
| Phase | Retrospective register study |
| EudraCT-Number | not available |
| Status | Recruitment ongoing |
| Contact Prof. Dr. Brigitte Wildemann | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |
| Focus on | Neuroimmunology |
| Indication | Multiple sclerosis |
| Short title | CONFIDENCE |
| Study title | Safety and effectiveness of Ocrelizumab under real world conditions |
| Short description | Long-term study on the safety and efficacy of ocrelizumab in patients with relapsing or early primary progressive multiple sclerosis in clinical practice. |
| Phase | NIS |
| EudraCT-Number | Not available |
| Status | Follow Up |
| Contact | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |
| Focus on | Neuroimmunology |
| Indication | Multiple sclerosis |
| Short title | ALITHIOS COMB157G2399 |
| Study title | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy |
| Brief description | An open-label, single-arm, multicentre extension study to evaluate the long-term safety, tolerability and efficacy of ofatumumab in patients with relapsing multiple sclerosis |
| Phase | IIIb |
| EudraCT-Number | 2017-004703-51 |
| Status | Follow up |
| Contact Prof. | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |
| Focus on | Neuroimmunology |
| Indication | CIS, relapsing-remitting multiple sclerosis without prior therapy |
| Short title | Nation MS |
| Study title | Cohort study KKNMS |
| Brief description | Prospective cohort study in patients with CIS (clinically isolated syndrome) and early multiple sclerosis. Follow-up before initiation of immunomodulatory therapy in MS & CIS using clinical data / biobank |
| phase | Registry study |
| EudraCT-Number | Not available |
| Status | Follow up |
| Contact | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |
| Focus on | Neuroimmunology |
| Indication | Optic neuritis, NMOSD and MOGAD |
| Short title | NEMOS |
| Study title | NEMOS/Nation NMO Cohort Study |
| Brief description | Diagnostics, therapy and course of NMOSD and MOGAD: a non-interventional cohort study of the Neuromyelitis optica Study Group |
| Study status | Registry study |
| EudraCT-Number | not available |
| Contact | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |
| Focus on | Neuroimmunology |
| Indication | Autoimmune encephalitis and cerebellitis |
| Short title | GENERATE |
| Study title | Database and biomaterial collection of the German Network for Research on Autoimmune Encephalitis (GENERATE) |
| Brief description | The aim of GENERATE is to collect register data and biomaterials from patients with autoimmune encephalitis. This data will be used to clarify the symptoms, risk and prognosis factors as well as the care situation in Germany. Recruitment of patients for controlled therapy studies and work with biomaterials will be facilitated and simplified. |
| Phase | Register study |
| EudraCT-Number | Not available |
| Status | Recruitment ongoing |
| Contact | Prof Dr Brigitte Wildemann 06221-567504 brigitte.wildemann@med.uni-heidelberg.de |