Welcome to the website of the clinical study centre
Centre for Clinical Research at the Department of Neurology
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About us
The Clinical Trial Centre provides the facilities and personnel infrastructure for conducting clinical trials, with a focus on amyothrophic lateral sclerosis (ALS) and motor system disorders, dementia / Alzheimer's, epilepsy, Huntington's disease, multiple sclerosis and inflammatory CNS disorders, Parkinson's syndromes and movement disorders and stroke disorders.
Our aim is to be involved in trialling and testing the latest forms of therapy. Testing as part of a clinical trial offers controlled conditions and close contact with the trial patients to ensure the greatest possible patient safety.
Special attention is paid to the national and international networking of the study centre. The following networks were initiated from Ulm: the German Network for Motor Neurone Diseases (MND-NET), the Register for the Epidemiology of ALS in Swabia, the Dementia Competence Network - FTLD, the European Huntington's Disease Network and the collaboration with the Peking University Health Science Centre. We are also involved in projects of the Competence Network Multiple Sclerosis (KKNMS) and the German Parkinson Study Group (GPS).
Leitung des klinischen Studienzentrums
Clinical studies
Contact person:
Mrs Elke Fröhlich
Phone: 0731 / 177 5362
Email: elke.froehlich@uni-ulm.de
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Current studies
LIPCAL-ALS II
Therapy substance:
Intervention group: ultra-high-calorie high-fat dietary supplement, 4x 35 ml/day (100% lipids, +630 kcal/day)
Control group: Placebo, 4x 35 ml/day
Study objective:
In the previous study (LIPCAL I), it was shown that a high-calorie, high-fat dietary supplement (+405 kcal/day) leads to improved survival in patients with rapidly progressive ALS. In this study, the effect of an ultra-high-calorie, high-fat dietary supplement (+630 kcal/day) on survival is now being explored.
Duration of treatment:
Within 18 months, 5 visits to the study centre and 5 telephone visits are planned.
Recruitment status:
Inclusion in the study possible at any time
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KETO-ALS
Study title: Efficacy and tolerability of beta-hydroxybutyrate ester for patients with amyotrophic lateral sclerosis (ALS)
Therapeutic substance: Group A: Beta-hydroxybutyrate, 3 x 20 ml KetoForce®/day
Group B: Placebo, 3 x 20 ml/day
Beta-hydroxybutyrate/placebo in a ratio of 1:1
Aim of the study: Other studies have shown that weight stabilisation has a positive effect on the course of the disease and is associated with a significantly longer survival time. In this study, the effect of ketone bodies on the course of the disease is to be tested. It will also investigate whether beta-hydroxybutyrate lowers the neurofilament light chain (NfL) serum level as a negative prognostic biomarker in ALS.
Duration of treatment: 3 appointments at the study centre and 2 telephone visits are planned within 6 months.
Recruitment status: Inclusion in the study possible at any time
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PTC857-CNS-001-ALS (Phase-2-Studie)
Study title: A phase 2, randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, PK and biomarker effects of PTC857 in adult patients with amyotrophic lateral sclerosis (CARDINALS)
Therapeutic substance: Group 1: PTC857, 250 mg 2x/day
Group 2: placebo 2x/day
Group 1/group 2 in a ratio of 2:1
Study objective: To investigate the safety and efficacy of PTC857 in patients with amyotrophic lateral sclerosis (ALS). PTC857 acts as an inhibitor of the oxidoreductase 15-lipoxygenase (15-LO) and is intended to reduce inflammatory reactions and oxidative stress and have a positive effect on the course of the disease.
Duration of treatment: In the 24-week double-blind phase, there will be 4 visits to the study centre and 5 telephone visits, as well as 3 visits and 3 telephone visits in the 28-week open extension phase.
Recruitment status: Recruitment completed
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CORT113176 (DAZALS) (Phase 2 study)
Study title: A multicentre, randomised, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of CORT113176 (Dazucorilant) in patients with amyotrophic lateral sclerosis (DAZALS)
Therapeutic substance: Group 1: CORT113176 150 mg 4 Kps. 1x/day orally
Group 2: CORT113176 300 mg 4 capsules 1x/day orally
Group 3: Placebo 4 capsules 1x/day orally
Group 1/group 2/group 3 in a ratio of 1:1:1
Study objective: To evaluate the efficacy and safety of CORT113176 in patients with amyotrophic lateral sclerosis (ALS). Cort113176 is a selective modulator of the glucocorticoid receptor (GR). Modulation of cortisol activity is intended to reduce inflammatory processes in the nervous system and thus have a positive effect on the course of the disease.
Treatment duration: 24-week double-blind phase with 6 centre visits and 3 telephone visits, as well as a maximum 132-week open treatment phase with centre and telephone visits.
Recruitment status: Recruitment completed
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Lilly AP101-02 (Phase 2a study)
Study title: A multicentre, randomised, double-blind, placebo-controlled Phase 2a study to investigate the safety, tolerability, pharmacodynamic markers and pharmacokinetics of AP-101 in patients with familial amyotrophic lateral sclerosis (fALS/SOD1 mutation) and sporadic amyotrophic lateral sclerosis (sALS)
Therapeutic substance: Group 1: AP 101-02, 2500 mg i.v.
Group 2: Placebo
Group 1/group 2 in a ratio of 2:1
Aim of the study: To investigatewhether treatment approaches targeting pathogenic versions of SOD1 (e.g. mutated, aggregated, oxidised or misfolded) have the potential to delay disease progression in patients with ALS.
Treatment duration: 10 appointments at the study centre within approx. 6 months (one infusion every 3 weeks, with the option of an open extension phase over 6 months), final 3-month follow-up phase with 3 visits.
Recruitment status: Inclusion in the study possible at any time
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Amylyx AMX0035 (Phase 3 study)
Study title: A randomised, placebo-controlled study to investigate the safety and efficacy of AMX0035 compared to placebo for a 48-week treatment of adult patients with ALS
Therapeutic agent: AMX0035 (taurursodiol and sodium phenylbutyrate) orally 2x/day
Control: placebo orally 2x/day
AMX0035/placebo in a ratio of 3:2
Aim of the study: To investigate whether a reduction in the degeneration of neurones leads to a slowdown in the progression of the disease, based on the ALS Functional Rating Scale (ALS-FRS).
Duration of treatment: 6 appointments at the study centre and several telephone visits are planned within 48 weeks.
Recruitment status: Recruitment completed
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Biogen 233AS101 (Phase 3 study); only ALS patients with SOD1 mutation
Study title: A study to evaluate the efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics of BIIB067 administered to patients with amyotrophic lateral sclerosis and confirmed SOD1 mutation, a randomised, double-blind, placebo-controlled phase 3 study with subsequent open-label extension phase
Therapeutic agent:
Antisense oligonucleotide (BIIB067); Part C 100 mg 8 x intrathecal injections
Control: Placebo 8 x intrathecal injections
Ratio BIIBO67/placebo 2:1
Study objective: To investigate the tolerability of the investigational drug in SOD1-ALS patients and whether the investigational drug can reduce the total amount of SOD1 protein and slow down the progression of the disease
Treatment duration: 10 appointments at the study centre within approx. 32 weeks
Status of recruitment: Recruitment completed
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TUDCA-ALS (Phase 3 study)
Study title: Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as an add-on therapy in patients suffering from amyotrophic lateral sclerosis (ALS).
A multicentre, randomised, double-blind, placebo-controlled study.
Therapeutic substance: Tauroursodeoxycholic acid (TUDCA) 1g (4 capsules) 2x/day
Control: Placebo 4 caps. 2x/day
TUDCA 2g/day or placebo in a ratio of 1:1
Study objective: Previous studies show that TUDCA has a neuroprotective effect (protective effect for nerve cells and nerve fibres).
Duration of treatment: 9 appointments are planned at the study centre within 18 months.
Recruitment status: Recruitment completed
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ROCK-ALS (Phase 2 study)
Study title: Inhibition of Rho kinase (ROCK) with fasudil for the course-modifying treatment of ALS
Therapeutic exploratory, double-blind, dose-finding, randomised, placebo-controlled, international, multicentre, prospective, interventional phase 2a study.
Therapeutic agent: Fasudil IV
Study objective: To investigate whether the administration of fasudil slows down nerve cell death and thus has a neuroprotective or course-modifying effect
Treatment duration: Fasudil IV as a short infusion (intravenous) 2x/day for 21 days (daily in the morning and evening)
Arm A: 30 mg (2 x 15 mg)
Arm B: 60 mg (2 x 30 mg)
Arm C: placebo (2x placebo)
After the 21-day treatment phase, 3 further visits (after 3 weeks, 3 months, 6 months) without medication
Status of recruitment: Recruitment completed
Contact person:
Dementia / Alzheimer Team
Phone: 0731 / 500 63089
Fax: 0731 / 500 63009
Email: gedaechtnis.ambulanz@uniklinik-ulm.de
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Current studies
Here we present one study in more detail as an example.
CELIA
(Excerpt from the patient information leaflet)
We would like to introduce you to a clinical trial for patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia. The CELIA study is investigating a treatment option for Alzheimer's disease by focussing on a protein called tau. In Alzheimer's disease, the tau proteins change their shape and form so-called tau fibrils inside nerve cells, which impair the normal function and health of the neurones. We want to find out whether different doses of a study drug called BIIB080 have potential side effects and can influence the progression of Alzheimer's disease.
You may be eligible to participate in the CELIA study if you fulfil the following requirements:
- Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia.
- Age 50 - 80 years
Further criteria apply, which will be explained to you by your study team. You must also have a carer (sometimes called a study partner) who agrees to support you during the study. Your participation in the CELIA study will last approximately 2 years and will involve about 18 appointments at the study centre and 15 telephone follow-up appointments.
If you are eligible and decide to participate, you will be randomised (assigned at random) to one of 4 different study groups in which you will receive either the study drug or placebo. 3 study groups will receive different doses of the study drug and one study group will receive the placebo. Neither you nor your care partner or the study team will know which group you are in. You will receive your study drug or placebo by intrathecal injection via a lumbar puncture. With an intrathecal injection, the study drug is injected directly into the spinal fluid so that it can reach your brain and take effect there. A lumbar puncture is a common medical procedure in which a needle is inserted into the lower back (between the bones of the spine). You will receive an intrathecal injection via a lumbar puncture 7 times over the 2 years you are in the study.
Important:
Your health and safety are our top priority. You can leave this study at any time and for any reason. Participation is free of charge and you will be reimbursed for travelling expenses.
If you would like to find out more about the CELIA study, please contact the study team.
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Ansprechpartner:
FTLD Team
(Dr. Zeljko Uzelac und Dr. Sarah Anderl-Straub)
Tel.: 0731 / 500 63099
Fax: 0731 / 500 63009
Email: sarah.straub@uni-ulm.de
Rekrutierende Medikamentenstudien
Ansprechpartnerin:
Dr. Zeljko Uzelac / Dr. Karin Graf
Tel.: 0731 / 500 63099
Email: karin.graf@uni-ulm.de
Aktuelle Studien
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ALECTOR AL001-CS-302
Studientitel: „A Continuation Study of Latozinemab in Participants with Neurodegenerative Disease“
Therapiesubstanz: Latozinemab (AL001)
Zielgruppe: Patienten mit FTD und Granulin- oder C9orf72-Mutationen
Studienziel: Ziel der Studie ist es, Patienten, die bereits eine Studie mit Latozinemab abgeschlossen haben, weiterhin Zugang zu Latozinemab zu gewähren. In der Studie werden Sicherheit und Verträglichkeit einer Verabreichung von 60mg/kg Latozinemab (intravenös alle vier Wochen) untersucht.
Behandlungsdauer: Die Behandlung wird fortgeführt, bis Latozinemab in dem Land, in dem der Patient behandelt wird, zugelassen ist oder Sicherheitsbedenken eine weitere Behandlung unmöglich machen, der Patient oder sein gesetzlicher Vertreter ihre Einwilligung in die Studie widerrufen oder die Entwicklung von Latozinemab abgebrochen wird.
Rekrutierung: Rekrutierung abgeschlossen
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Registerstudien
FTLD-Netzwerk
Ansprechpartnerinnen:
Dr. Sarah Anderl-Straub und Leonie Werner
Tel.: 0731/ 500 63099
Studientitel: Konsortium zur Erforschung der frontotemporalen Lobärdegeneration
Zielgruppe: Patienten mit FTLD, gesunde Kontrollen
Studienziel: Entwicklung und Evaluation von Parametern für die Frühdiagnose und die Verlaufsbeobachtung von Patienten mit frontotemporaler Lobärdegeneration, um letztendlich eine objektive Zielgröße für therapeutische Strategien zu entwickeln
Rekrutierung: aktiv
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ALS-FTD-Schwabenregister
Ansprechpartnerin
Nicola Lämmle
Tel. 0173 3462115
Studientitel: Erfassung von ALS und FTLD-Erkrankungen in einem klinisch-epidemiologischen Register und Erhebung von Risikofaktoren im Rahmen einer Fall-Kontroll-Studie.
Zielgruppe: Patienten mit FTLD und ALS-FTD
Studienziel: Das Neuauftreten, den Verlauf und die Risikofaktoren der FTLD in Schwaben bei einem Hausbesuch zu erfassen und wissenschaftlich zu untersuchen.
Rekrutierung: aktiv
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Präklinische Genträgerstudie
Ansprechpartnerin:
Nicola Lämmle
Tel. 0173 3462115
Studientitel: Kohortenstudie zur präklinischen Charakterisierung von FTLD-Mutationsträgern
Zielgruppe: Angehörige von Patienten mit familiärer FTLD
Studienziel: Erforschung der Krankheitsentwicklung und Ursachen der genetischen FTLD. Die Studie ermöglicht eine Früherkennung, so dass neue Therapiemöglichkeiten, an denen derzeit intensiv geforscht wird, zeitiger und dadurch effektiver eingesetzt werden können
Rekrutierung: aktiv
Contact person:
Mrs Felicitas Becker
Tel.: 0731 / 177 5251
Fax: 0731 / 500 63009
Email: felicitas.becker@rku.de
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Contact:
MS Team
Phone: 0731 / 500 63021
Fax: 0731 / 500 63009
Email: ms.studienzentrum@uniklinik-ulm.de
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RED4MS
Studientitel:: „Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients with Relapsing Remitting Multiple Sclerosis - RED4MS trial“
Therapiesubstanz: Autologe rote Blutkörperchen (Eigenblut), die mit Eiweißen des zentralen Nervensystems gekoppelt werden, um eine Immuntoleranz zu induzieren
Zielgruppe: Patienten mit schubförmiger Multipler Sklerose (RMS) zwischen 18 und 55 JahrenPatienten mit schubförmiger Multipler Sklerose (RMS) zwischen 18 und 55 Jahren mit einer Krankheitsdauer unter 10 Jahren und klinische Schubaktivität oder MRT-Aktivität innerhalb der letzten 12 Monate
Studienziel: Die Untersuchung der Effektivität und Sicherheit von Eigenbluttransfusionen nach Kopplung von Eiweißen des zentralen Nervensystems auf die Oberfläche der roten Blutkörperchen.
Behandlungsdauer: 48 Wochen
Rekrutierung: aktiv
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cosMOG
Studientitel: „MOG001: Eine randomisierte, doppelblinde, placebokontrollierte, multizentrische Zulassungsstudie der Phase III mit unverblindeter Verlängerungsphase zur Beurteilung der Wirksamkeit und Sicherheit von Rozanolixizumab bei Erwachsenen mit Myelin-Oligodendrozyten-Glykoprotein-(MOG-)Antikörper-assoziierter Erkrankung (MOG-AD)"
Therapiesubstanz: Antikörper Rozanolixizumab (<70kg 420mg subkutan, >70kg 560mg subkutan) 1x Woche gegen Placebo (Randomisierung 1:1)
Zielgruppe: Patienten mit MOGAD (MOG-Antikörper-assoziierte Erkrankung des ZNS) zwischen 18 und 89 Jahren und einem Schubereignis in den letzten 12 Monaten
Studienziel: Die Untersuchung der Effektivität und Sicherheit von Rozanolixizumab um weiteren Schüben der MOGAD vorzubeugen
Studiendauer: ca. 24-48 Monate
Rekrutierung: aktiv
CYTB323N12101
Studientitel: „An open-label, multi-center, phase 1/2 study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with Relapsing Multiple Sclerosis with breakthrough disease activity during previous treatment with a highly efficacious therapy"
Therapiesubstanz: CAR-T-Zell-Präparat YTB323
Zielgruppe: Patienten mit hochaktiver schubförmigen MS zwischen 18 und 55 Jahren und einem Schubereignis oder MRT-Aktivität in den letzten 12 Monaten unter einer Immuntherapie mit B-Zell-Antikörpern (Rituximab, Ocrelizumab, Ofatumumab, Ublituximab) oder Natalizumab (Tysabri, Tyruko)
Studienziel: Die Untersuchung der Effektivität und Sicherheit von YTB323
Studiendauer: 24 Monate, Überwachung der langfristigen Sicherheit der Therapie für 12 Jahre
Rekrutierung: Beginn im 1. Quartal 2025 geplant
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CYTB323R12101
Studientitel: „An open-label, multi-center, phase I/II study to assess safety, disease progression, and cellular kinetics following YTB323 administration in participants with non-active Progressive Multiple Sclerosis (PMS)"
Therapiesubstanz: CAR-T-Zell-Präparat YTB323
Zielgruppe: Patienten mit progredienter MS zwischen 18 - 60 Jahren, einer Krankheitsdauer unter 15 Jahren, im letzten Jahr einer schubunabhängigen Zunahme des EDSS um ≥0,5 und keinem Schubereignis und erhaltener Gehfähigkeit (EDSS max. 6,5)
Studienziel: Die Untersuchung der Effektivität und Sicherheit von YTB323
Studiendauer: 24 Monate, Überwachung der langfristigen Sicherheit der Therapie für 12 Jahre
Rekrutierung: Beginn im 1.-2. Quartal 2025 geplant
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BP42230
Studientitel: „A Multiple-Center, Non-Randomized, Open-Label, Adaptive, Single-Ascending Dose (Part 1 And Part 2) And Multiple-Ascending Dose (Part 3) Parallel, Phase Ib Study To Investigate The Safety, Tolerability, Immunogenicity, Pharmacokinetics, And Pharmacodynamics Of RO7121932 Following Intravenous (Part 1) And Subcutaneous Administration (Parts 2 And 3) In Participants With Multiple Sclerosis"
Therapiesubstanz: RO7121932 (Typ II anti-CD20-Antikörper, intravenös oder subkutan) fusioniert mit einem Brain-Shuttle-Modul, dass an dem humanen Transferrin-Rezeptor 1 (TfR1) bindet.
Zielgruppe: Patienten mit schubförmiger oder progredienter MS zwischen 18 - 65 Jahren und einem max. EDSS von 7,0. Kein Schubereignis in den letzten 3 Monaten vor Studieneinschluss, nicht >2 Schubereignisse im letzten Jahr.
Studienziel: Die Untersuchung Sicherheit von BP42230 und Dosisfindung
Studiendauer: 18 Wochen, Überwachung bis zu 29 Wochen
Rekrutierung: Beginn im 1. Quartal 2025 geplant
FENHANCE
Studientitel: „A Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of Fenebrutinib compared with Teriflunomide in adult patients with Relapsing Multiple Sclerosis“
Therapiesubstanz: BTK-Inhibitor Fenebrutinib vs. Teriflunomid (je 2x2 und 1 Tbl. / d)
Zielgruppe: Patienten mit schubförmiger Multipler Sklerose (RMS) zwischen 18 und 55 Jahren
Studienziel: Die Überprüfung von Effektivität und Sicherheit des BTK-Inhibitors Fenebrutinib bei der Behandlung der schubförmigen Multiplen Sklerose
Behandlungsdauer: 24-48 Monate
Rekrutierung: Rekrutierung abgeschlossen
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PERSEUS
Studientitel: „A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)“
Zielgruppe: Patienten mit primär progredienten Multiplen Sklerose (PPMS) zwischen 18 und 55 Jahren
Therapiesubstanz: BTK-Inhibitor Tolebrutinib (SAR442168) vs Placebo (je 1 Tablette pro Tag)
Studienziel: Die Überprüfung von Effektivität und Sicherheit des BTK-Inhibitors Tolebrutinib bei der Behandlung der primär-progredienten Multiplen Sklerose
Behandlungsdauer: 24-48 Monate
Rekrutierung: Rekrutierung abgeschlossen
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LTS17043 (Nachfolgestudie GEMINI-1, HERCULES und PERSEUS)
Studientitel: „An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis“
Therapiesubstanz: Tolebrutinib 60mg/d, Open-Labelbehandlung
Zielgruppe: Teilnehmer der Studien GEMINI-1, HERCULES und PERSEUS
Studienziel: Erfassung von Langzeiteffektivitäts- und Sicherheitsdaten der Behandlung von MS-Patientin mit Tolebrutinib
Studiendauer: 36 Monate
Rekrutierung: keine aktive Rekrutierung
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MUSETTE
Studientitel: „A Phase IIIb multicenter, randomized, double-Blind, controlled Study to evaluate the efficacy, safety And pharmacokinetics of a higher dose of Ocrelizumab In adults with relapsing Multiple Sclerosis“
Therapiesubstanz: verblindet, Ocrelizumab High dose (gewichtsadaptiert, >75kg 1800mg, <75kg 1200mg) vs. Ocrelizumab in zugelassener Dosis (600mg) alle 6 Monate
Zielgruppe: Patienten mit schubförmigen multiplen Sklerose (RRMS) zwischen 18 und 55 Jahren
Rekrutierung: abgeschlossen
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OLERO
Studientitel: „A multicenter, single-arm, open-label, extension, rollover study to evaluate the long-term safety and efficacy of Ocrelizumab in patients with Multiple Sclerosis“
Therapiesubstanz: Ocrelizumab 600mg alle 6 Monate
Rekrutierung: abgeschlossen
MSFP-Register
Studientitel: Der Bundesverband der Deutschen Multiple Sklerose Gesellschaft (DMSG) initiierte 2001 den Aufbau eines MS-Registers für Deutschland mit dem Ziel, verlässliche Daten zur Multiplen Sklerose zu erfassen, etwa zu klinischen Charakteristika der MS, soziodemographischen Aspekten und zur Versorgungssituation der MS-Erkrankten.
Zielgruppe: Einwilligungsfähige Patienten mit Diagnose einer Multiplen Sklerose
Rekrutierung: aktiv
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NEMOS:
Studientitel: Die Neuromyelitis optica Studiengruppe (nachfolgend NEMOS abgekürzt) ist eine Initiative von Ärzten aus etwa 25 Kliniken in ganz Deutschland, die sich zum Ziel gesetzt hat, die Kenntnisse über die NMO (früher auch Devic-Syndrom) zu erweitern und damit die Diagnostik und Therapie der von dieser Erkrankung betroffenen Patienten zu verbessern. Mittlerweile konnte NEMOS wichtige Erkenntnisse über den Verlauf der Erkrankung und die Wirksamkeit von Therapien bei NMO-Patienten erheben. Darüber hinaus konnten die diagnostischen Tests verbessert werden, so dass die NMO und ihre Varianten (sogenannte NMO-Spektrum-Erkrankungen/NMOSD) noch besser von der MS abgegrenzt werden können (vor allem bei den Patienten, die keinen NMO-spezifischen Antikörper-Befund haben). (Quelle: nemos-net.de)
Zielgruppe: Patienten mit Neuromyelitis optica-Spektrum-Erkrankungen oder mit MOG-Antikörper-assoziierten Erkrankungen des ZNS
Rekrutierung: aktiv
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ProVal-MS im Rahmen von DiFuture
Studientitel: „Prospective study to validate a multidimensional treatment decision score (DIFUTURE-MS-TDS) which predicts the 24 month outcome in untreated patients with Clinically Isolated Syndrome and early Relapsing-Remitting Multiple Sclerosis under specific treatment options“
Zielgruppe: Patienten mit schubförmiger Multiplen Sklerose (RRMS), mit Erstdiagnose max. vor 2 Jahren und vor Einleitung einer Immuntherapie, zwischen 18 und 55 Jahren
Studienziel: Entwicklung eines Scores zur Optimierung der Therapieauswahl bei neu diagnostizierten Patienten mit schubförmiger Multipler Sklerose
Rekrutierung: Rekrutierung abgeschlossen
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CONFIDENCE
Studientitel: „Safety and effectiveness of Ocrelizumab under real world conditions: a noninterventional post authorization safety study in patients diagnosed with relapsing or primary progressive Multiple Sclerosis - CONFIDENCE“
Studienziel: Langzeitstudie zur Überprüfung von Sicherheit und Wirksamkeit von Ocrelizumab im Vergleich zu weiteren zugelassenen Therapien (Natalizumab, Fingolimod, Cladribin,Teriflunomid, Dimethylfumarat)
Rekrutierung: abgeschlossen
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EmBioPro
Studientitel: „Explorative study of emerging blood biomarkers in progressive multiple sclerosis“
Zielgruppe: Patienten mit progredienten Erkrankungsformen der Multiplen Sklerose (PPMS, SPMS)
Studienziel: Offene, prospektive Beobachtungsstudie zur Charakterisierung des Krankheitsverlaufs bei Patienten mit progredienten Formen der Multiplen Sklerose
Rekrutierung: abgeschlossen
Contact person:
Mrs Hela Jerbi
Phone: 0731 /500 63080
Fax: 0731 /500 63082
Email: hela.jerbi@uniklinik-ulm.de
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Current studies
IONIS 443139-CS1
Type of study: Randomised, double-blind, placebo-controlled drug study
Aim: Assessment of safety, tolerability and efficacy
Sponsor: IONIS
Investigational drug: IONIS 443139
Phase: Phase II
Target group: People with early-stage Huntington's disease
Number of visits: 18 (within a period of about 9 months)
Eudra-CT No: 2015-000381-66
Status of recruitment: Recruitment completed
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Enroll-HD study
Type of study: Observational study
Aim: Collection of data for research into Huntington's disease
Sponsor: CHDI Foundation
Target group: People
- -with Huntington's disease
- -who come from a family with Huntington's disease
- -who do not come from a family with Huntington's disease
- and do not carry the Huntington's gene (control person)
Number of visits: One visit per year
Recruitment status: Inclusion in the study possible at any time
Contact:
Mr Ralf Nille
Phone: 0731 / 177 5387
Fax: 0731 / 500 63009
Email: ralf.nille@uniklinik-ulm.de
Current studies
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Cardiovascular risk factors and atheromatosis in SBMA Kennedy
Type of study: Monocentric open observational study
Theaim is to find out whether high cholesterol levels in SBMA patients need to be lowered or whether the patients are protected against arteriosclerosis as part of their disease/hormone changes
Sponsor: Ulm University Hospital
Investigational drug: none
Intervention: Cardiac CT, cerebral MRI, ultrasound of the arteries, blood sampling, ocular fundus photograph
Target group: spinobulbar muscular atrophy Kennedy
Number of visits: 1
Contact: angela.rosenbohm@uni-ulm.de
Recruitment status: Inclusion in the study possible at any time
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IgPro 20 Recaliim
Type of study: Prospective, multicentre, randomised study in dermatomyositis
Theaim is to find out whether the additional subcutaneous administration of immunoglobulins controls the symptoms
Sponsor: CSL Behring
Investigational drug: IgPro 20 (subcutaneous immunoglobulin) vs. guideline-compliant dermatomyositis standard therapy
Phase: 3
Target group: Dermatomyositis
Number of visits: 16 in 1 year
Eudra-CT No: 2018-003171-35
Recruitment status: Inclusion in the study from spring 2023
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Fulcrum REACH
Type of study: Prospective, multicentre, randomised, double-blind study
Theaim is to find out whether losmapimod can stop muscle wasting by blocking DUX protein formation and stabilise paralysis
Sponsor: Fulcrum Therapeutics
Investigational drug: Losmapimod
Phase: 3
Target group: facioscapulohumeral muscular dystrophy FSHD 1 and 2, 18-65 years of age
Number of visits: 8, within 1 year
Eudra-CT No: 2022-000389-16
Status of recruitment: Recruitment completed
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ARGX-113
Type of study: Prospective, multicentre, randomised, double-blind study in myositis
Theaim is to find out whether the additional treatment with efgartigimod prevents the formation of antibodies in myositis and thus alleviates the symptoms of muscle weakness and possibly skin symptoms
Sponsor: Argenx
Investigational drug: Efgartigimod subcutaneous vs. guideline-compliant standard myositis therapy
Phase: 3
Target group: Myositis
Number of visits: 15-17, 10 per 24 weeks
Eudra-CT No: 2021-001277-23
Recruitment status: Inclusion in the study possible from summer 2023
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Viela Bio MINT
Type of study: Prospective, multicentre, randomised, double-blind study in myasthenia gravis
Theaim is to find out whether the additional administration of inebilizumab brings about a clinical improvement in generalised myasthenia gravis
Sponsor: Viela Bio
Investigational drug: Inebilizumab
Phase: 3
Target group: Antibody-positive generalised myasthenia gravis
Number of visits: 12-13
Eudra-CT No: 2020-000949-14
Recruitment status: Inclusion in the study from spring 2023
Contact:
Mrs Julia Seifert
Phone: 0731 /177 5250
Fax: 0731 / 500 63009
Email: julia.seifert@uniklinik-ulm.de
Contact:
Mrs Andrea Schirmer
Phone: 0731 / 177 5274
Fax: 0731 / 500 63009
Email: andrea.schirmer@uni-ulm.de
Current studies
FIND-AF2
Study title: Intensified rhythm monitoring for the prevention of ischaemic strokes and systemic embolisms.
Short description: Interventional multicentre randomised, open, parallel controlled study with the aim of reducing recurrent strokes through more intensive and prolonged monitoring of the heartbeat
Target group: acute non-cardioembolic ischaemic stroke
Number of visits: 3 months after inclusion, then every 12 months, semi-annual telephone contact; study duration: at least 24 months to 72 months
Identification number: NCT04371055
Sponsor: University of Leipzig
Status of recruitment: Recruitment until 30.06.2024
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OCEANIC-Stroke
Study title: Stroke prevention in patients after a high-risk ischaemic stroke or transient ischaemic attack.
Short description: A multicentre, international, randomised, placebo-controlled, double-blind, event-driven, parallel-group study. The aim is to find out whether the addition of asundexiant to standard therapy reduces the risk of a further stroke.
Target group: acute non-cardioembolic ischaemic stroke or high-risk TIA
Investigational drug: oral FXIa inhibitor asundexiane (BAY 2433334) vs. placebo
Phase: 3
Number of visits: 5 visits on site, telephone contact at regular intervals; study duration: 27 months
Eudra-CT No: 2022-001667-27
Sponsor: Bayer AG
Recruitment status: Inclusion possible at any time
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ODEATIA
Study title: Optimal detection of atrial fibrillation in transient ischaemic attacks
Short description: prospective, randomised, open, multicentre observational study comparing different methods of long-term ECG recording
Target group: Detection of atrial fibrillation after TIA
Number of visits: 6 (within a period of approx. 2 years)
Identification number: NCT04075500
Sponsor: Altried Krupp von Bohlen und Halbach Krankenhaus gemeinnützige GmbH
Status of recruitment: Recruitment completed
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PRESTIGE-AF
Study title: Stroke prevention in patients with intracerebral haemorrhage and atrial fibrillation
Short description: Investigator-led, multicentre, parallel-group, prospective, randomised, open-label study; aim is to investigate the safety of the use of anticoagulant medication in patients with intracerebral haemorrhage and atrial fibrillation for the prevention of stroke
Target group: intracerebral haemorrhage and atrial fibrillation
Investigational drug: anticoagulant medication (anticoagulation, intervention group) vs. no anticoagulant medication (control group)
Phase: 3b
Number of visits: 6 (within a period of approximately 1 year, extension to 3 years possible)
Eudra-CT No: 2018-002176-41
Sponsor: Imperial College of Science, Technology and Medicine
Status of recruitment: Recruitment completed
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REVISION
Study title: Early reperfusion therapy with intravenous alteplase to restore visual function in acute central retinal artery occlusion
Short description: Double-blind and placebo-controlled clinical study; the aim of the study is to demonstrate the efficacy and safety of intravenous reperfusion therapy for central retinal artery occlusion
Target group: Central retinal artery occlusion (≤ 4.5 hours after symptom onset).
Investigational drug: alteplase vs. placebo
Phase: 3
Number of visits: 4 visits Study duration: 90 days
Eudra-CT No: 2021-000183-29
Sponsor: University Hospital Tübingen
Recruitment status: Inclusion possible at any time
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Biomarker microangiopathy study
Short description: monocentric observational study to identify blood biomarkers for the progression assessment of cerebral microangiopathy
Target group: patients with sporadic cerebral microangiopathy with or without recent cerebral ischaemia
Number of visits: 4
Sponsor: Investigator initiated study
Status of recruitment: Inclusion possible at any time
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IN PREPARATION
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FASTEST
Study title: Recombinant factor VIIa in acute haemorrhagic stroke administered at the earliest possible time point
Brief description: Comparison of clinical course of the patient after administration of rFVIIa after haemorrhage event vs. placebo
Target group: spontaneous intracerebral haemorrhage(≤ 2 hours)
Investigational drug: rFVIIa (NovoSeven) vs. placebo
Phase: 3
Number of visits: after inpatient discharge 3 visits on site, study duration: 180 days
Eudra-CT No: 2019-003722-25
Sponsor: NIH StrokeNet National Coordinating Centre at the University of Cincinnati
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Librexia Stroke
Study title: Stroke prevention in patients after a high-risk ischaemic stroke or transient ischaemic attack.
Abstract: A phase 3, randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of milvexian, an oral Factor XIa inhibitor, after an ischaemic stroke or high-risk transient ischaemic attack. The aim is to find out whether the additional administration of Milvexian to standard therapy reduces the risk of a further stroke.
Target group: acute non-cardioembolic stroke or high-risk TIA
Investigational drug: BMS-986177 Milvexian vs. placebo
Phase: 3
Number of visits: after inpatient discharge 3 visits on site, study duration: 30 months
Eudra-CT No: 2022-501176-26-00
Sponsor: Janssen Research & Development, LLC
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REVERXaL
Short description: A multinational observational longitudinal study to describe patient characteristics, healthcare interventions and health outcomes of patients with major bleeding while receiving concomitant treatment with a Factor Xa inhibitor, inclusion in two cohorts; Cohort A: bleeding and ongoing treatment with an FXa inhibitor, Cohort B: bleeding+ ongoing treatment with an FXa inhibitor + reversal
Target group: severe haemorrhage
Phase: observational longitudinal study
Number of visits: Cohort B: 2 visits, study duration: 90 days
Sponsor: AstraZeneca AB
Links
- Forwarding to the German ALS Study Group: here
Contact us
Study Centre Clinic for Neurology
University Hospital Ulm
Oberer Eselsberg 45
89081 Ulm