KU Leuven — Biomedical Watch V2

Traitements10programmes

Essais6liés

Publications3liées

SourceDBlocale

Traitements

10

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
ClioquinolIn this exploratory trial, the potential anti-seizure activity of clioquinol in a small cohort of adolescents with drug-resistant epilepsy will be examined. Subjects will be exposed to clioquinol add-on for a period of maximum 8 weeks (2 weeks low dose, 6 weeks higher dose). The main hypothesis of the study is that 30% of the included subjects will be responders and that the median seizure frequency reduction will be at least 30%.	Épilepsie	Phase 2	À vérifier	Belgium	À vérifier
fenfluramineThe primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.	Épilepsie	Phase 2	À vérifier	Belgium	À vérifier
Point-of-Care high-sensitivity troponin testingThe goal of this study is to evaluate whether a POC-guided testing strategy to exclude non-ST elevation myocardial infarction (NSTEMI) in acute chest pain patients presenting at the emergency department (ED) can result in a shorter length of stay compared to the routine central laboratory testing strategy. Currently, most often two high-sensitivity troponin (hs-cTn) tests are required for exclusion of NSTEMI, and central laboratories are struggling to achieve the recommended turnaround time of 60 minutes. Novel POC hs-cTn testing technology can provide results in minutes, potentially reducing the ED length of stay. This may lead to a reduction in ED crowding, which is a growing worldwide healthcare problem, resulting in poorer patient outcomes. This study may therefore improve patient burden, ED staff workload, and lead to more efficient expenditure of healthcare resources. We will perform a prospective, cross-sectional, interventional, single-center, open label, randomized trial. All consecutive patients older than 18 years and younger than 75 years presenting at the UZ Leuven emergency department with chest pain or chest pain-equivalent symptoms suspected of an acute coronary syndrome (ACS) will be invited to participate in the study. After informed consent patients will be randomized into the point-of-care testing (POCT) group or the usual care group. Patients in the POCT group will undergo the novel POC test-guided strategy. In the POC strategy the first hs-cTnI test shortly after admission to the ED will be performed on the POC Atellica VTLi. The second test will be performed with the usual central laboratory hs-cTnT test. Patients in the usual care group will undergo the usual testing strategy with one or two hs-cTnT tests performed in the hospital's central laboratory.	Maladie coronarienne	Non applicable	Traitement symptomatique	Belgium	À vérifier
SBT FOG-TRAIN — Split-belt Treadmill Training for Freezing of Gait in Parkinson's DiseaseA split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.	Parkinson	Non applicable	À vérifier	Belgium	À vérifier
fenfluramineThe primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.	Épilepsie	Phase 3	À vérifier	United States, Belgium, Germany, Italy, United Kingdom	À vérifier
SBT FOG-TRAIN — Split-belt Treadmill Training for Freezing of Gait in Parkinson's DiseaseA split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.	Parkinson	Non applicable	À vérifier	Belgium	À vérifier
fenfluramineThe primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.	Épilepsie	Phase 4	À vérifier	Spain	À vérifier
ClioquinolIn this exploratory trial, the potential anti-seizure activity of clioquinol in a small cohort of adolescents with drug-resistant epilepsy will be examined. Subjects will be exposed to clioquinol add-on for a period of maximum 8 weeks (2 weeks low dose, 6 weeks higher dose). The main hypothesis of the study is that 30% of the included subjects will be responders and that the median seizure frequency reduction will be at least 30%.	Épilepsie	Phase 2	À vérifier	Belgium	À vérifier
fenfluramineThe primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.	Épilepsie	Phase 2	À vérifier	Belgium	À vérifier
Point-of-Care high-sensitivity troponin testingThe goal of this study is to evaluate whether a POC-guided testing strategy to exclude non-ST elevation myocardial infarction (NSTEMI) in acute chest pain patients presenting at the emergency department (ED) can result in a shorter length of stay compared to the routine central laboratory testing strategy. Currently, most often two high-sensitivity troponin (hs-cTn) tests are required for exclusion of NSTEMI, and central laboratories are struggling to achieve the recommended turnaround time of 60 minutes. Novel POC hs-cTn testing technology can provide results in minutes, potentially reducing the ED length of stay. This may lead to a reduction in ED crowding, which is a growing worldwide healthcare problem, resulting in poorer patient outcomes. This study may therefore improve patient burden, ED staff workload, and lead to more efficient expenditure of healthcare resources. We will perform a prospective, cross-sectional, interventional, single-center, open label, randomized trial. All consecutive patients older than 18 years and younger than 75 years presenting at the UZ Leuven emergency department with chest pain or chest pain-equivalent symptoms suspected of an acute coronary syndrome (ACS) will be invited to participate in the study. After informed consent patients will be randomized into the point-of-care testing (POCT) group or the usual care group. Patients in the POCT group will undergo the novel POC test-guided strategy. In the POC strategy the first hs-cTnI test shortly after admission to the ED will be performed on the POC Atellica VTLi. The second test will be performed with the usual central laboratory hs-cTnT test. Patients in the usual care group will undergo the usual testing strategy with one or two hs-cTnT tests performed in the hospital's central laboratory.	Maladie coronarienne	Non applicable	Traitement symptomatique	Belgium	À vérifier

Essais cliniques

6

Molécule	Indication / population	Phase	NCT	Titre	Statut
Point-of-Care high-sensitivity troponin testing	Maladie coronarienne	Non applicable	NCT06845826	CERMIT — Point-of-Care Troponin Testing in the Emergency Department	ACTIVE_NOT_RECRUITING
fenfluramine	Épilepsie	Phase 2	NCT02655198	FFA-LGS — Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy	COMPLETED
Clioquinol	Épilepsie	Phase 2	NCT05727943	CLIOKID — Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study	COMPLETED
fenfluramine	Épilepsie	Phase 4	NCT05232630	FENDEEP — Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes	COMPLETED
SBT FOG-TRAIN — Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease	Parkinson	Non applicable	NCT05511597	SBT FOG-TRAIN — Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease	COMPLETED
fenfluramine	Épilepsie	Phase 3	NCT06118255	ORCHID — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome	COMPLETED

Publications

3

Molécule	Indication / population	Titre	Journal	Date
fenfluramine		Beyond seizures: proceedings of the ERN EpiCARE working group 18 on developmental and epileptic encephalopathies.	Epilepsy & behavior : E&B
fenfluramine		Comparative diagnostic accuracy of panic provocation tests: A meta-analysis.	Journal of psychiatric research
fenfluramine		Fenfluramine for seizures in Dravet syndrome and Lennox-Gastaut syndrome: Mechanisms, clinical evidence, safety, and practical integration.	Epilepsy & behavior reports