Amsterdam UMC, location VUmc — Biomedical Watch V2

Traitements6programmes

Essais5liés

Publications0liées

SourceDBlocale

Traitements

6

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
AZD0530 DifumarateThis is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment with historical control data. Study population: Male and female adult patients aged 18 years and older with a diagnosis of FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for participation in this study. The total number of enrolled patients will be 20. Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or matched placebo, taken orally for the first 6 months, immediately followed by an open-label extension in which all patients will receive AZD0530 100mg once daily oral dose for a further 12 months. Endpoints: Endpoints include change in number of active heterotopic bone lesions measured by low-dose whole-body computer tomography (CT)/ \[18F\] NaF Positron Emission Tomography (PET) activity	Myopathies	Phase 2	À vérifier	Germany, Netherlands, United Kingdom	À vérifier
LUCASVP — Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?To give chest compressions during cardiopulmonary resuscitation (CPR), mechanical chest compression devices can be used. During synchronous 30:2 CPR, the standard setting on these devices leave an automated 3-second chest compression pause after 30 compressions to facilitate caregivers in providing two ventilations. With this standard setting, research has shown that in less than half of ventilation pauses during CPR, those two ventilations are given. Increasing the ventilation pause duration to 5 seconds instead of 3 seconds is also an option following current guideline recommendations, and aligns with measured ventilation pause duration in manual CPR. Increasing pause duration to 5 seconds could result in an increased ventilation success rate. This multicenter randomized controlled trial will randomize LUCAS® mechanical compression devices to a standard setting of 3- or 5-second compression pauses. The main outcome will be the percentage of ventilation pauses in which two ventilations are successfully given. Secondary outcomes include the restoration of spontaneous circulation (ROSC), and the difference in (neurologically intact) survival. No study has been performed to evaluate this effect yet.	Sclérose latérale amyotrophique	Non applicable	À vérifier	Netherlands	À vérifier
WOC — The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple SclerosisThe primary goal of this research is to study the prevalence of the wearing-off effect and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab with the use of questionnaires. Furthermore, the goal is to study whether patients receiving extended dosing of ocrelizumab experience more wearing-off symptoms or adverse events in general. Finally, we would like to extend knowledge on wearing-off symptoms in general.	SEP	À vérifier	Traitement symptomatique	Netherlands	À vérifier
WOC — The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple SclerosisThe primary goal of this research is to study the prevalence of the wearing-off effect and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab with the use of questionnaires. Furthermore, the goal is to study whether patients receiving extended dosing of ocrelizumab experience more wearing-off symptoms or adverse events in general. Finally, we would like to extend knowledge on wearing-off symptoms in general.	SEP	À vérifier	Traitement symptomatique	Netherlands	À vérifier
LUCASVP — Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?To give chest compressions during cardiopulmonary resuscitation (CPR), mechanical chest compression devices can be used. During synchronous 30:2 CPR, the standard setting on these devices leave an automated 3-second chest compression pause after 30 compressions to facilitate caregivers in providing two ventilations. With this standard setting, research has shown that in less than half of ventilation pauses during CPR, those two ventilations are given. Increasing the ventilation pause duration to 5 seconds instead of 3 seconds is also an option following current guideline recommendations, and aligns with measured ventilation pause duration in manual CPR. Increasing pause duration to 5 seconds could result in an increased ventilation success rate. This multicenter randomized controlled trial will randomize LUCAS® mechanical compression devices to a standard setting of 3- or 5-second compression pauses. The main outcome will be the percentage of ventilation pauses in which two ventilations are successfully given. Secondary outcomes include the restoration of spontaneous circulation (ROSC), and the difference in (neurologically intact) survival. No study has been performed to evaluate this effect yet.	Sclérose latérale amyotrophique	Non applicable	À vérifier	Netherlands	À vérifier
AZD0530 DifumarateThis is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment with historical control data. Study population: Male and female adult patients aged 18 years and older with a diagnosis of FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for participation in this study. The total number of enrolled patients will be 20. Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or matched placebo, taken orally for the first 6 months, immediately followed by an open-label extension in which all patients will receive AZD0530 100mg once daily oral dose for a further 12 months. Endpoints: Endpoints include change in number of active heterotopic bone lesions measured by low-dose whole-body computer tomography (CT)/ \[18F\] NaF Positron Emission Tomography (PET) activity	Myopathies	Phase 2	À vérifier	Germany, Netherlands, United Kingdom	À vérifier

Essais cliniques

5

Molécule	Indication / population	Phase	NCT	Titre	Statut
AZD0530 Difumarate	Myopathies	Phase 2	NCT04307953	STOPFOP — Saracatinib Trial TO Prevent FOP	ACTIVE_NOT_RECRUITING
LUCASVP — Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?	Sclérose latérale amyotrophique	Non applicable	NCT06824961	LUCASVP — Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?	RECRUITING
Clemastine Fumarate	SEP	Phase 3	NCT05338450	RESTORE — Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis	TERMINATED
Rituximab	SEP	Phase 3	NCT05834855	Noisy Rebels — Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS	RECRUITING
WOC — The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple Sclerosis	SEP	À vérifier	NCT04478591	WOC — The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple Sclerosis	COMPLETED

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.