A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping
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A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping. / Kerschbaumer, Johannes; Freyschlag, Christian Franz; Petr, Ondra; Adage, Tiziana; Breitenbach J, Joerg; Wessels, Lars; Wolf, Stefan; Hecht, Nils; Gempt, Jens; Wostrack, Maria; Gmeiner, Matthias; Gollwitzer, Maria; Stefanits, Harald; Bendszus M, Martin; Gruber, Andreas; Meyer, Bernhard; Vajkoczy, Peter; Thomé, Claudius.
in: BRAIN SPINE, Jahrgang 3, 2023, S. 102673.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping
AU - Kerschbaumer, Johannes
AU - Freyschlag, Christian Franz
AU - Petr, Ondra
AU - Adage, Tiziana
AU - Breitenbach J, Joerg
AU - Wessels, Lars
AU - Wolf, Stefan
AU - Hecht, Nils
AU - Gempt, Jens
AU - Wostrack, Maria
AU - Gmeiner, Matthias
AU - Gollwitzer, Maria
AU - Stefanits, Harald
AU - Bendszus M, Martin
AU - Gruber, Andreas
AU - Meyer, Bernhard
AU - Vajkoczy, Peter
AU - Thomé, Claudius
N1 - © 2023 The Authors.
PY - 2023
Y1 - 2023
N2 - INTRODUCTION: Aneurysmal subarachnoid hemorrhage (aSAH) is associated with high morbidity and mortality. Post-hemorrhagic vasospasm with neurological deterioration is a major concern in this context. NicaPlant®, a modified release formulation of the calcium channel blocker nicardipine, has shown vasodilator efficacy preclinically and a similar formulation known as NPRI has shown anti-vasospasm activity in aSAH patients under compassionate use.RESEARCH QUESTION: The study aimed to assess pharmacokinetics and pharmacodynamics of NicaPlant® pellets to prevent vasospasm after clip ligation in aSAH.MATERIAL AND METHODS: In this multicenter, controlled, randomized, dose escalation trial we assessed the safety and tolerability of NicaPlant®. aSAH patients treated by clipping were randomized to receive up to 13 NicaPlant® implants, similarly to the dose of NPRIs previous used, or standard of care treatment.RESULTS: Ten patients across four dose groups were treated with NicaPlant® (3-13 implants) while four patients received standard of care. 45 non-serious and 13 serious adverse events were reported, 4 non-serious adverse events and 5 serious adverse events assessed a probable or possible causal relationship to the investigational medical product. Across the NicaPlant® groups there was 1 case of moderate vasospasm, while in the standard of care group there were 2 cases of severe vasospasm.DISCUSSION AND CONCLUSION: The placement of NicaPlant® during clip ligation of a ruptured cerebral aneurysm raised no safety concern. The dose of 10 NicaPlant® implants was selected for further clinical studies.
AB - INTRODUCTION: Aneurysmal subarachnoid hemorrhage (aSAH) is associated with high morbidity and mortality. Post-hemorrhagic vasospasm with neurological deterioration is a major concern in this context. NicaPlant®, a modified release formulation of the calcium channel blocker nicardipine, has shown vasodilator efficacy preclinically and a similar formulation known as NPRI has shown anti-vasospasm activity in aSAH patients under compassionate use.RESEARCH QUESTION: The study aimed to assess pharmacokinetics and pharmacodynamics of NicaPlant® pellets to prevent vasospasm after clip ligation in aSAH.MATERIAL AND METHODS: In this multicenter, controlled, randomized, dose escalation trial we assessed the safety and tolerability of NicaPlant®. aSAH patients treated by clipping were randomized to receive up to 13 NicaPlant® implants, similarly to the dose of NPRIs previous used, or standard of care treatment.RESULTS: Ten patients across four dose groups were treated with NicaPlant® (3-13 implants) while four patients received standard of care. 45 non-serious and 13 serious adverse events were reported, 4 non-serious adverse events and 5 serious adverse events assessed a probable or possible causal relationship to the investigational medical product. Across the NicaPlant® groups there was 1 case of moderate vasospasm, while in the standard of care group there were 2 cases of severe vasospasm.DISCUSSION AND CONCLUSION: The placement of NicaPlant® during clip ligation of a ruptured cerebral aneurysm raised no safety concern. The dose of 10 NicaPlant® implants was selected for further clinical studies.
U2 - 10.1016/j.bas.2023.102673
DO - 10.1016/j.bas.2023.102673
M3 - SCORING: Journal article
C2 - 38021019
VL - 3
SP - 102673
JO - BRAIN SPINE
JF - BRAIN SPINE
SN - 2772-5294
ER -