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A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping

Standard

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, Vol. 3, 2023, p. 102673.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Kerschbaumer, J, Freyschlag, CF, Petr, O, Adage, T, Breitenbach J, J, Wessels, L, Wolf, S, Hecht, N, Gempt, J, Wostrack, M, Gmeiner, M, Gollwitzer, M, Stefanits, H, Bendszus M, M, Gruber, A, Meyer, B, Vajkoczy, P & Thomé, C 2023, 'A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping', Brain & spine, vol. 3, pp. 102673. https://doi.org/10.1016/j.bas.2023.102673

APA

Kerschbaumer, J., Freyschlag, C. F., Petr, O., Adage, T., Breitenbach J, J., Wessels, L., Wolf, S., Hecht, N., Gempt, J., Wostrack, M., Gmeiner, M., Gollwitzer, M., Stefanits, H., Bendszus M, M., Gruber, A., Meyer, B., Vajkoczy, P., & Thomé, C. (2023). A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping. Brain & spine, 3, 102673. https://doi.org/10.1016/j.bas.2023.102673

Vancouver

Kerschbaumer J, Freyschlag CF, Petr O, Adage T, Breitenbach J J, Wessels L et al. A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping. Brain & spine. 2023;3:102673. https://doi.org/10.1016/j.bas.2023.102673

Bibtex

@article{ab433a8a121e4eb1a612c596519c6ae6,
title = "A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant{\textregistered} in aneurysmal subarachnoid hemorrhage patients undergoing clipping",
abstract = "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{\textregistered}, 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{\textregistered} 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{\textregistered}. aSAH patients treated by clipping were randomized to receive up to 13 NicaPlant{\textregistered} 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{\textregistered} (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{\textregistered} 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{\textregistered} during clip ligation of a ruptured cerebral aneurysm raised no safety concern. The dose of 10 NicaPlant{\textregistered} implants was selected for further clinical studies.",
author = "Johannes Kerschbaumer and Freyschlag, {Christian Franz} and Ondra Petr and Tiziana Adage and {Breitenbach J}, Joerg and Lars Wessels and Stefan Wolf and Nils Hecht and Jens Gempt and Maria Wostrack and Matthias Gmeiner and Maria Gollwitzer and Harald Stefanits and {Bendszus M}, Martin and Andreas Gruber and Bernhard Meyer and Peter Vajkoczy and Claudius Thom{\'e}",
note = "{\textcopyright} 2023 The Authors.",
year = "2023",
doi = "10.1016/j.bas.2023.102673",
language = "English",
volume = "3",
pages = "102673",
journal = "Brain & spine",
issn = "2772-5294",

}

RIS

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 -