NicaPlant (nicardipine) / BIT Pharma - LARVOL DELTA

A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping. (PubMed, Brain Spine) - "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."

Journal • PK/PD data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Subarachnoid Hemorrhage • Vascular Neurology

A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping (CNS Mission 2022) - No abstract available

Clinical • Cardiovascular • Subarachnoid Hemorrhage

A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping (clinicaltrials.gov) - P2b | N=40 | Active, not recruiting | Sponsor: BIT Pharma GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Feb 2023 | Trial primary completion date: Nov 2021 ➔ Apr 2022

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping (clinicaltrials.gov) - P2b; N=40; Recruiting; Sponsor: BIT Pharma GmbH; Trial completion date: Apr 2022 ➔ Nov 2022; Trial primary completion date: Apr 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

In vitro and in vivo testing of a novel local nicardipine delivery system to the brain: a preclinical study. (PubMed, J Neurosurg) - "Despite all efforts, the calcium channel antagonist nimodipine remains the only drug approved for improving outcomes after aSAH...NicaPlant provides continuous in vitro release of nicardipine over a 3-week observation period. In vivo testing confirmed vasoactivity and lack of toxicity. The local application of this novel nicardipine delivery system to the subarachnoid space is a promising tool to improve patient outcomes while avoiding systemic side effects."

Journal • Preclinical • Cardiovascular • CNS Disorders • Critical care • Hematological Disorders • Hypotension • Subarachnoid Hemorrhage

A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping (clinicaltrials.gov) - P2b; N=40; Recruiting; Sponsor: BIT Pharma GmbH

Clinical • New P2b trial