A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping

Summary

This study of NicaPlant® is conducted in patients who have a subarachnoid haemorrhage. Patients will be randomized in two treatment groups. Both groups will receive the standard of care and the investigational group will receive in addition NicaPlant®. NicaPlant® is tested to reduce the long-term complications of aneurysmal subarachnoid haemorrhage (aSAH).

Timeline

Start

2020-04-05

Primary completion

2022-05-12

Completion

2023-01-23

Publications

• Wessels L, Wolf S, Adage T, Breitenbach J, Thome C, Kerschbaumer J, Bendszus M, Gmeiner M, Gruber A, Mielke D, Rohde V, Wostrack M, Meyer B, Gempt J, Bavinzski G, Hirschmann D, Vajkoczy P, Hecht N. Localized Nicardipine Release Implants for Prevention of Vasospasm After Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial. JAMA Neurol. 2024 Oct 1;81(10):1060-1065. doi: 10.1001/jamaneurol.2024.2564.

Drugs

Indications