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

Sponsor
BIT Pharma GmbH
Study ID
NCT04269408
Phase
PHASE2
Status
Completed

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Nicardipine — DRUG
    10 NicaPlant® implants releasing 4 mg nicardipine each.
  • Standard of care — OTHER
    Both arms receive the usual standard of care.

Study Details

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).

Key Dates

Start date
Apr 5, 2020
Status verified
Jul 2023
Primary completion
May 12, 2022
Completion
Jan 23, 2023

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NicaPlant®
    10 NicaPlant® implants (total 40 mg nicardipine) will be placed after clip ligation into the basal cisterns in direct contact with the exposed cerebral blood vessel walls. In addition patients will receive standard of care for aneurysmal subarachnoid haemorrhage patients according to the treatment guidelines.
  • Other: Control
    Standard of care for aneurysmal subarachnoid haemorrhage patients according to the treatment guidelines.

Primary Outcome Measure

Incidence of moderate to severe cerebral angiographic vasospasm assessed by digital subtraction angiography [ Time Frame: day 8 ± 1 after aneurysm rupture ]

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