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

NCT04269408 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-07-12

No results posted yet for this study

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).

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

DRUG

Nicardipine

10 NicaPlant® implants releasing 4 mg nicardipine each.

OTHER

Standard of care

Both arms receive the usual standard of care.

Sponsors & Collaborators

  • NeuroScios GmbH

    collaborator UNKNOWN

  • Data Magik Limited

    collaborator UNKNOWN

  • Pharm-Analyt Labor GmbH

    collaborator UNKNOWN

  • BIT Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Claudius Thomé, Prof.Dr. · Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-05
Primary Completion
2022-05-12
Completion
2023-01-23

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04269408 on ClinicalTrials.gov