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Aneurysmal Subarachnoid HemorrhagePhase 2NCT04269408

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

A Phase 2 study testing Nicardipine in people with Aneurysmal Subarachnoid Hemorrhage, run by BIT Pharma GmbH at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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®. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Aneurysmal Subarachnoid Hemorrhage
What is being tested?
Nicardipine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
6 sitesin 2 countries
Study dates
5 Apr 2020to 23 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent obtained according to the Country regulation.
  • Male or female patients aged 18 to 75 years (inclusive).
  • World Federation of Neurological Surgeons (WFNS) grade III-IV.
  • Ruptured saccular aneurysm, confirmed by angiography.
  • Onset of aSAH clinical symptoms within the preceding 48 hours.
  • Treatment of aneurysm via surgical clip ligation within 72 hours of aSAH is achievable.
  • Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) at screening and must agree to use adequate birth control up to 12 weeks after implantation of the study drug. Female patients are considered to be not of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 2 years without a natural menstrual cycle. Male patients must agree to use adequate birth control up to 12 weeks after implantation of the study drug.

Who cannot join

  • SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm).
  • World Federation of Neurosurgery (WFNS) grade I, II and V patients.
  • Pregnant or Lactating Women.
  • Intraventricular or intracerebral blood, in the absence of subarachnoid blood.
  • Treatment of aneurysm via endovascular embolisation.
  • Presence of moderate or severe vasospasm on screening angiography.
Show all 12Show fewer
  • Any known or CT /MRI evidence of previous major cerebral damage
  • Evidence of a cerebral infarction with neurological deficit on pre-treatment CT/MRI.
  • History of malignant disease (except for non-melanoma skin cancer) within the previous 5 years or any history of malignant brain tumours or brain metastasis.
  • Patients who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomisation.
  • Patients with known allergy for Poly(D,L-lactide-co-glycolide) (PLGA) or nicardipine.
  • Major complication during aneurysm repair such as, but not limited to, massive intraoperative haemorrhage, brain swelling, or inability to secure the ruptured aneurysm.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Austria3 sites

  • Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie

    Innsbruck, 6020

  • Kepler Universitätsklinikum, Universitätsklinik für Neurochirurgie

    Linz, 4020

  • Medizinische Universität Wien, Universitätsklinik für Neurochirurgie

    Vienna, 1090

Other trials in Austria

Germany3 sites

  • Charité Universitätsmedizin Berlin, Klinik für Neurochirurgie mit Arbeitsbereich pädiatrische Neurochirurgie

    Berlin, 10117

  • Universitätsklinikum Göttingen, Neurochirurgische Klinik

    Göttingen, 37075

  • Klinikum Rechts der Isar, Neurochirurgische Klinik und Poliklinik

    Munich, 81675

Other trials in Germany

About this study

Official title: A Phase IIb: Randomised, Single-Blind, Safety, Tolerability, Efficacy and Pharmacokinetic Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping

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).

Read the detailed description

This is a safety, tolerability, efficacy and pharmacokinetic study of NicaPlant® in subarachnoid haemorrhage patients involving two treatment groups. Both treatment groups will receive standard of care and patients randomised to the investigational group will receive in addition NicaPlant® .

NicaPlant® is a nicardipine modified-release formulation. It is presented in the form of a rod-shaped implant with a 4 mg nicardipine load. Following aneurysm clip ligation, 10 NicaPlant® implants will be placed into the basal cisterns in direct contact with the exposed cerebral blood vessel walls.

Being tested
Nicardipine, Standard of care
Keywords
NicaPlant, Nicardipine
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NicardipineDrug

    Also called NicaPlant®

    10 NicaPlant® implants releasing 4 mg nicardipine each.

  • Standard of careOther

    Both arms receive the usual standard of care.

Study groups in NCT04269408
Study groupRoleWhat they receive
NicaPlant®Experimental10 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.
Receives: Drug: Nicardipine; Other: Standard of care
ControlOtherStandard of care for aneurysmal subarachnoid haemorrhage patients according to the treatment guidelines.
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of moderate to severe cerebral angiographic vasospasm assessed by digital subtraction angiography

    Fishers Exact test

    Measured: day 8 ± 1 after aneurysm rupture

  2. Safety by adverse event recording

    Descriptive summary

    Measured: trough study completion, an average of 2 years

Secondary outcomes (1)

  1. Incidence of new cerebral infarcts on computer tomography (CT) of the brain versus post-intervention CT scan

    Fishers exact test

    Measured: up to day 14 ± 1 after aneurysm rupture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start5 Apr 2020
  3. Primary completion12 May 2022
  4. Study completion23 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04269408
Sponsor's protocol ID
BIT-002
Other IDs
2017-005159-10, 2017
Status last verified
Jul 2023
First submitted
23 Jan 2020
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 39158893

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nicardipine in people with Aneurysmal Subarachnoid Hemorrhage, run by BIT Pharma GmbH at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of moderate to severe cerebral angiographic vasospasm assessed by digital subtraction angiography (time frame: day 8 ± 1 after aneurysm rupture). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04269408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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