NCT04801953

Nimodipine in Vestibular Schwanommas

Status unknown Phase 2 Last updated 19 October 2023

What this trial tests

Phase 2 trial testing NiMODipine Injectable Solution in Vestibular Schwannoma in 30 participants. Status unknown.

Timeline

4 May 2021

Primary endpoint
9 April 2024

9 April 2024

Quick facts

Lead sponsor	Medical University of Vienna
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	prevention
Enrollment	30
Start date	4 May 2021
Primary completion	9 April 2024
Estimated completion	9 April 2024
Sites	1 location across Austria

Drugs / interventions tested

• NiMODipine Injectable Solution — full drug profile →
• Placebo

Conditions studied

• Vestibular Schwannoma — all drugs for Vestibular Schwannoma →

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 90, any sex, with Vestibular Schwannoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Title:

Intraoperative application of nimodipine to the facial and cochlear nerves during vestibular schwannoma resection to avoid spasm-related postoperative facial paralysis and deafness - a prospective randomized study

Background:

In patients undergoing microsurgical resection of a vestibular schwannoma, the facial and vestibulocochlear nerves are at risk. Prior studies suggested positive effects of nimodipine for preservation of the nerve function in these patients. A prospective, randomized, placebo controlled double-blinded study will be conducted to evaluate the neuro-protective effect of locally administered nimodipine during resection of vestibular schwannomas.

Investigational drug:

active group: "Nimotop® 10mg - Infusionsflasche" placebo: "Natrium chloratum physiologicum 0,9% - Medica Infusionslösung"

Rationale for the study: Nimodipine is supposed to counteract the vasoconstriction of cerebral arteries caused by microsurgical manipulation and might thereby preserve facial and cochlear nerve function

Aims of the study: Evaluation of the effect of intraoperative local administration of nimodipine on the postoperative function of the facial and vestibulocochlear nerves after microsurgical resection of vestibular schwannomas

Study design: prospective, double-blinded, single-center, randomized phase III trial

Study population: Patients undergoing microsurgical resection of a vestibularis schwannoma with a maximum diameter of 10-25mm on MRI at the Department of Neurosurgery, Medical university of Vienna.

Number of Patients: 30

Methods: In 15 patients, nimodipine will be administered locally to the facial and vestibulocochlear nerves during resection of a vestibular schwannoma (= treatment group). In another 15 patients, a placebo (sodium chloride solution) will be administered. In both cases, a soaked gel foam pad will be used. The operating team and the patient will both be blinded during the procedure. Facial nerve function and hearing will be assessed prior and three months after surgery.

Outcome variables: Serviceable or non-serviceable hearing according to Gardner-Robertson hearing scale and House-Brackmann score for the assessment of facial nerve function

Statistical analysis: For the evaluation of the postoperative function of the vestibulocochlear nerve, the number of patients with postoperative serviceable hearing (Gardner-Robertson I-II) and postoperative non-serviceable hearing (Gardner-Robertson III-V) will be compared between both groups. For the evaluation of the facial nerve function, the number of patients with favorable postoperative outcome (House-Brackmann I-III) and non-favorable postoperative outcome (House-Brackmann IV-VI) will be compared. In both cases, fisher's exact test will be used.

Expected risks/inconveniences: Administration of nimodipine is associated with the following adverse effects: thrombocytopenia, allergic reactions, headache, tachycardia, hypotension, nausea (occasionally) and bradycardia, ileus, reversibly elevated liver enzymes (seldom)

Risk/benefit assessment: Expected adverse effects of local nimodipine administration are manageable and patients may profit from the use of nimodipine. No severe adverse events are expected.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vestibular schwannoma: genetic and epigenetic mechanisms, hearing loss, and emerging therapies.
   Otaner F, Himic V, Vargas LO, Abikenari M, et al · · 2026 · PMID 42143176 · DOI 10.1007/s11060-026-05621-4