Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Not recruitingAcoustic neuroma
Study on Nimodipine for Hearing Preservation in Patients Undergoing Acoustic Schwannoma Surgery
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a medication called nimodipine on preserving hearing after surgery for a condition known as vestibular schwannoma, which is also commonly referred to as an acoustic neuroma. This condition involves a non-cancerous growth on the nerve that connects the ear to the brain, which can affect hearing and balance. The treatment being tested is a solution for infusion, meaning it is administered directly into the bloodstream through a vein.
The purpose of the study is to evaluate how effective and safe nimodipine is in maintaining hearing ability after surgery compared to the standard care that patients usually receive. Participants in the study will be randomly assigned to receive either the nimodipine treatment or standard care, which may include a placebo. The study will monitor participants' hearing function before and after surgery, as well as several months later, to assess any changes or improvements.
Throughout the study, researchers will collect data on the participants' hearing levels, any changes in their ability to hear, and their overall quality of life. The study will also track any side effects or safety concerns related to the medication, with particular attention to any changes in blood pressure. The trial is expected to continue until March 2026, with participants being followed up for several months after their surgery to gather comprehensive results.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- Adults who are **18 years or older** can participate.
- Participants must have a condition called **vestibular schwannomas**, which is a type of growth in the ear area, and need surgery for it.
- Participants need to have a **hearing test** called pure tone audiometry done within 3 months before the surgery. Their hearing should be within a certain range according to a scale called the **Gardner-Robertson scale**.
- Participants should have had an **MRI scan** within 6 months before the surgery. An MRI is a type of scan that helps doctors see inside the body.
- Participants must provide **written informed consent**, which means they agree to join the study after understanding what it involves.
- Participants need to be able to **understand and give informed consent**, meaning they should understand the study details and agree to participate.
- Participants must use **safe contraception measures** if they are of childbearing potential. This means using reliable methods to prevent pregnancy.
Who cannot join the trial?
7 criteria
- Patients who are not diagnosed with acoustic schwannoma cannot participate. Acoustic schwannoma is a type of non-cancerous tumor that affects the nerve responsible for hearing and balance.
- Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 64 years old.
- Patients who are not able to undergo surgery for their condition cannot participate.
- Patients who have any medical condition that makes it unsafe for them to take the study medication, nimodipine, cannot participate. Nimodipine is a medication used to help protect the brain and nerves.
- Patients who are pregnant or breastfeeding cannot participate.
- Patients who are unable to give informed consent, meaning they cannot understand the study and agree to participate, cannot participate.
- Patients who are participating in another clinical trial at the same time cannot participate.
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Verified sites
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Martin-Luther-Universitaet Halle-Wittenberg
VerifiedHalle (Saale), GermanyMedical Center - University Of Freiburg
VerifiedFreiburg Im Breisgau, Germany
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Investigated drugs
Nimodipine is a medication being studied for its potential to help preserve hearing after surgery for vestibular schwannoma, a type of non-cancerous brain tumor. The trial is investigating whether taking nimodipine before surgery can protect hearing better than the standard care alone.
What is already known about the treatment
Nimodipine – Nimodipine is administered orally in tablet form or intravenously, depending on the specific medical needs. It is currently being studied in clinical trials for its potential to preserve hearing after surgery for vestibular schwannoma, a type of benign tumor affecting the nerve responsible for hearing and balance. The medication is classified as a calcium channel blocker, which works by relaxing and widening blood vessels, improving blood flow, and reducing the risk of damage to nerves during surgery. Nimodipine is well-documented in medical literature for its use in preventing brain damage caused by reduced blood flow, and its application in this trial aims to explore its benefits in ear-related surgeries.
Investigated diseases
Acoustic Schwannoma – Acoustic schwannoma, also known as vestibular schwannoma, is a non-cancerous tumor that develops on the eighth cranial nerve, which is responsible for balance and hearing. This tumor typically grows slowly and can lead to hearing loss, tinnitus (ringing in the ear), and balance issues as it enlarges. As the tumor progresses, it may exert pressure on nearby nerves and structures, potentially causing additional symptoms such as facial numbness or weakness. The growth of the tumor can vary, with some remaining small and others growing large enough to cause significant symptoms. The condition is often diagnosed in middle-aged adults and is not considered a rare disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518182-10-00Protocol codeKKSH155Estimated enrolment336 patientsSponsorMartin-Luther-Universitaet Halle-Wittenberg
sourced from the EU Clinical Trials Register and site verification
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