Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial (AkNiPro2)

This study is looking into whether a medication called nimodipine can help protect hearing in people who are having surgery for a non-cancerous growth near the brain, sometimes called an acoustic neuroma or vestibular schwannoma. These growths can affect hearing, and surgery, while often necessary, can sometimes further impact it. The main goal is to see if giving nimodipine helps keep hearing from getting worse shortly after the operation. Researchers will also check hearing over several months, assess overall quality of life, and monitor for any side effects from the medication. This trial aims to find better ways to preserve hearing for patients undergoing this type of surgery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Martin-Luther-Universitaet Halle-Wittenberg

Enrolment target

336

Start

30 Oct 2024

Acoustic schwannoma

What is this study about?

Imagine you have a small, typically non-cancerous growth near your brain that can affect your hearing and balance. Doctors call this a vestibular schwannoma, but it's also known as an acoustic neuroma. When surgery is needed to remove this growth, there's a risk that your hearing might get worse afterwards, even if the surgery goes well. This study is looking into whether a specific medication, called nimodipine, given around the time of surgery, can help protect your hearing.

The main aim of this research is to see if nimodipine can prevent a significant loss of hearing shortly after your operation. To do this, doctors will carefully check your hearing before you leave the hospital. They will also keep an eye on your hearing for several months after surgery and look at your overall quality of life to understand the bigger picture of your recovery. They want to find out if this drug can make a real difference for people undergoing this type of surgery.

This important study is a 'Phase III' trial, meaning it's one of the final steps in testing a new treatment before it might become widely available. The information gathered from this study will help doctors understand if nimodipine is a safe and effective way to help preserve hearing for patients undergoing vestibular schwannoma surgery. It's about finding the best possible outcomes for people facing this condition.

Key takeaways

This study is testing a drug to help protect hearing after surgery for a non-cancerous growth near the brain (vestibular schwannoma).
The main aim is to see if the drug nimodipine can prevent hearing loss shortly after surgery.
Your hearing will be tested several times, and you'll complete questionnaires about your quality of life.
The study will last about three to six months after your surgery.
Both men and women aged 18 and over can potentially take part.
Researchers will closely monitor for any side effects of the medication.

Who may be eligible?

To be part of this study, you need to be at least 18 years old – there's no upper age limit. Both men and women can take part. The study is specifically for people who are about to have surgery for a vestibular schwannoma, which is sometimes called an acoustic neuroma.

There might be other reasons why someone can't join the study, even if they meet these basic criteria. For example, if you have certain other health conditions or are taking particular medications, it might not be safe for you to take part. The study team will review your full medical history carefully.

Your doctors will carefully check if this study is suitable for you. They will consider your specific health situation to make sure joining is safe and appropriate, and that the study can get clear results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or older?
Are you scheduled for surgery for a vestibular schwannoma (acoustic neuroma)?
Are you able to attend follow-up appointments for approximately 3-6 months after surgery?
Do you understand that you will be monitored closely for medication side effects?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the study medication, nimodipine, which is given as an infusion (into a vein). This would happen around the time of your surgery. You would have your hearing carefully tested before your operation, before you leave the hospital, and again at a follow-up visit about three to six months after your surgery. These hearing tests help doctors understand if the medication is protecting your hearing.

Apart from hearing tests, you would also be asked to fill out some questionnaires about your quality of life. These would be done before your surgery and again at your follow-up appointment. Throughout your time in the study, doctors and nurses would carefully monitor you for any side effects from the medication, especially changes in your blood pressure. The total duration of your participation in the study would be until your follow-up appointment, about three to six months after your surgery.

Potential risks and benefits

Potential benefits of taking part could include the opportunity to receive a treatment that might help protect your hearing after surgery for a vestibular schwannoma, possibly leading to a better recovery for your hearing. However, there's no guarantee the treatment will work for everyone, or that you'll directly benefit. As with any medication, there are potential risks and side effects, and the study team will carefully monitor you for these. One specific side effect they will watch for is changes in blood pressure. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a vestibular schwannoma?

It's a non-cancerous growth that develops on the nerve leading from your inner ear to your brain. It can affect hearing and balance.

What is nimodipine?

It's a medication that can help widen blood vessels. In this study, we're seeing if it can help protect tiny blood vessels in the ear during surgery.

Will my hearing definitely be protected?

We can't guarantee your hearing will be protected. This study is designed to find out if nimodipine can improve the chances of preserving hearing.

How long will I be in the study?

You'll be in the study until your follow-up visit, which is typically three to six months after your surgery.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.