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Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial (AkNiPro2)
EU CTIS ID: 2024-518182-10-00
What this study is testing
To assess the efficacy and safety of prophylactic nimodipine treatment on hearing preservation after VS surgery in comparison to standard care only.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female adults age ≥ 18 years
- Vestibular schwannomas (Koos I-IV) with indication for surgery
- Preoperative pure tone audiometry (not older than 3 months prior to surgery), hearing function according to Gardner-Robertson scale (GR) 1-3 (Air-conduction PTA<90 dB HL)
- Preoperative MRI (not older than 6 months prior to surgery)
- Written informed consent obtained according to international guidelines and local laws
- Ability to understand and give informed consent
You likely can't join if
- Hearing function GR 4-5 (Air-conduction PTA (0.5-3kHz) >=90 dB HL)
- Unstable angina pectoris and/or Myocardial infarction during the last four weeks before start of treatment
- Severe, uncontrolled, symptomatic hypotension at inclusion
- Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol as well as officially and/or legally accomodated persons
- Participation in another interventional trial simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed)
- Conductive hearing loss at affected side (mean air-bone gap (0.5, 1, 2, 3 kHz) >10 dB) if bone-conduction is measurable
See the full eligibility criteria
- Male and female adults age ≥ 18 years
- Vestibular schwannomas (Koos I-IV) with indication for surgery
- Preoperative pure tone audiometry (not older than 3 months prior to surgery), hearing function according to Gardner-Robertson scale (GR) 1-3 (Air-conduction PTA<90 dB HL)
- Preoperative MRI (not older than 6 months prior to surgery)
- Written informed consent obtained according to international guidelines and local laws
- Ability to understand and give informed consent
- Safe contraception measures for males and females. Procedures with a pearl index of less than 1% or abstinence apply as safe pregnancy prevention measures
- Hearing function GR 4-5 (Air-conduction PTA (0.5-3kHz) >=90 dB HL)
- Unstable angina pectoris and/or Myocardial infarction during the last four weeks before start of treatment
- Severe, uncontrolled, symptomatic hypotension at inclusion
- Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol as well as officially and/or legally accomodated persons
- Participation in another interventional trial simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed)
- Conductive hearing loss at affected side (mean air-bone gap (0.5, 1, 2, 3 kHz) >10 dB) if bone-conduction is measurable
- Previously irradiated or surgical treated VS
- Neurofibromatosis, other brain tumors, other reasons for inoperability
- Pregnancy and lactation period
- Known hypersensitivity to nimodipine or any of the excipients (ethanol, Macrogol, sodiumcitrate, citric acid) to be used for nimodipine infusion
- History of (reformed alcoholic or) persistent abuse of alcohol
- Known current kidney or liver insufficiency
- Any medical condition that in the opinion of the investigator would not permit participation in the clinical trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.