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

Phase 3

Recruiting

• Conditions: vestibular shwannoma with indicaton for surgery; D33.3; Cranial nerves

• Registration Number: DRKS00019107
• Lead Sponsor: niversitätsklinikum Halle Saale, Klinik und Poliklinik für Neurochirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

1.Male and female adults age = 18 years
2.Vestibular schwannomas (Koos I-IV) with indication for surgery
3.Preoperative pure-tone audiogram (not older than 3 months prior to surgery), hearing function according to Gardner-Robertson scale (GR) 1-3 (Air-conduction PTA (0.5-3kHz) <90 dB HL)
4.Preoperative MRI (not older than 6 months prior to surgery)
5.Written informed consent obtained according to international guidelines and local laws
6. Ability to understand and give informed consent.
7.Safe contraception measures for males and females. Procedures with a pearl index of less than 1% apply as safe pregnancy prevention measures.

Exclusion Criteria

1. Hearing function GR 4-5 (Air-conduction PTA (0.5-3kHz) >=90 dB HL)
2. conductive hearing loss at affected side (mean air-bone gap (0.5, 1, 2, 3 kHz) >10 dB) if
bone-conduction is measurable
3. Previously irradiated or surgical treated VS
4. Neurofibromatosis, other brain tumors, other reasons for inoperability
5. Pregnancy and lactation period
6. Known hypersensitivity to nimodipine or any of the excipients (ethanol, Macrogol, sodiumcitrate, citric acid) to be used for nimodipine infusion
7. History of (reformed alcoholics) or persistent abuse of alcohol
8. Known current kidney or liver insufficiency
9. Any medical condition that in the opinion of the investigator would not permit
participation in the clinical trial.
10. Unstable angina pectoris and/or Myocardial infarction during the last four weeks before
start of treatment
11. severe, uncontrolled, symptomatic hypotension at inclusion
12. 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
13. Participation in another interventional trial simultaneously and within the last 30 days
prior to inclusion (registries or observational studies allowed)

Study & Design

• Study Type: interventional
• Study Design: Not specified