A study to investigate the efficacy of prophylactic nimodipine treatment on hearing preservation after vestibularis schwannoma surgery

Phase 1

• Conditions: Vestibular schwannomas with indication for surgery; MedDRA version: 20.0Level: LLTClassification code 10048925Term: Acoustic schwannomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-002317-19-DE
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-23
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

- Vestibular schwannomas (Koos I-IV) with indication for surgery
- Age: 18 years and older
- Preoperative pure tone audiometry (not older than 3 months prior to surgery), hearing function according to Gardner-Robertson scale (GR) 1-3
- Preoperative MRI (not older than 6 months prior to surgery)
- Written 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
- Ability to understand and give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 286
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Hearing function GR 4-5.
- conductive hearing loss at affected side
- 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
- Historx 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.
- Unstable angina pectoris and/or Myocardial infarction during the last four weeks before start of treatment
- Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
- Participation in another interventional trial simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed)
sever, uncontrolled, symptomatic hypotension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified