Prospective randomised multi-centre trial (Phase III) on the improvement of cochlear and facial nerve functions after vestibular schwannoma surgery by prophylactic vasoactive treatment.

Phase 3

• Conditions: MedDRA - LLT 10000522: Acoustic neurinoma; D33.3; Cranial nerves

• Registration Number: DRKS00000328
• Lead Sponsor: Martin-Luther-Universität Halle-WittenbergMedizinische Fakultät

Brief Summary

Intent-to-treat analysis showed no statistically significant effects of the treatment on either preservation of facial nerve function (35 [67.3%] of 52 [treatment group] compared with 34 [72.3%] of 47 [control group]) (p = 0.745) or hearing preservation (11 [23.4%] of 47 [treatment group] compared with 15 [31.2%] of 48 [control group]) (p = 0.530) 12 months after surgery. Since tumor sizes were significantly larger in the treatment group than in the control group, logistic regression analysis was required. The risk for deterioration of facial nerve function was adjusted nearly the same in both groups (OR 1.07 [95% CI 0.34-3.43], p = 0.91). In contrast, the risk for postoperative hearing loss was adjusted 2 times lower in the treatment group compared with the control group (OR 0.49 [95% CI 0.18-1.30], p = 0.15). Apart from dose-dependent hypotension (p < 0.001), no clinically relevant adverse reactions were observed.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-17
• Study Completion: 2013-02-26
• Results First Posted: 2015-08-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Age >= 18 years
- Male or female patients who are able to give informed consent
- Acoustic neuroma, indication for surgery
- Written informed consent

Exclusion Criteria

- Contraindication for the administration of study drug (nimodipine, hydroxyethylstarch)
- Concurrent treatment with other experimental drugs or
participation in another clinical trial with any investigational drug within 30 days prior to study screening
- History of critical interactions between nimodipine and other potentially nephrotoxic agents such as aminoglycosids, cephalosporids, furosemid
- Preoperative facial nerve function House-Brackmann grade VI
- Preliminary surgery of the acoustic neuroma
- Pregnancy and lactation
- Incompliance
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- Other reasons for inability to undergo surgery
- Neurofibrimatosis type 2

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Binary outcome value. Deterioration of facial nerve functions 12 month after surgery for at least 1 grade (House-Brackmann classification)

Secondary Outcome Measures

Name	Time	Method
Facial nerve functions once during the first 7 days postoperatively as well as 3, 6 and 12 month after surgery compared to the preoperative situation determined using the House-Brackmann classification. || Cochlear nerve functions once during the first 7 days postoperatively and 12 month after surgery determined using the following classifications<br>a)Committee on Hearing and Equilibrium guidelines for the evaluation of hearing preservation in acoustic neuroma (vestibular schwannoma)<br>b) Grading of hearing loss according Gardener and Robertson