2024-518182-10-00已完成3 期
Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial (AkNiPro2)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 8
- 主要终点
- Postoperative cochlear nerve function measured before discharge according to GR scale 1-3 versus GR 4-5 (binary)
研究概览
简要总结
To assess the efficacy and safety of prophylactic nimodipine treatment on hearing preservation after VS surgery in comparison to standard care only.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Postoperative cochlear nerve function measured before discharge according to GR scale 1-3 versus GR 4-5 (binary)
Postoperative cochlear nerve function measured before discharge according to GR scale 1-3 versus GR 4-5 (binary)
次要结局
- Anatomical preservation of the cochlear nerve and preservation of wave V (BAEP)
- Late postoperative cochlear nerve function measured at follow up three to six months after surgery (end of study) according to GR scale 1-3 versus GR 4-5 (binary)
- Postoperative deterioration of cochlear nerve function of at least one grade according to the GR scale compared with its preoperative function (binary)
- Late postoperative deterioration of cochlear nerve function of at least one grade according to the GR scale compared with its preoperative function measured at follow up three to six months after surgery (end of study) (binary)
- Change of pure-tone thresholds (PTA) and speech discrimination score (WRSmax)
- Comparison between GR-scores and AAOHNS-scores
- Intraoperative deterioration of BAEP mean values (amplitudes and latencies)
- Subjective quality of life / psychosocial impairment assessed by patient’s questionnaires (HHIE, SF-12, PANQOL) before surgery and at follow up three to six months
- Data on the safety and side effects of the medication will be obtained. For this purpose, adverse events are recorded descriptively in both groups and evaluated. Particular attention will be paid to intra and postoperative symptomatic hypotension.
研究者
Prof. Christian Scheller
Scientific
Martin-Luther-Universitaet Halle-Wittenberg
研究点 (8)
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