Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial
Organizational Data
- DRKS-ID:
- DRKS00019107
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-05-08
- Last update in DRKS:
- 2024-02-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
AkNiPro2
URL of the study
No Entry
Brief summary in lay language
Adults with Akustikusneurinoma (Vestibularisschwannoma) with indication for surgery can participate in this trial.
Brief summary in scientific language
Adult patients with a vestibular schwannoma with indication for surgery can participate. The deterioration in hearing function or deafness that is often associated with the surgery will be evaluated. Previous studies have shown that prophylactic administration of the calcium antagonist nimodipine could have a neuroprotective effect. The aim of the study is to investigate whether the prophylactic administration of nimodipine has a neuroprotective effect and whether the hearing function can be maintained more frequently. For this purpose, patients are randomly randomized into the two study arms. The treatment group receives up to 2 mg / h nimodipine as an infusion from the day before the surgery up to 5 days postoperatively. The hearing function is examined before surgery, shortly after surgery and 3-6 months after surgery.
Health condition or problem studied
- Free text:
- vestibular shwannoma with indicaton for surgery
- ICD10:
- D33.3 - Cranial nerves
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- adult patients with vestibular schwannoma who are able to consent and who are indicated for surgery as standard therapy. In addition to standard therapy, treatment with nimodipine (Nimotop (R) S, Bayer Vital GmbH) Treatment schedule: Standard pre- and post-treatment for surgery From the day before the surgery up to 5 days postoperatively, infusion with nimodipine. Initial dose escalation from 1mg / h to 2mg / h. Maximum dose, depending on tolerance, from 0.5 mg / h to 2 mg / h.
- Arm 2:
- adult patients with vestibular schwannoma who are able to consent and who are indicated for surgery as standard therapy. Treatment schedule: Standard pre- and post-treatment for surgery
Endpoints
- Primary outcome:
- Postoperative cochlear nerve function measured before discharge according to GR scale 1-3 versus GR 4-5 (binary)
- Secondary outcome:
- 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); change in PTA and WRSmax; GR-scores and AAOHNS-scores; late deterioration of cochlear nerve function of at least one grade according to the GR scale compared with its preoperative function (binary); intraoperative 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; anatomical preservation of the cochlear nerve and preservation of wave V (BAEP); adverse events including intra and postoperative symptomatic hypotension
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- III
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Charite, Klinik für Neurochirurgie Berlin
- University medical center Neurochirurgische Klinik Göttingen
- University medical center Klinik für Neurochirurgie Münster
- University medical center Neurochirurgische Klinik und Poliklinik Würzburg
- Medical center Helios Klinik Erfurt, Neurochirurgie Erfurt
- University medical center Klinik für Neurochirurgie Freiburg
- University medical center Klinik und Poliklinik für Neurochirurgie Halle Saale
- University medical center Klinik für Neurochirurgie Tübingen
Recruitment period and number of participants
- Planned study start date:
- 2020-12-01
- Actual study start date:
- 2021-01-13
- Planned study completion date:
- 2026-03-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 336
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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)
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Halle Saale, Klinik und Poliklinik für Neurochirurgieapl. Prof. Christian SchellerErnst-Grube-Straße 4006120 Halle SaaleGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Halle Saale, Klinik und Poliklinik für Neurochirurgieapl. Prof. Christian SchellerErnst-Grube-Straße 4006120 Halle SaaleGermany
- Telephone:
- 0345 557 1399
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-halle.de
Contact for Public Queries
- Address:
- Universitätsklinikum Halle Saale, Klinik und Poliklinik für NeurochirurgieP. HänelErnst-Grube-Straße 4006120 Halle SaaleGermany
- Telephone:
- 0345 557 1472
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-halle.de
Principal Investigator
- Address:
- Universitätsklinikum Halle Saale, Klinik und Poliklinik für Neurochirurgieapl. Prof. Christian SchellerErnst-Grube-Straße 4006120 Halle SaaleGermany
- Telephone:
- 0345 557 1399
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-halle.de
Other contact for public queries
- Address:
- Koordinierungszentrum für Klinische Studien HalleAlexander LaschKiefernweg 3406120 Halle (Saale)Germany
- Telephone:
- +49 345 5574949
- Fax:
- +49 345 5575210
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kks-halle.de/cms5/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Martin-Luther-Universität Halle-WittenbergMagdeburger Str. 1206112 Halle (Saale)Germany
- Telephone:
- +49-345-5574476
- Fax:
- +49-345-5574477
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-01-22
- Ethics committee number:
- 2020-011
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-04-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- 2019-002317-19
- Other secondary IDs:
- SCHE 1984/2-1 - Deutsche Forschungsgemeinschaft
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Trials . 2021 Jul 22;22(1):475. doi: 10.1186/s13063-021-05417-z.
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00000328 - Vorgängerstudie
Publication of study results
- Planned publication:
- 08/2026
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry