Cisplatin-induced Hearing LossPhase 2PROHEARNCT06521190
ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin
A Phase 2 study testing ACOU085 (bimokalner) in people with Cisplatin-induced Hearing Loss, run by Acousia Therapeutics GmbH at 10 sites in Germany.
Trial summary
Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Cisplatin-induced Hearing Loss
- What is being tested?
- ACOU085 (bimokalner)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 10 sitesGermany
- Study dates
- 15 Dec 2023to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of testicular cancer with indication for a cis-Pt-containing chemotherapeutic regimen according to current treatment guidelines and site-specific tumor board recommendations
- Male adult patients at an age between 18 and 45 years
- Planned cis-Pt treatment with a cumulative dose of ≥300 mg/m2 which has to be administered in three chemotherapeutic cycles
- Normal or not clinically relevant otoscopic findings in both ears
- Normal hearing at both ears according to current WHO criteria for air-conduction 4PTA (0.5/1/2/4 kHz; 0 to 19 dB HL; average of audiometric thresholds at 0.5/1/2/4 kHz) at baseline
- Normal hearing at both ears according to ASHA criteria with a hearing threshold at any frequency (0.25 to 12 kHz) not exceeding 20 dB and a 4PTA (0.5/1/2/4 kHz) showing ≤15 dB HL at baseline
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- Normal distortion product oto-acoustic emissions (DPOAE) present in both ears at baseline
- Patient shows normal results at trial start (V1) concerning heart rate (50 to 90 bpm), blood pressure (according to commonly accepted ranges), ECG (no pathological findings), and laboratory parameters (ie, liver and renal function values not clinically significant)
- Male patients and their female partner(s) must agree to use 2 forms of contraception (one of which must be a barrier method) during 6 months after trial start (V1)
- Patient is cooperative, able to understand all aspects of the trial, and able to speak German comparable to native speakers as per the investigator's discretion
- Patient has signed an approved informed consent form indicating that he understands the purpose of and procedures required for the trial, will follow the trial-specific measures, and is willing to participate in the trial
Who cannot join
- Suspected or diagnosed genetic predisposition to hearing loss (incl. DFNA2 rel. to KCNQ4)
- History of middle ear pathology or surgery, otitis externa, chronic otitis media, or recent acute otitis media (within ≤3 months)
- History of otologic surgery (excluding myringotomy tubes or simple tympanoplasty)
- Meniere's disease or secondary endolymphatic hydrops, auto immune hearing loss, inner ear pathology, fluctuating hearing loss, perilymph fistula, cochlear baro-trauma, radiation-induced hearing loss, retro-cochlear lesion, severe tympanosclerosis, atrophic tympanic membrane
- Hearing loss of >45 dB averaged at 6 and 8 kHz in either ear
- Sudden hearing loss or conductive hearing loss >10 dB at two frequencies in either ear
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- Asymmetry in hearing thresholds between left and right ear ≥20 dB at any single frequency or ≥10 dB at any 3 consecutive frequencies ≤ 8 kHz
- Intake of any ototoxic drugs other than the intended cis-Pt-containing chemotherapeutic drug regimen prior to start of the trial and during the trial period
- Previous radiation exposure >35 Gray to complete or parts of the cochlea
- Severe concomitant diseases such as heart failure (NYHA II-IV), COPD, bronchial asthma, ongoing malignancies other than testicular cancer, auto-immune or chronic-inflammatory diseases, endocrinological diseases, advanced hepatic or renal failure, and primary complaint of tinnitus
- Planned consumption of medications, herbal preparations, and specific food ingredients to treat hearing problems and/or tinnitus during the trial period
- Hypersensitivity against any primary or secondary ingredient of IMP/Placebo medication
- Male patients with female partners who are pregnant or planning to become pregnant during 6 months after trial start (V1)
- Use of any other investigational medicinal product (IMP) within five times the half-life of that IMP/relevant metabolites or one month (whichever is longer) prior to screening and planned use during the trial or up to 30 days after trial completion
- Patient has any dependent relationship or employment status with respect to the trial site, the sponsor, the investigator, or any supervisor
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites, 10 recruiting
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Dresden University
Dresden
Marie-Luise Polk, Dr.
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Essen University
Essen
Diana Ahrweiler-Harbeck, Prof. Dr.
- Recruiting
Department of Otolaryngology - Head and Neck Surgery, Hamburg University
Hamburg
Mark Praetorius, Prof. Dr.
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Jena University
Jena
Orlando Guntinas-Lichius, Prof. Dr.
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Mannheim University
Mannheim
Angela Schell, Prof. Dr.
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Marburg University
Marburg
Wieland Behr, Dr.
- Recruiting
Dept. of Hematology and Oncology, Rotkreuzklinikum Munich
Munich
Marcus Hentrich, Prof. Dr.
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Munich Technical University
Munich
Markus Wirth, PD Dr.
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Tuebingen University
Tübingen, Baden-Wurttemberg, 72076
Sven Becker, PD Dr.
- Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Wuerzburg University
Würzburg
Till Meyer, PD Dr.
About this study
Official title: Phase IIa Randomized, Double-blind, and Placebo-controlled Multicenter Split Body Trial of Repeated Doses of ACOU085 for the Prevention of Hearing Loss in Testicular Cancer Patients Receiving Cisplatin
Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations. The trial is designed to show efficacy, safety, and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles. The intra-individual control will be done by placebo injection into the respective contralateral middle ear.
- Conditions
- Cisplatin-induced Hearing Loss
- Being tested
- ACOU085 (bimokalner), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACOU085 (bimokalner)Drug
Transtympanic injection
PlaceboDrug
Transtympanic injection
| Study group | Role | What they receive |
|---|---|---|
| Active ear | Active comparator | An ACOU085 retard formulation is transtympanically injected into the round window niche of the middle ear. Receives: Drug: ACOU085 (bimokalner) |
| Placebo ear | Placebo comparator | A matching placebo retard formulation is transtympanically injected into the round window niche of the contralateral middle ear. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTA air
Proportion of patients showing a difference of ≥10 dB between the ears in at least two frequencies for air conduction in PTA focused on high (4, 6, 8 kHz) and extended high frequencies (10, 12, 14, 16 kHz) between baseline (V1; prior to first initiation of cis-Pt-containing chemotherapy) and end of chemotherapeutic cycle 3 (V4)
Measured: Visit 4 at 9 weeks
Secondary outcomes (4)
Distortion Product Otoacoustic Emissions (DPOAE)
Intraindividual differences between the ears at Visits 2-5
Measured: 150 days
PTA bone
Intraindividual differences between the ears at Visits 2-5
Measured: 150 days
Oldenburger Test (speech understanding)
Intraindividual differences between the ears at Visits 2-5
Measured: 150 days
Freiburger Test
Intraindividual differences between the ears at Visits 2-5
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start15 Dec 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin-induced Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, and placebo-controlled multicenter split body trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acousia Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sven Becker, PD Dr., Principal investigator, Dept. of Otolaryngology - Head and Neck Surgery, Tübingen University, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521190
- Sponsor's protocol ID
- EUCT 2023-503696-15-00
- Acronym
- PROHEAR
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Randomized, Double-blind, and Placebo-controlled Multicenter Split Body Trial of Repeated Doses of ACOU085 for the Prevention of Hearing Loss in Testicular Cancer Patients Receiving Cisplatin
- ClinicalTrials.gov ID
- NCT06521190
- Acronym / sponsor ID
- PROHEAR / EUCT 2023-503696-15-00
- Conditions
- Cisplatin-induced Hearing Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Acousia Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations. The trial is designed to show efficacy, safety, and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles. The intra-individual control will be done by placebo injection into the respective contralateral middle ear.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, and placebo-controlled multicenter split body trial
| Arm | Type | Receives |
|---|---|---|
| Active ear | Active comparator | Drug: ACOU085 (bimokalner)An ACOU085 retard formulation is transtympanically injected into the round window niche of the middle ear. |
| Placebo ear | Placebo comparator | Drug: PlaceboA matching placebo retard formulation is transtympanically injected into the round window niche of the contralateral middle ear. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Confirmed diagnosis of testicular cancer with indication for a cis-Pt-containing chemotherapeutic regimen according to current treatment guidelines and site-specific tumor board recommendations
- Male adult patients at an age between 18 and 45 years
- Planned cis-Pt treatment with a cumulative dose of ≥300 mg/m2 which has to be administered in three chemotherapeutic cycles
- Normal or not clinically relevant otoscopic findings in both ears
- Normal hearing at both ears according to current WHO criteria for air-conduction 4PTA (0.5/1/2/4 kHz; 0 to 19 dB HL; average of audiometric thresholds at 0.5/1/2/4 kHz) at baseline
Key exclusion criteria (15 listed)
- Suspected or diagnosed genetic predisposition to hearing loss (incl. DFNA2 rel. to KCNQ4)
- History of middle ear pathology or surgery, otitis externa, chronic otitis media, or recent acute otitis media (within ≤3 months)
- History of otologic surgery (excluding myringotomy tubes or simple tympanoplasty)
- Meniere's disease or secondary endolymphatic hydrops, auto immune hearing loss, inner ear pathology, fluctuating hearing loss, perilymph fistula, cochlear baro-trauma, radiation-induced hearing loss, retro-cochlear lesion, severe tympanosclerosis, atrophic tympanic membrane
- Hearing loss of >45 dB averaged at 6 and 8 kHz in either ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACOU085 (bimokalner)Transtympanic injection | Drug | Active ear |
| PlaceboTranstympanic injection | Drug | Placebo ear |
Primary outcome
PTA air
Time frame: Visit 4 at 9 weeks
Proportion of patients showing a difference of ≥10 dB between the ears in at least two frequencies for air conduction in PTA focused on high (4, 6, 8 kHz) and extended high frequencies (10, 12, 14, 16 kHz) between baseline (V1; prior to first initiation of cis-Pt-containing chemotherapy) and end of chemotherapeutic cycle 3 (V4)
4 secondary outcomes
Distortion Product Otoacoustic Emissions (DPOAE)
Time frame: 150 days
PTA bone
Time frame: 150 days
Oldenburger Test (speech understanding)
Time frame: 150 days
Freiburger Test
Time frame: 150 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Cisplatin-induced Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
RecruitingPhase 2
Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial
Cisplatin-induced Ototoxicity, Sensorineural Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Becker, PD Dr. principal investigator
Dept. of Otolaryngology - Head and Neck Surgery, Tübingen University, Germany
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACOU085 (bimokalner) in people with Cisplatin-induced Hearing Loss, run by Acousia Therapeutics GmbH at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim P Boelke, MD (+491705670279, boelke@acousia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTA air (time frame: Visit 4 at 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.