ACEMg for Hearing Loss and Tinnitus

(OTISRWD Trial)

Recruiting at 1 trial location

Overseen By Richard A Detweiler, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Keep Hearing, Inc.

Disqualifiers: No tinnitus, No hearing loss, Previous ACEMg use

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

ACEMg (Soundbites) is a neuroprotectant dietary supplement designed to block the initiating biological events in the inner ear leading to sensorineural hearing loss, SNHL, which accounts for more than 90% of all hearing loss. SNHL is so common it is called hearing loss. There is no cure for SNHL. The 24-week OTIS Study aims to validate findings from the previous two-year real-world study demonstrating ACEMg (Soundbites) preserved or improved auditory function (hearing) for 75.3% of participants who used it daily, with most improvement occurring within six months. Additionally, the study aims to assess the potential of ACEMg to relieve tinnitus symptoms in people with tinnitus. SNHL and tinnitus are related, but tinnitus relief was not measured in the previous two-year study. The OTIS study aims to answer two questions. First, does the real-world data demonstrate that hearing loss is stabilized or improved at the end of the test among participants with sensorineural hearing loss (SNHL or inner ear hearing loss) at the beginning? Second, do participants who self-report tinnitus symptoms at the start of their test report reduced symptoms at the end? Participants must be eighteen years of age and older and self-report hearing loss and/or tinnitus. The study is conducted at home using a smartphone app and a web-based assessment and data reporting tool developed for this study. The study starts with a baseline hearing assessment. Participants with tinnitus complete a baseline tinnitus survey. Then, each participant takes ACEMg softgel capsules daily, repeating the hearing assessment and the tinnitus survey after about 12 and 24 weeks. Assessment scores at the beginning of the study will be compared with scores at the end. Participation in the study is free.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the study coordinators or your doctor for guidance.

What data supports the idea that ACEMg for Hearing Loss and Tinnitus is an effective treatment?

The available research shows that tinnitus maskers, which are similar to ACEMg, are often more effective than hearing aids in managing tinnitus. This suggests that ACEMg could be effective as well. However, there is no specific data provided on ACEMg itself in the research articles. ^{1 2 3 4 5}

What safety data exists for ACEMg or Soundbites for hearing loss and tinnitus?

The provided research does not contain specific safety data for ACEMg or Soundbites related to hearing loss and tinnitus. The studies mentioned focus on other drugs and conditions, such as galcanezumab for migraines and celecoxib for pain management. Therefore, no relevant safety data for ACEMg or Soundbites is available in the provided research. ^{6 7 8 9 10}

Is ACEMg a promising treatment for hearing loss and tinnitus?

The information provided does not mention ACEMg or Soundbites, so we cannot determine if it is a promising treatment for hearing loss and tinnitus based on the given research articles. ^{1 11 12 13 14}

Research Team

Barry Seifer, MFA

Principal Investigator

Keep Hearing, Inc. 501c3

Eligibility Criteria

This trial is for adults with sensorineural hearing loss (SNHL) or tinnitus. Participants will take ACEMg softgel capsules daily and must be able to complete baseline assessments, as well as follow-up evaluations at approximately 12 and 24 weeks.

Inclusion Criteria

I have reported experiencing ringing in my ears.

Hearing loss assessed at the baseline test

Exclusion Criteria

I have used ACEMg (Soundbites) before.

No hearing loss assessed at the baseline test

I do not have tinnitus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a baseline hearing assessment and, if applicable, a tinnitus survey

1 week

1 visit (virtual)

Treatment

Participants take ACEMg softgel capsules daily and repeat hearing assessments and tinnitus surveys at 12 and 24 weeks

24 weeks

2 visits (virtual)

Follow-up

Participants' data is analyzed and shared with them after the 24-week study period

4 weeks

Treatment Details

Interventions

• ACEMg

Trial Overview The study tests whether ACEMg (Soundbites) can preserve or improve hearing in individuals with SNHL and if it can reduce tinnitus symptoms. It's a secondary analysis of real-world data from a previous two-year study, now focusing on results within six months.

Participant Groups

Group I: At-home Experimental Treatment 1 Intervention

Subjective auditory function assessments with the hearWHO app. Tinnitus survey. Participants take ACEMg softgel capsules daily, self-administered orally.

ACEMg is already approved in United States for the following indications:

Approved in United States as Soundbites for:

• Sensorineural hearing loss (SNHL)
• Tinnitus relief

Who Is Running the Clinical Trial?

Keep Hearing, Inc.

Lead Sponsor

Trials

1

Recruited

200+

Findings from Research

In a study involving 472 patients, tinnitus maskers were found to be more effective than hearing aids for managing tinnitus, although hearing aids are often the first choice for patients with significant hearing loss.

The study highlighted that thorough investigation and counseling significantly benefit patients, and there is no evidence that tinnitus masking negatively affects hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of tinnitus maskers. Hazell, JW., Wood, SM., Cooper, HR., et al.[2019]

A 3-day continuing education workshop on tinnitus management significantly improved audiologists' knowledge and confidence, with participants rating the workshop's usefulness very high both immediately after (mean 4.8) and three months later (mean 4.2).

Participants reported implementing changes in their practice based on the workshop content, indicating that the training effectively translated into practical application, although ongoing support was identified as necessary for continued improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of a Continuing Education Workshop for Audiologists on the Assessment and Management of Tinnitus. Searchfield, GD., Fok, C., Donaldson, T., et al.[2021]

In a study of 470 patients using the Neuromonics Tinnitus Treatment, 92% of the most suitable patients (tier 1) experienced a significant reduction in tinnitus disturbance, with an average improvement of 72%.

The effectiveness of the treatment varied by patient suitability, with lower success rates and higher discontinuance rates in less suitable categories, indicating that patient selection is crucial for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: clinical outcomes in general private practice. Hanley, PJ., Davis, PB., Paki, B., et al.[2022]

Approximately 10% of adults experience clinically significant tinnitus, with 1% suffering severe impacts on their quality of life, highlighting a critical need for effective treatments.

Recent advancements in understanding tinnitus mechanisms, animal models, and clinical trial methods have led to increased pharmaceutical interest, with several new compounds targeting tinnitus currently in development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging pharmacotherapy of tinnitus. Langguth, B., Elgoyhen, AB.[2011]

In a study of 133 tinnitus patients, those whose tinnitus frequencies were related to Distortion Product Otoacoustic Emissions (DPOAEs) showed a significantly higher treatment efficacy rate of 75.3% compared to 36.7% in those without this relationship after 14 days of drug therapy.

The results suggest that personalized drug therapy, including injections of Lipo PGE1 and vitamins B1 and B12, can be particularly effective for patients with acute tinnitus linked to specific auditory characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A study on relationship between distortion product otoacoustic emissions and therapeutic effects in tinnitus]. Zhang, J., Zhou, H., Xu, Y., et al.[2009]

In a Phase 2b study involving 410 patients with episodic migraine, galcanezumab was generally well-tolerated, with most treatment-emergent adverse events being mild to moderate, although some serious events were reported.

Injection-site reactions were more common with galcanezumab (13.9%) compared to placebo (5.8%), and the study supports further investigation in larger Phase 3 trials due to its safety profile and potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study. Oakes, TMM., Skljarevski, V., Zhang, Q., et al.[2022]

A systematic analysis of drug bioactivities and adverse events (AEs) revealed that examining multiple protein targets can improve the detection of drugs associated with AEs, highlighting the complexity of predicting ADRs.

Out of 45 protein targets linked to AEs, 30 are already part of safety panels, while 15 new targets, including specific carbonic anhydrases, were identified, suggesting that expanding safety profiling could enhance drug safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Analysis of Protein Targets Associated with Adverse Events of Drugs from Clinical Trials and Postmarketing Reports. Smit, IA., Afzal, AM., Allen, CHG., et al.[2021]

The Global Trigger Tool (GTT) has been modified since its introduction in 2003 and is used to identify and characterize adverse events (AEs) in healthcare settings, with studies showing AE rates ranging from 7% to 40% in inpatient settings.

Methodological differences among studies, including the number of reviewers and inclusion of 'acts of omission,' significantly affect reported AE rates, suggesting that comparisons between institutions or studies should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of the Global Trigger Tool: a systematic review. Hibbert, PD., Molloy, CJ., Hooper, TD., et al.[2022]

In a review of 231 randomized placebo-controlled clinical trials, it was found that a staggering 96.8% of adverse events (AEs) reported in patients taking active drugs were nonspecific, meaning they were not directly related to the medication.

The study revealed strong correlations between AE rates in placebo and active-drug groups, indicating that many reported AEs may not be caused by the drug itself, which raises concerns about the reliability of clinical trial data in assessing drug tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. Mahr, A., Golmard, C., Pham, E., et al.[2022]

Celecoxib is associated with a slightly increased risk of certain adverse events, such as edema, hypertension, angioedema, and allergic reactions compared to placebo, but these risks are relatively small.

In contrast, celecoxib shows a lower risk of gastrointestinal issues like hemorrhage and ulceration compared to non-selective NSAIDs, suggesting it may be a safer option for patients concerned about GI side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. Essex, MN., Zhang, RY., Berger, MF., et al.[2022]

Currently, there are no FDA-approved drugs specifically for treating tinnitus, leading to the availability of many unproven over-the-counter remedies that may cause harm without providing real benefits.

Animal models have been essential in understanding tinnitus and testing potential treatments, highlighting the need for more research to identify effective pharmacological therapies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Drugs in Animal Models of Tinnitus. Zheng, Y., McTavish, J., Smith, PF.[2021]

AM-101, an NMDA receptor antagonist delivered via intratympanic injection, has shown significant and dose-dependent improvement in acute tinnitus caused by glutamate excitotoxicity, based on results from a phase II clinical trial involving patients with tinnitus from acoustic trauma or otitis media.

The optimal treatment regimen for AM-101 was found to be three injections over three consecutive days, which provided the best outcomes for tinnitus improvement compared to a single dose or a three-dose regimen over two weeks, indicating that repeated inhibition of NMDA receptors is effective while minimizing patient burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting appropriate dose regimens for AM-101 in the intratympanic treatment of acute inner ear tinnitus. Staecker, H., Maxwell, KS., Morris, JR., et al.[2015]

In a study involving 248 patients with persistent tinnitus, intratympanic AM-101 (0.81 mg/ml) showed significant improvements in tinnitus loudness, annoyance, sleep difficulties, and overall impact, particularly in those with tinnitus from noise trauma or acute otitis media.

Although the primary endpoint of minimum masking level did not show a treatment benefit, the study suggests that patient-reported outcomes may be more effective measures for evaluating tinnitus treatments than traditional psychoacoustic tests, and AM-101 was well tolerated with no significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of AM-101 in the treatment of acute inner ear tinnitus--a double-blind, randomized, placebo-controlled phase II study. van de Heyning, P., Muehlmeier, G., Cox, T., et al.[2022]

In a study involving 10 patients with tinnitus and cochlear lesions, three reported a subjective reduction in tinnitus after taking amino-oxyacetic acid, suggesting some potential efficacy of the drug for this condition.

Additionally, improvements in speech discrimination scores were observed in three patients during treatment with amino-oxyacetic acid, indicating possible benefits beyond just tinnitus relief, although the overall response was limited and varied among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amino-oxyacetic acid as a palliative in tinnitus. Reed, HT., Meltzer, J., Crews, P., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A clinical study of tinnitus maskers. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

An Evaluation of a Continuing Education Workshop for Audiologists on the Assessment and Management of Tinnitus. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: clinical outcomes in general private practice. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Emerging pharmacotherapy of tinnitus. [2011]

5. China pubmed.ncbi.nlm.nih.gov

[A study on relationship between distortion product otoacoustic emissions and therapeutic effects in tinnitus]. [2009]

6. England pubmed.ncbi.nlm.nih.gov

Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Systematic Analysis of Protein Targets Associated with Adverse Events of Drugs from Clinical Trials and Postmarketing Reports. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The application of the Global Trigger Tool: a systematic review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Drugs in Animal Models of Tinnitus. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Selecting appropriate dose regimens for AM-101 in the intratympanic treatment of acute inner ear tinnitus. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of AM-101 in the treatment of acute inner ear tinnitus--a double-blind, randomized, placebo-controlled phase II study. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Amino-oxyacetic acid as a palliative in tinnitus. [2019]