Trial reportOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2014
Efficacy and safety of AM-101 in the treatment of acute inner ear tinnitus--a double-blind, randomized, placebo-controlled phase II study.
Trial report in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.
- Conservative management of functional middle ear disorders: a systematic review with narrative synthesis and conceptual clinical framework.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026Pooled it
- A randomized, double-blind, placebo-controlled phase 2 study of intratympanic OTO-313 in patients with moderate to severe subjective tinnitus.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023Trial
- Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2021Trial
- Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans.Scientific reports · 2017Trial
- Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2017Trial
- Trial
- Transdermal lidocaine as treatment for chronic subjective tinnitus: A pilot study.American journal of otolaryngologyTrial
- Unveiling the Role of Oxidative Stress in Cochlear Hair Cell Death: Prospective Phytochemical Therapeutics against Sensorineural Hearing Loss.International journal of molecular sciences · 2024Review
- Multidisciplinary Tinnitus Research: Challenges and Future Directions From the Perspective of Early Stage Researchers.Frontiers in aging neuroscience · 2021Review
- Corrigendum: Multidisciplinary Tinnitus Research: Challenges and Future Directions From the Perspective of Early Stage Researchers.Frontiers in aging neuroscience · 2021Article
- Pharmacotherapy of Tinnitus.Current topics in behavioral neurosciences · 2021Review
- Physiopathological Relevance of D-Serine in the Mammalian Cochlea.Frontiers in cellular neuroscience · 2021Article
- Objective Verification of Acute Tinnitus and Validation of Efficacy of Systemic Steroids in Rats.Journal of Korean medical science · 2020Article
- Auditory Neural Plasticity in Tinnitus Mechanisms and Management.Neural plasticity · 2020Review
- Local Drug Delivery for the Treatment of Neurotology Disorders.Frontiers in cellular neuroscience · 2019Review
- Excitation of the Auditory System as a Result of Non-invasive Extra-Cochlear Stimulation in Normal Subjects and Tinnitus Patients.Frontiers in neuroscience · 2018Article
- Assessment of the State of the Natural Antioxidant Barrier of a Body in Patients Complaining about the Presence of Tinnitus.Oxidative medicine and cellular longevity · 2018Article
- Management of Chronic Tinnitus and Insomnia with Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy - a Combined Approach.Frontiers in psychology · 2017Article
- Correlation between afferent rearrangements and behavioral deficits after local excitotoxic insult in the mammalian vestibule: a rat model of vertigo symptoms.Disease models & mechanisms · 2016Article
- Characteristics and Spontaneous Recovery of Tinnitus Related to Idiopathic Sudden Sensorineural Hearing Loss.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of intratympanic AM-101 in patients with persistent acute inner ear tinnitus after acute acoustic trauma, idiopathic sudden sensorineural hearing loss (ISSNHL), or acute otitis media. STUDY
designProspective, double-blind, randomized, placebo-controlled study with follow-up visits on Days 7, 30, and 90.
settingTwenty-eight European sites (academic tertiary referral centers and private ENT practices). PATIENTS: 248 patients aged 16 to 65 years.
interventionsThree intratympanic injections of AM-101 (0.27 or 0.81 mg/ml) or placebo over 3 consecutive days.
main outcome measuresEfficacy was assessed by changes in minimum masking level (MML; primary end point), loudness match, tinnitus loudness, tinnitus annoyance, and sleep difficulties on a 0 to 100 numerical rating scale, THI-12 questionnaire, and patient global impression of change. Safety was evaluated using the frequency of clinically relevant hearing deterioration and adverse events.
resultsThe study overall failed to demonstrate a treatment benefit based on the change in MML. However, AM-101 0.81 mg/ml showed statistically significantly better improvement for tinnitus loudness, annoyance, sleep difficulties, and tinnitus impact in patients with tinnitus after noise trauma or otitis media. The subgroup of ISSNHL-related tinnitus patients did not show conclusive results. The study drug and I.T. injections were well tolerated.
conclusionThe study established proof of concept for AM-101 in the treatment of tinnitus arising from cochlear glutamate excitotoxicity. Patient-reported outcomes seem to be more relevant and reliable efficacy measures for assessing treatment-related changes in tinnitus than psychoacoustic tests.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.