Abstract | OBJECTIVE: STUDY DESIGN: Prospective, double-blind, randomized, placebo-controlled study with follow-up visits on Days 3, 7, 30, and 90. SETTING: Twenty-five European sites (academic tertiary referral centers, private ENT practices). PATIENTS: INTERVENTIONS: MAIN OUTCOME MEASURES: Efficacy was assessed by absolute hearing improvement (primary end point, Day 7), percentage hearing improvement, complete hearing recovery, speech discrimination improvement, and complete tinnitus remission. Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events. RESULTS: The study failed to demonstrate a treatment benefit for the entire study population because mild-to-moderate ASNHL cases showed unexpectedly strong spontaneous recovery. In severe-to-profound ASNHL patients (threshold ≥60 dB), AM-111 0.4 mg/ml showed statistically significant, clinically relevant, and persistent improvements in hearing and speech discrimination and higher tinnitus remission compared with placebo. The study drug and the intratympanic injections were well tolerated. CONCLUSION: The study established proof of concept for AM-111 in the treatment of severe-to-profound ASNHL. Control for spontaneous hearing recovery is essential for ASNHL studies.
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Authors | Markus Suckfuell, Grazyna Lisowska, Wojciech Domka, Anna Kabacinska, Krzysztof Morawski, Robert Bodlaj, Petr Klimak, Rom Kostrica, Thomas Meyer |
Journal | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
(Otol Neurotol)
Vol. 35
Issue 8
Pg. 1317-26
(Sep 2014)
ISSN: 1537-4505 [Electronic] United States |
PMID | 24979398
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Neuroprotective Agents
- Peptides
- D-JNKI-1
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Topics |
- Adolescent
- Adult
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Hearing Loss, Sensorineural
(drug therapy)
- Hearing Loss, Sudden
(drug therapy)
- Humans
- Male
- Middle Aged
- Neuroprotective Agents
(administration & dosage, adverse effects)
- Peptides
(administration & dosage, adverse effects)
- Prospective Studies
- Tinnitus
(drug therapy)
- Treatment Outcome
- Tympanic Membrane
(drug effects)
- Young Adult
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