ebselen and Hearing Loss, Sensorineural
ebselen has been researched along with Hearing Loss, Sensorineural in 3 studies
ebselen : A benzoselenazole that is 1,2-benzoselenazol-3-one carrying an additional phenyl substituent at position 2. Acts as a mimic of glutathione peroxidase.
Hearing Loss, Sensorineural: Hearing loss resulting from damage to the COCHLEA and the sensorineural elements which lie internally beyond the oval and round windows. These elements include the AUDITORY NERVE and its connections in the BRAINSTEM.
Research Excerpts
Excerpt | Relevance | Reference |
---|---|---|
"Ebselen is a synthetic organoselenium radical scavenger compound that possesses glutathione peroxidase-like activity and its own unique bioactivity by reacting with thiols, hydroperoxides and peroxynitrites." | 2.66 | Mechanisms of ebselen as a therapeutic and its pharmacology applications. ( Dong, C; Wang, J; Wang, P; Yuan, C; Zhao, Y; Zhou, J; Zou, L, 2020) |
Research
Studies (3)
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (33.33) | 29.6817 |
2010's | 0 (0.00) | 24.3611 |
2020's | 2 (66.67) | 2.80 |
Authors
Authors | Studies |
---|---|
Wang, J | 1 |
Wang, P | 1 |
Dong, C | 1 |
Zhao, Y | 1 |
Zhou, J | 1 |
Yuan, C | 1 |
Zou, L | 1 |
Kil, J | 1 |
Harruff, EE | 1 |
Longenecker, RJ | 1 |
Yamasoba, T | 1 |
Pourbakht, A | 1 |
Sakamoto, T | 1 |
Suzuki, M | 1 |
Clinical Trials (4)
Trial Overview
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease[NCT02603081] | Phase 1/Phase 2 | 40 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005[NCT04677972] | Phase 3 | 254 participants (Actual) | Interventional | 2022-08-02 | Active, not recruiting | ||
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease[NCT03325790] | Phase 2 | 149 participants (Actual) | Interventional | 2017-09-28 | Completed | ||
Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift[NCT01444846] | Phase 2 | 83 participants (Actual) | Interventional | 2011-09-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAE)
"Number and severity of adverse events in patients treated with placebo versus SPI-1005.~Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting." (NCT03325790)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) | |||
---|---|---|---|---|
Total Number of Patients with Treatment Emergent Adverse Events (TEAE) | Number of Patients with Mild TEAE | Number of Patients with Moderate TEAE | Number of Patients with Severe TEAE | |
200mg SPI-1005 Twice Daily (BID) | 20 | 18 | 3 | 0 |
400mg SPI-1005 BID | 20 | 18 | 7 | 2 |
Placebo | 19 | 15 | 6 | 0 |
Trough Plasma Concentration of SPI-1005
Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals (NCT03325790)
Timeframe: 2 weeks, 4 weeks, 8 weeks
Intervention | ng/mL (Mean) | ||
---|---|---|---|
2 weeks | 4 weeks | 8 weeks | |
200mg SPI-1005 Twice Daily (BID) | 27.2 | 19.7 | 0 |
400mg SPI-1005 BID | 48.4 | 40.6 | 0 |
Efficacy of SPI-1005 on Hearing Loss
Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry (NCT03325790)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz)72572366 | Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz)72572367 | Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz)72572368 | Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz)72572366 | Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz)72572367 | Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz)72572368 | |||||||
No | Yes | |||||||||||
Placebo | 15 | |||||||||||
200mg SPI-1005 Twice Daily (BID) | 16 | |||||||||||
400mg SPI-1005 BID | 25 | |||||||||||
Placebo | 26 | |||||||||||
200mg SPI-1005 Twice Daily (BID) | 26 | |||||||||||
400mg SPI-1005 BID | 16 | |||||||||||
Placebo | 8 | |||||||||||
200mg SPI-1005 Twice Daily (BID) | 7 | |||||||||||
400mg SPI-1005 BID | 15 | |||||||||||
Placebo | 33 | |||||||||||
200mg SPI-1005 Twice Daily (BID) | 35 |
Efficacy of SPI-1005 on Word Recognition Score
Improvement in Words-in-Noise (WIN) test score from baseline. WIN test score, 0-35 words, in which a higher score means a better outcome. (NCT03325790)
Timeframe: 8 weeks
Intervention | Participants (Count of Participants) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
WIN Score Improvement from Baseline >=10%72572368 | WIN Score Improvement from Baseline >=10%72572366 | WIN Score Improvement from Baseline >=10%72572367 | WIN Score Improvement from Baseline >=20%72572368 | WIN Score Improvement from Baseline >=20%72572366 | WIN Score Improvement from Baseline >=20%72572367 | WIN Score Improvement from Baseline >= 4 words72572366 | WIN Score Improvement from Baseline >= 4 words72572367 | WIN Score Improvement from Baseline >= 4 words72572368 | ||||||||||
Yes | No | |||||||||||||||||
Placebo | 23 | |||||||||||||||||
200mg SPI-1005 Twice Daily (BID) | 23 | |||||||||||||||||
400mg SPI-1005 BID | 30 | |||||||||||||||||
Placebo | 18 | |||||||||||||||||
200mg SPI-1005 Twice Daily (BID) | 18 | |||||||||||||||||
400mg SPI-1005 BID | 10 | |||||||||||||||||
Placebo | 19 | |||||||||||||||||
200mg SPI-1005 Twice Daily (BID) | 17 | |||||||||||||||||
400mg SPI-1005 BID | 27 | |||||||||||||||||
Placebo | 22 | |||||||||||||||||
200mg SPI-1005 Twice Daily (BID) | 24 | |||||||||||||||||
400mg SPI-1005 BID | 13 | |||||||||||||||||
Placebo | 14 | |||||||||||||||||
200mg SPI-1005 Twice Daily (BID) | 13 | |||||||||||||||||
400mg SPI-1005 BID | 24 | |||||||||||||||||
Placebo | 27 | |||||||||||||||||
200mg SPI-1005 Twice Daily (BID) | 28 | |||||||||||||||||
400mg SPI-1005 BID | 16 |
Reviews
2 reviews available for ebselen and Hearing Loss, Sensorineural
Article | Year |
---|---|
Mechanisms of ebselen as a therapeutic and its pharmacology applications.
Topics: Animals; Azoles; Bipolar Disorder; Cardiovascular Diseases; Hearing Loss, Sensorineural; Humans; Imm | 2020 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Development of ebselen for the treatment of sensorineural hearing loss and tinnitus.
Topics: Animals; Audiometry, Pure-Tone; Hearing Loss, Noise-Induced; Hearing Loss, Sensorineural; Humans; Is | 2022 |
Other Studies
1 other study available for ebselen and Hearing Loss, Sensorineural
Article | Year |
---|---|
Ebselen prevents noise-induced excitotoxicity and temporary threshold shift.
Topics: Animals; Auditory Threshold; Azoles; Cochlear Nerve; Dendrites; Disease Models, Animal; Evoked Poten | 2005 |