Page last updated: 2024-10-26

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

ExcerptRelevanceReference
"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."2.66Mechanisms 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)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (33.33)29.6817
2010's0 (0.00)24.3611
2020's2 (66.67)2.80

Authors

AuthorsStudies
Wang, J1
Wang, P1
Dong, C1
Zhao, Y1
Zhou, J1
Yuan, C1
Zou, L1
Kil, J1
Harruff, EE1
Longenecker, RJ1
Yamasoba, T1
Pourbakht, A1
Sakamoto, T1
Suzuki, M1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 240 participants (Actual)Interventional2015-12-31Completed
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 3254 participants (Actual)Interventional2022-08-02Active, 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 2149 participants (Actual)Interventional2017-09-28Completed
Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift[NCT01444846]Phase 283 participants (Actual)Interventional2011-09-30Completed
[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

,,
InterventionParticipants (Count of Participants)
Total Number of Patients with Treatment Emergent Adverse Events (TEAE)Number of Patients with Mild TEAENumber of Patients with Moderate TEAENumber of Patients with Severe TEAE
200mg SPI-1005 Twice Daily (BID)201830
400mg SPI-1005 BID201872
Placebo191560

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

,
Interventionng/mL (Mean)
2 weeks4 weeks8 weeks
200mg SPI-1005 Twice Daily (BID)27.219.70
400mg SPI-1005 BID48.440.60

Efficacy of SPI-1005 on Hearing Loss

Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry (NCT03325790)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz)72572366Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz)72572367Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz)72572368Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz)72572366Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz)72572367Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz)72572368
NoYes
Placebo15
200mg SPI-1005 Twice Daily (BID)16
400mg SPI-1005 BID25
Placebo26
200mg SPI-1005 Twice Daily (BID)26
400mg SPI-1005 BID16
Placebo8
200mg SPI-1005 Twice Daily (BID)7
400mg SPI-1005 BID15
Placebo33
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

InterventionParticipants (Count of Participants)
WIN Score Improvement from Baseline >=10%72572368WIN Score Improvement from Baseline >=10%72572366WIN Score Improvement from Baseline >=10%72572367WIN Score Improvement from Baseline >=20%72572368WIN Score Improvement from Baseline >=20%72572366WIN Score Improvement from Baseline >=20%72572367WIN Score Improvement from Baseline >= 4 words72572366WIN Score Improvement from Baseline >= 4 words72572367WIN Score Improvement from Baseline >= 4 words72572368
YesNo
Placebo23
200mg SPI-1005 Twice Daily (BID)23
400mg SPI-1005 BID30
Placebo18
200mg SPI-1005 Twice Daily (BID)18
400mg SPI-1005 BID10
Placebo19
200mg SPI-1005 Twice Daily (BID)17
400mg SPI-1005 BID27
Placebo22
200mg SPI-1005 Twice Daily (BID)24
400mg SPI-1005 BID13
Placebo14
200mg SPI-1005 Twice Daily (BID)13
400mg SPI-1005 BID24
Placebo27
200mg SPI-1005 Twice Daily (BID)28
400mg SPI-1005 BID16

Reviews

2 reviews available for ebselen and Hearing Loss, Sensorineural

ArticleYear
Mechanisms of ebselen as a therapeutic and its pharmacology applications.
    Future medicinal chemistry, 2020, Volume: 12, Issue:23

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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.
    Hearing research, 2022, Volume: 413

    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

ArticleYear
Ebselen prevents noise-induced excitotoxicity and temporary threshold shift.
    Neuroscience letters, 2005, Jun-03, Volume: 380, Issue:3

    Topics: Animals; Auditory Threshold; Azoles; Cochlear Nerve; Dendrites; Disease Models, Animal; Evoked Poten

2005
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