Page last updated: 2024-10-26

ebselen and Tinnitus

ebselen has been researched along with Tinnitus in 1 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.

Tinnitus: A nonspecific symptom of hearing disorder characterized by the sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Objective tinnitus refers to noises generated from within the ear or adjacent structures that can be heard by other individuals. The term subjective tinnitus is used when the sound is audible only to the affected individual. Tinnitus may occur as a manifestation of COCHLEAR DISEASES; VESTIBULOCOCHLEAR NERVE DISEASES; INTRACRANIAL HYPERTENSION; CRANIOCEREBRAL TRAUMA; and other conditions.

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's1 (100.00)2.80

Authors

AuthorsStudies
Kil, J1
Harruff, EE1
Longenecker, RJ1

Clinical Trials (3)

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
[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

1 review available for ebselen and Tinnitus

ArticleYear
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