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.
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 0 (0.00) | 24.3611 |
2020's | 1 (100.00) | 2.80 |
Authors | Studies |
---|---|
Kil, J | 1 |
Harruff, EE | 1 |
Longenecker, RJ | 1 |
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 | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"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 (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 |
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 |
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 |
1 review available for ebselen and Tinnitus
Article | Year |
---|---|
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 |