5 completed, 1 active not recruiting, 1 recruiting, 1 terminated. 5 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 4, Active not recruiting 1 |
| Phase 1 | 2 | Active not recruiting 1, Completed 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations SENS-501 administration - OTOF Gene Mutation, DFNB9 | Phase 1 / Phase 2 | Active not recruiting | Sensorion | 12 | 2024-06-21 | 2026-07-08 |
| Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis Genotyping, Audiological assessments - Sensorineural Hearing Loss, Bilateral | Terminated | Sensorion | 134 | 2024-06-14 | 2026-10-26 | |
| SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease SENS-401 (R-Azasetron Besylate) - Hearing Loss Ototoxic | Phase 2 | Completed | Sensorion | 48 | 2022-12-30 | 2026-07-02 |
| Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes Pure Tone Audiometry Assessment, Quality of Life Questionnaires - Sensorineural Hearing Loss, Bilateral, AUNB1 | Recruiting | Sensorion | 180 | 2022-11-18 | 2026-06-01 | |
| Evaluation of the Presence of SENS-401 in the Perilymph SENS-401 (R-Azasetron Besylate) - Hearing Loss | Phase 2 | Completed | Sensorion | 28 | 2022-08-10 | 2025-04-23 |
| Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss SENS-401, Placebo Oral Tablet - Severe Sudden Sensorineural Hearing Loss | Phase 2 / Phase 3 | Completed | Sensorion | 115 | 2019-02-15 | 2023-03-01 |
| Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy SENS-111 100mg, SENS-111 200mg, Placebo Oral Tablet - Acute Unilateral Vestibulopathy (AUV) | Phase 2 | Completed | Sensorion | 107 | 2017-08-16 | 2020-10-27 |
| A Study of SENS 401 in Healthy Subjects SENS-401, Placebo - Inner Ear Disease | Phase 1 | Completed | Simbec Research | 36 | 2016-10-21 | 2019-04-08 |
Hearing Loss, Sensorineural (3) · Deafness (2) · Hearing Loss (2) · Deafness, Autosomal Recessive 1A (1) · Deafness, Autosomal Recessive 9 (1) · Ear Diseases (1) · Hearing Disorders (1) · Hearing Loss, Sudden (1) · Labyrinth Diseases (1) · Otorhinolaryngologic Diseases (1) · Presbycusis (1)
SENS-401 (4) · Genotype (1) · seliforant (1)
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Robert Adams, MBBS (1) · Stephen O'Leary, MD (1)
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