A Phase IIa, Multicenter, Randomized, Controlled, Open label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity induced by Cisplatin in Adult Subjects with a Neoplastic Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511713-38-00

Acronym

SENS-401-202

Enrollment

Registered

2024-08-20

Start date

2022-12-30

Completion date

2025-06-11

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cisplatine induced hearing loss

Brief summary

Change from baseline of the average of the hearing threshold of 3 contiguous hearing frequencies assessed with a 0.5-12.5 kHz audiogram 4 weeks after the completion of the last cisplatin treatment in each eligible ear of each subject.

Detailed description

Please cf Protocol (there is too many caracters to be put here)

Interventions

DRUGArazasetron besylate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline of the average of the hearing threshold of 3 contiguous hearing frequencies assessed with a 0.5-12.5 kHz audiogram 4 weeks after the completion of the last cisplatin treatment in each eligible ear of each subject.	—

Secondary

Measure	Time frame
Please cf Protocol (there is too many caracters to be put here)	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026