arazasetron (SENS-401) / Sensorion - LARVOL DELTA

NOTOXIS: SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: Sensorion | Recruiting ➔ Active, not recruiting | Trial completion date: May 2025 ➔ Aug 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Otorhinolaryngology

Sensorion Announces the End of Patient Inclusion in NOTOXIS Phase 2a Clinical Trial of SENS-401 for the Prevention of Cisplatin-Induced Ototoxicity (Businesswire) - "Sensorion...today announced the enrollment of the last patient in its NOTOXIS Proof of Concept (POC) Phase 2a clinical trial of SENS-401 for the prevention of Cisplatin-Induced Ototoxicity (CIO)....Sensorion is on track to report topline results of the Phase 2a NOTOXIS study end of H2 2025....'The preliminary results are encouraging, and I look forward to assessing the full data of all patients treated in NOTOXIS and communicating the topline results of this trial by end of 2025.'"

Enrollment status • P2a data • Oncology • Otorhinolaryngology

NOTOXIS: SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease (clinicaltrials.gov) - P2 | N=58 | Recruiting | Sponsor: Sensorion | Phase classification: P2a ➔ P2 | Trial completion date: Aug 2024 ➔ May 2025 | Trial primary completion date: Jun 2024 ➔ Mar 2025

Phase classification • Trial completion date • Trial primary completion date • Oncology • Otorhinolaryngology

Efficacy and safety of SENS-401 in sudden sensorineural hearing loss: The AUDIBLE-S randomized placebo-controlled phase IIb trial. (PubMed, Am J Otolaryngol) - "While the primary endpoint was not achieved at the end of the treatment period, the study revealed consistently positive efficacy results of clinical relevance in patients with idiopathic SSNHL who received SENS-401, particularly in the 8-weeks follow-up phase after the completion of the treatment."

Journal • P2b data • Mood Disorders • Otorhinolaryngology

Sensorion Announces Positive Recommendation From the Data Safety Monitoring Board (DSMB) Regarding the Continuation of NOTOXIS, its Phase 2a Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity (Businesswire) - "Sensorion...announces that the independent Data Safety Monitoring Board (or DSMB) has undertaken a review of the safety data for the patients participating in the NOTOXIS Phase 2a Proof-of-Concept (POC) clinical study of SENS-401 for the prevention of Cisplatin-Induced Ototoxicity...The DSMB has recommended the continuation of the study and confirmed the absence of any concern as to the safety of SENS-401 when administered in adult patients receiving a daily dose of 43.5 mg, administered twice daily, over a period of up to 23 weeks...The patient enrolment continues to progress at a steady pace, in 13 clinical centers open to date. Sensorion's management team will report preliminary safety and efficacy data of the Phase 2a POC clinical trial of SENS-401 CIO at the World Congress of Audiology, to be held on September 19-22, 2024, in Paris, France."

DSMB • P2a data • Trial status • Oncology

Sensorion Announces Upcoming Presentation of Promising SENS-401 Results at the Next International Conference on Cochlear Implants and Other Implantable Technologies (Businesswire) - "Sensorion...today announces that promising new data and analysis results from the SENS-401 following cochlear implantation Phase 2a clinical study will be presented at the 17th International Conference on Cochlear Implants and Other Implantable Technologies (CI2024) taking place on July 10-13, 2024, in Vancouver, Canada...Early Preservation of Residual Hearing Six Weeks Post Cochlear Nucleus CI622 Implantation and Detection of SENS-401 in Perilymph: Findings from a Phase IIa Clinical Trial Investigating Repeated Oral Administration of SENS-401 in Implant Patients..."

P2a data • Otorhinolaryngology

Evaluation of the Presence of SENS-401 in the Perilymph (clinicaltrials.gov) - P2 | N=28 | Completed | Sponsor: Sensorion | Active, not recruiting ➔ Completed

Trial completion • Otorhinolaryngology

Evaluation of the Presence of SENS-401 in the Perilymph (clinicaltrials.gov) - P2 | N=27 | Active, not recruiting | Sponsor: Sensorion | Recruiting ➔ Active, not recruiting

Enrollment closed • Otorhinolaryngology

Evaluation of the Presence of SENS-401 in the Perilymph (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: Sensorion

Trial completion date • Trial primary completion date • Otorhinolaryngology

Sensorion Provides an Update on NOTOXIS, its Proof of Concept Phase 2a Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) (Businesswire) - P2a | N=58 | NOTOXIS (NCT05628233) | Sponsor: Sensorion | "The Phase 2a NOTOXIS trial is a multicenter, randomized, controlled, open-label study, designed to evaluate the efficacy of SENS-401 to prevent ototoxicity induced by cisplatin in adult patients with a neoplastic disease 4 weeks after the completion of cisplatin-based chemotherapy....Following the enrolment of over one-third of the required study population, preliminary safety data for patients exposed to a daily dose of 43.5 mg SENS-401 administered b.i.d. for up to 11 weeks indicate a favorable profile consistent with previously reported data for patients exposed for up to 7 weeks....Recruitment is progressing at a sustained path, with 11 clinical centers open to date. Sensorion’s management team will communicate further updates of the POC Phase 2a clinical study of SENS-401 in Cisplatin-Induced Ototoxicity during the World Congress of Audiology, being held on September 19-22, 2024, in Paris, France."

P2a data • Trial status • Oncology

Evaluation of the Presence of SENS-401 in the Perilymph (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: Sensorion | Phase classification: P2a ➔ P2

Phase classification • Otorhinolaryngology

NOTOXIS: SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease (clinicaltrials.gov) - P2a | N=58 | Recruiting | Sponsor: Sensorion | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Otorhinolaryngology

NOTOXIS: SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease (clinicaltrials.gov) - P2a | N=58 | Not yet recruiting | Sponsor: Sensorion

New P2a trial • Oncology • Otorhinolaryngology