Clinical trial NCT05258773: Evaluation of the Presence of SENS-401 in the Perilymph
Official title: A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph After 7 Days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hearing Loss
Lead sponsor: Sensorion
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.

Detailed description: The study is a Phase IIa, open-label, randomized and controlled study investigating repeated twice-daily administration of oral SENS-401 in adult participants with moderately severe to profound hearing loss who have already agreed to undergo cochlear implant surgery justified by their hearing impairment.

After written informed consent is obtained and screening procedures completed, 27 eligible participants will be randomized on Day 1 to either Arm A or Arm B in ratio 2:1 (18 participants in Arm A and 9 participants in Arm B).

Arm A participants will commence dosing with twice-daily oral 43.5 mg SENS-401 for 7 days prior to their scheduled cochlear implant surgery on Day 8 and up to 42 days from day of surgery inclusive.

Arm B participants will not receive any treatment other than their scheduled cochlear implant surgery.

Eligibility criteria: Main Inclusion Criteria:

Potential participants must fulfil all of the following main inclusion criteria to be eligible for the study:

1. Adults aged from 18 years and older;
2. Meets the locally approved indication for cochlear implantation. The individual must have freely consented to the cochlear implant surgery before being offered to participate in the SENS-401-203 study;
3. Signed and dated written informed consent;

Main Exclusion Criteria:

Individuals will be excluded from the study if any of the following main exclusion criteria apply:

1. Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 ml/min
2. Any condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study
3. Unable or unwilling to comply with the protocol requirements
4. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction

Primary outcomes:
measure: Proportion of Participants With SENS-401 Detected in Perilymph
timeFrame: Day 8
Secondary outcomes:
measure: SENS-401 Perilymph Concentration
timeFrame: Day 8
measure: SENS-401 Plasma Concentration
timeFrame: Day 8
measure: Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies
timeFrame: Day 49 and Day 105
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Victorian Eye and Ear Hospital
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille Hôpital Roger Salengro
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Groupe Hospitalier La Pitié-Salpétrière
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan
Study officials:
affiliation: Royal Victoria Eye and Ear Hospital
name: Stephen O'Leary, MD
role: PRINCIPAL_INVESTIGATOR
References: