Trials / Recruiting
RecruitingNCT06370351
A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
A Phase I/II, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children with Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Sensorion · Industry
- Sex
- All
- Age
- 6 Months – 31 Months
- Healthy volunteers
- Not accepted
Summary
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
Detailed description
It is a multicenter, adaptive open-label, non-randomized, dose-escalation, and expansion study to assess safety, tolerability, and efficacy following intracochlear administration of SENS-501.
Conditions
- OTOF Gene Mutation
- DFNB9
- Congenital Deafness
- Hearing Disorders
- Ear Diseases
- Otorhinolaryngologic Diseases
- Deafness
- Hearing Loss, Sensorineural
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | SENS-501 administration | Administration of SENS-501 with a dedicated administration system |
Timeline
- Start date
- 2024-06-21
- Primary completion
- 2027-07-01
- Completion
- 2031-07-01
- First posted
- 2024-04-17
- Last updated
- 2024-09-26
Locations
2 sites across 2 countries: Australia, France
Source: ClinicalTrials.gov record NCT06370351. Inclusion in this directory is not an endorsement.