NCT06370351 A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
| NCT ID | NCT06370351 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sensorion |
| Condition | OTOF Gene Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-06-21 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-06-21 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Children (male or female) ≥ 6 to ≤ 31 months at the time of inclusion * Severe to profound hearing loss assessed by auditory brainstem response (ABR) * Biallelic mutation in the Otoferlin gene * Presence of Otoacoustic emissions (OAEs) * Documented normal cochlea and internal auditory canals * Patients with intact vestibular function Exclusion Criteria: * History of chronic, acute, or major disease, or unspecified reasons, that in the opinion of the Investigator, makes the participant unsuitable for participation in the study or constitutes an unacceptable risk. * Have been dosed in a previous gene therapy clinical trial * Patients with a prior or current cochlear implant * Any contraindication to the surgery determined by the surgeon or anesthesia determined by the anesthesiologist, or designee, or history of therapy known as ototoxic (e.g., cisplatin, high dose and long treatment with aminoglycosides, etc.) for an extended period (more than 2 weeks). * Participation in any other interventional clinical trial * Any other 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 or might interfere with the evaluation of study treatment * Anticipated noncompliance with the protocol requirements
Contact & Investigator
Natalie LOUNDON, Pr
STUDY CHAIR
Hopital Necker Enfants Malades
Frequently Asked Questions
Who can join the NCT06370351 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 31 Months, studying OTOF Gene Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06370351 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06370351 currently recruiting?
Yes, NCT06370351 is actively recruiting participants. Contact the research team at lionel.hovsepian@sensorion-pharma.com for enrollment information.
Where is the NCT06370351 trial being conducted?
This trial is being conducted at Westmead, Australia, Paris, France.
Who is sponsoring the NCT06370351 clinical trial?
NCT06370351 is sponsored by Sensorion. The principal investigator is Natalie LOUNDON, Pr at Hopital Necker Enfants Malades. The trial plans to enroll 12 participants.