FDA Patient Affairs hosts Patient Listening Sessions. These sessions are a resource for the medical product Centers to engage with patients and their advocates. Patient Listening Sessions are one of several ways the patient and advocacy community can share their experiences and perspectives by talking directly with FDA staff.

On April 22, 2024, the KCNT1 Epilepsy Foundation held a Patient-led Listening Session with the Food and Drug Administration.

Objective of Session:

The objective of the session was to provide FDA staff with the opportunity to hear about the lives of patients and families living with KCNT1-related epilepsy, the urgent need for treatments, what caregivers feel would be meaningful treatment outcomes and their risk tolerance to obtain those outcomes.

Agenda:

·      Introduction & welcome from the FDA

·      Foundation introduction & overview of KCNT1-related epilepsy

·      Shared stories of parent / caregiver lived experience

·      Moderated discussion of goals and preferences for treatments and participation in trials

·      Clinician perspective

·      Moment of silence for our lost warriors

·      FDA Q & A