Ep0239 Sleep Disturbances, Behavior, Activities Of Daily Living, And Caregiver Burden Among Patients Diagnosed With Dravet Syndrome And Lennox-Gastaut Syndrome Initiating Treatment With Fenfluramine (Fintepla): A Prospective Multicenter Study
Investigating Sleep and Daily Living in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome (Severe Epilepsy Disorders)
Jason Santiago
Primary Investigator
Brief description of study
Fenfluramine (Fintepla®) is currently approved in your country for the treatment of seizures associated with Dravet syndrome (DS) and for Lennox-Gastaut syndrome (LGS). In addition to seizures, almost all patients experience multiple and significant non-seizure disorders. This study aims to describe the treatment-related impact of fenfluramine on non-seizure outcomes, ie, sleep disturbances (participant and caregiver), behavior, activities of daily living (ADL) and caregiver burden.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
The objective of this study is to describe sleep disturbances (patient and caregiver), behavior, activities of daily living, and caregiver burden among patients diagnosed with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) and newly initiating treatment with fenfluramine.
- This study is expected to last for approximately 18 months; approximately 6 months will be needed for enrollment.
- Each participant will be observed for approximately 6 months after starting the treatment with fenfluramine.
- We will collect health information from participants over 6 months at monthly intervals starting at enrollment baseline and via a web-based platform.
- During the course of the study, caregivers will update monthly questionnaires about the participants' quality of sleep, behavior, activities of daily living, starting from one month after their first dose to the final visit at approximately 6 months
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Dravet Syndrome, Lennox-Gastaut Syndrome
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Age: 18 years - 100 years
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Gender: All
Inclusion criteria
- Diagnosed with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
- Newly initiating treatment with fenfluramine
This study investigates sleep disturbances, behavior, and daily activities in patients with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) who are starting treatment with an investigational medication. Dravet Syndrome and Lennox-Gastaut Syndrome are conditions that affect the brain and can cause seizures. This study looks at how the treatment affects not only seizures but also sleep, behavior, and daily living activities for both patients and their caregivers.
Participants and their caregivers will provide information through a web-based platform. Caregivers will fill out monthly questionnaires about the patient's sleep, behavior, and daily activities. This will help understand how the investigational medication might impact these areas over a six-month period.
- Who can participate: People diagnosed with Dravet Syndrome or Lennox-Gastaut Syndrome who are newly starting treatment with an approved medication can participate. The study is enrolling by invitation only.
- Study details: Participants will provide health information through a web-based platform over six months. Caregivers will fill out monthly questionnaires about sleep, behavior, and daily activities. The study is enrolling by invitation only.
- Study timelines: The study will last 18 months.
