Dravet & Lennox-Gastaut Syndrome - A chart review for patients in EAPs
Research type
Research Study
Full title
Exploring the clinical outcomes and treatment patterns for patients with Dravet Syndrome and Lennox-Gastaut Syndrome during an Early Access Program in UK
IRAS ID
304013
Contact name
Christin Eltze
Contact email
Sponsor organisation
Gw Pharmaceuticals P.l.c.
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
This is a UK based, multi-centre non-interventional observational study aimed at collecting data of Epidyolex® (cannabidiol) in patients with Dravet Syndrome and Lennox-Gastaut Syndrome during the Early Access Program (EAP). The research is designed to collect data on patients whose seizures were not controlled by their current anti-seizure drug regimen and thus received the drug as part of EPA. Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) are rare, treatment-resistant epileptic disorders and patients have frequent, debilitating seizures, neurodevelopmental and motor impairments. Given the paucity of data related to these conditions that provide a little insight into patient outcomes, the objective of this study is to provide additional real-world insights into the disease, current treatment patterns, clinical outcomes, and healthcare resource use.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0414
Date of REC Opinion
3 Dec 2021
REC opinion
Favourable Opinion