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

  christin.eltze@gosh.nhs.uk

• 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