Lennox-Gastaut-Syndrome (LGS) Dravet Syndrome (DS) Tuberous Sclerosis complex (TSC) G40.4 G40.8 Q85.1
Conditions
Interventions
Group 1: The study will enroll patients 2 years of age and older who are being treated with Epidyolex® [cannabidiol (CBD)] as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome
Sponsors
Jazz Pharmaceuticals Germany GmbH
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 2 years and older, diagnosed with LGS, DS, or TSC. 2. The decision to prescribe Epidyolex® as an adjunctive therapy for seizures associated with LGS, DS, or TSC was entirely independent of including the patient in the study. 3. Patient, or parent(s)/legal representative(s) must be willing and able to give informed consent/assent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. The patient is currently using or have used cannabis-based products (including recreational, medicinal cannabis, or any other cannabinoid-based products) within the 3 months prior to study entry, unless that has already been observed as part of this study. 2. The patient who is already enrolled in any other Jazz-sponsored or funded study must not be enrolled. If a patient is enrolled in another Jazz-sponsored or funded study while they are under observation of the PROGRESS study, their participation in the PROGRESS study must be terminated. 3. The patient has the indication LGS or DS and is receiving Epidyolex® not in conjunction with clobazam, and therefore not according to SmPC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the retention rate (as a proxy of effectiveness and tolerability) of Epidyolex® prescribed for use in patients with LGS, DS, or TSC patients receiving Epidyolex® per normal clinical care | — |
Secondary
| Measure | Time frame |
|---|---|
| • To describe the change in Non-seizure related outcomes (NSRO) • To describe seizure-free days and seizure free intervals in patients receiving Epidyolex® • To describe changes in overall condition in patients receiving Epidyolex® • To describe safety and tolerability in routine clinical practice in patients receiving Epidyolex® Exploratory outcomes: • To describe the changes in seizure frequency in patients receiving Epidyolex® • To describe seizure response in patients receiving Epidyolex®. | — |
Countries
Germany
Contacts
Public ContactHans-Ulrich Peltner
MZEB am Krankenhaus Marienstift
Outcome results
None listed