A retrospective non-interventional study evaluating retention rate of Everolimus as add-on epilepsy therapy in adult patients with tuberose sclerosis

• Conditions: Q85.1; Tuberous sclerosis

• Registration Number: DRKS00020248
• Lead Sponsor: Epilepsiezentrum Kork

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-23
• Study Completion: 2020-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diagnosis epilepsy
• at least 1 epileptic seizure in the year before the onset of everolimus
• Clinically and / or genetically confirmed tuberous sclerosis
• Treatment with everolimus between 01.01.1999 and 30.04.2019
• start treatment with everolimus in adulthood (18 years or older)

Exclusion Criteria

no

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention rate (%) of everolimus after 6 months

Secondary Outcome Measures

Name	Time	Method
Change in the seizure situation after the onset of everolimus,<br>Responder rate (proportion of patients whose seizure frequency has improved by 50% or more),<br>Seizure rate (rate of patients seizure-free after starting everolimus),<br>Seizure situation in the year before Everolimus begins,<br>Seizure situation in the year after beginning of everolimus,<br>Side effects rate<br>Reasons for discontinuation of everolimus