Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy

Phase 2

Completed

• Conditions: 10039911; Epilepsy causes by Tuberous Sclerosis Complex

• Registration Number: NL-OMON36614
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Children with definite TSC older than 3 months, up to 12 yrs old, with catastrophic epilepsy (West syndrome or intractable epilepsy defined as 1 or more seizures/week despite two adequate trials of anti-epileptic drug regimens).

Exclusion Criteria

Renal dysfunction, surgery during 6wk before inclusion, current infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Seizure frequency.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>EEG changes, psychomotor development, behaviour, side effects (safety and<br /><br>tolerability).</p><br>