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Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants — STOP2  

Epilepsy Clinical Trial

Official title:
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants

Clinical Trial Summary

This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).

Clinical Trial Description

Tuberous Sclerosis Complex (TSC) is caused by genetic mutation in TSC1 or TSC2, resulting in dysregulation of the mechanistic target of rapamycin (mTOR) signaling pathway. Age at time of seizure onset in TSC infants has been linked to long-term neurodevelopmental outcome in this high-risk population. TAVT-18 is a novel formulation of sirolimus, an mTOR inhibitor. This study evaluates TAVT-18 as a targeted, disease-modifying drug therapy for preventing or delaying seizure onset in TSC using a rational, mechanism-based therapeutic approach. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04595513
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 8, 2020
Completion date December 15, 2022
View Details
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