Refractory Epilepsy Clinical Trial
Official title:
A Phase 2 Clinical Trial Testing the Safety and Efficacy of Voronistat in Pediatric Patients With Drug Resistant Epilepsy
The study evaluates the safety, tolerability, and efficacy of Vorinostat in addition to standard of care anti-epileptic drugs in pediatric patients with medically refractory epilepsy. All participants entering the treatment phase will receive Vorinostat.
Vorinostat is a potent inhibitor of histone deacetylases (HDAC). HDACs catalyze the removal
of acetyl groups from the lysine residues of proteins, including histones and transcription
factors. Valproic acid, a broad anti-epileptic drug, commonly used as first line treatment in
epilepsy, has also been shown to inhibit HDAC activity .
It is it is anticipated that Vorinostat in a population of pediatric patients with epilepsy
will be well-tolerated, similar to that seen with valproic acid and other normally prescribed
anti-epileptic drugs.
Participants consenting to participate will enter a 4-week screening period to ensure
eligibility. Eligible participants will then enter the 6-week treatment phase. Participants
will be seen for a final Safety Follow-up visit 6 weeks after end of treatment. Participants
who are enrolled and complete all study procedures will be in the study for a total of 16
weeks.
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