Voronistat in Pediatric Patients With Drug Resistant Epilepsy

Sponsor
University of Calgary
Study ID
NCT03894826
Phase
PHASE2
Status
Unknown

Conditions

  • Refractory Epilepsy

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat 100 MG — DRUG
    Vorinostat administered by mouth, once daily at a dose of 230 mg/m2/day for a total of 6 weeks

Study Details

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.

Key Dates

Start date
Dec 10, 2018
Status verified
Mar 2019
Primary completion
Apr 30, 2020
Completion
Oct 31, 2020

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TREATMENT
    Participants will be administered 230 mg/m2/day of oral Vorinostat \[100 mg tablets\] in addition to standard of care anti-seizure medication for a duration of 6 weeks.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 14 days post drug initiation; 30 days post drug initiation; 42 days post drug initiation; 42 days following drug discontinuation ]

Central Contacts

Related Studies