205
Participants
Start Date
January 7, 2022
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2026
Zonisamide
The ZON will be supplied in 100 mg capsules and deposited directly into the TAD device by research staff every 2 weeks. All participants will be told to take 100 mg/day for the first three weeks (Week 1-2 single-blind, placebo-only, induction; end of Week 2, active treatment begins) and increasing by 100 mg/day every other week (Week 4: 200 mg/day; Week 6: 300 mg/day; Week 8: 400 mg/day) up to the target dose of 500 mg/day by Week 10. The participants will be maintained on this dose through Week 14 of active treatment and then tapered off ZON (2 weeks). This dosing schedule is consistent with best practices for ZON. All TAD devices will only dispense the prescribed medication between 4pm and 11pm each night. Participants will be instructed to take the medication at or near bedtime.
Placebo
The PLO will be supplied at the same schedule and in the same manner (TAD device) as the ZON.
RECRUITING
Washington State University, Spokane
Washington State University
OTHER