Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy
Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
The goal of the present study is to obtain pilot data on efficacy and safety of clobazam
add-on treatment on adults with drug-resistant focal epilepsy.
This will be an open label study comparing seizure frequency during 12 weeks of baseline
observation period with seizure frequency during 16 weeks of clobazam adjunctive treatment.
10 adults aged 18-65 with focal seizures that have failed to respond to ≥ 4 antiepileptic
drugs (AEDs) +/- respective surgery will be enrolled. Following a baseline of 12 weeks
patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in
whom seizure diaries have been kept prospectively prior to study screening visit,
retrospective baseline will be accepted. Patients will be titrated up to either seizure
freedom, to side effects or to 40 mg/day, whichever comes first. Titration rate will be not
be forced. It is anticipated that the majority of subjects will have a 4 week-long titration
period. After maximum dose is achieved, maintenance treatment will last for 12 weeks.