Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma S.P.R.L.
Age
12–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
2. Has an established diagnosis of partial or generalized epilepsy that includes all the following:
* A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
* A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition
* A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
* A seizure cluster pattern established \>3 months before Visit 1
* A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1
* At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1
3. Currently on a stable regimen of AED(s) that includes a benzodiazepine
4. Weight is 40 kg to 125 kg, inclusive
You may not be if
1. Has a neurological disorder that is likely to progress in the next year
2. Has a severe chronic cardio-respiratory disease
3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
4. Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
5. Has a history of acute narrow-angle glaucoma
6. Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
