This is a research study to evaluate a medication for the treatment of status epilepticus. Status epilepticus is a condition when a patient has continuous seizure activity which usually causes them to be unconscous, be very confused and sometimes to have abnormal body movements. Sometime status epilepticus will not stop after treatment with medications which are currently used by doctors. New medications to stop status epilepticus are needed. This is a study of a medication called ganalaxone which would be administered intravenously to patients with status epilepticus after two typical medications have been tried and not worked. This is a placebo controlled study, meaning that some of the patients will be randomly selected to receive the study medication and some will be selected to receive the placebo medication (which in this case is just salt water given intravenously). Patients in the study will be monitored using continuous electroencephalography (EEG) monitoring and physical exams to determine if the status epilepticus stops. Patients will be called several weeks after treatment to see how well they are doing.
This 57-week, active-treatment, open-label (all participants will receive study drug throughout the study) extension trial ( enrolls participants of a previous clinical trial into another study) in which all participants gets the study drug is designed to assess the safety and tolerability of CVL-865 as adjunctive treatment (another treatment used together with the primary treatment) in subjects with drug-resistant focal onset seizures. This trial is open to subjects who completed treatment with the investigational medicinal product (IMP) in the double-blind (neither the participant or researchers know what study drug they are receiving) Phase 2 Trial CVL-865-SZ-001 and who, in the opinion of the investigator, could potentially benefit from treatment with CVL-865. There are 17 visits for a duration of 57 active-treatment weeks. The visits are approximately one month apart.
The purpose of this study is to find out if a drug called CVL-865 is safe and effective in the treatment for focal onset epilepsy. The study has an 8-week screening period, followed by a treatment period where adults 18 - 75 years of age that qualify for treatment will be randomly assigned to 3 different dose levels of the study drug. This is followed by a 4-week safety follow up period. The study will last approximately 25 weeks with approximately 7 research related clinic appointments. Participants that successfully complete the treatment period will also have the option of participating in a separate open-label extension study and all participants will be taking the study drug.