Trial for Epilepsy Patients Non-responsive to AEDs Using Medical App
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
Other: An App for reminding patients to take their medication
Open-label, single-center study, up to 20 adults (>18) male and female with, intractable epilepsy, on stable doses of antiepileptic drugs (AEDs), will participate in a 4-week observation period during which no change in the drugs is permitted. The patients will then begin 10-week treatment by taking their medications according to a semi-random schedule that is pre-set for them by the physician using the same drugs the patient is taking and only changing the dose and times of taking them each day while keeping the drugs within their therapeutic window. Between 6:00-22:00 During the study, patients will fill a seizure diary daily.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adults with drug-resistant epilepsy
Patients in whom seizures are not controlled by their anti-seizure medication
Must have at least 2 seizures per month
History of any of the following seizure types: tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized, complex partial seizures and drop attacks (tonic/atonic)
At least four clinically countable seizures within 4 weeks of study entry [tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized and/or complex partial seizures and drop attacks (tonic/atonic)]
The subject to a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
History of treatment with at least two AEDs, including one trial of a combination of at least two concomitant drugs, without successful seizure control
Subjects with vagal nerve stimulation system must be in stable settings for a minimum of 6 months prior to enrollment
RNS deep brain stimulation or the ketogenic diet can be considered equivalent to a drug trial and must be on a stable ratio for a minimum of 3 months prior to enrollment
Completed seizure diary for four weeks (±3 days) prior to initiation of the dose titration period (visit 2). The subject will be considered a screen failure if seizure diary was not appropriately completed
Anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.
Neurodegenerative or deteriorated neurological disease
Psychosis or past psychotic event and/or anxiety disorder
Current or history of drug abuse/addiction
Any chronic ophthalmology disease
The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
Renal, hepatic [ALT/AST >2x upper limit of normal (ULN), bilirubin >2x ULN], pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
The subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
The subject is currently enrolled in or has not yet completed a period of at least 60 days since ending another investigational device or drug trial(s)
Unable to comply with study visits/requirements
Diagnosis of Dravet Syndrome, Lennox-Gastaut syndrome, or any other congenital or childhood syndrome will be excluded completely from this trial
Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a serum pregnancy test before entry into the study. Female subjects will be informed not to become pregnant while on trial. Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study