Clinical trial NCT03747705: Trial for Epilepsy Patients Non-responsive to AEDs Using Medical App
Official title: A Controlled Trial for Prevention of Loss of the Effect of Epilepsy Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Oberon Sciences LTD
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with drug-resistant epilepsy

Brief summary: Trial for epilepsy patients non-responsive to AEDs, using medical app reminding patients to take their physician-prescribed medications


Eligibility criteria: Inclusion Criteria:

1. Patients in whom seizures are not controlled by their anti-seizure medication
2. Must have at least 2 seizures per month
3. 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)
4. At least four clinically countable seizures within 4 weeks of study entry \[tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized and/or complex partial seizures and drop attacks (tonic/atonic)\]
5. The subject to a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
6. History of treatment with at least two AEDs, including one trial of a combination of at least two concomitant drugs, without successful seizure control
7. Subjects with vagal nerve stimulation system must be in stable settings for a minimum of 6 months prior to enrollment
8. 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
9. 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
10. Anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.

Exclusion Criteria:

1. Neurodegenerative or deteriorated neurological disease
2. Psychosis or past psychotic event and/or anxiety disorder
3. Current or history of drug abuse/addiction
4. Abnormal creatinine
5. Any chronic ophthalmology disease
6. The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
7. Renal, hepatic \[ALT/AST \>2x upper limit of normal (ULN), bilirubin \>2x ULN\], pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
8. The subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
9. 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)
10. Unable to comply with study visits/requirements
11. Diagnosis of Dravet Syndrome, Lennox-Gastaut syndrome, or any other congenital or childhood syndrome will be excluded completely from this trial
12. 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

Primary outcomes:
measure: Change in seizure frequency from baseline to the seizure count evaluation period
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in seizure frequency from baseline to the seizure count evaluation period
timeFrame: 10 weeks
measure: Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
timeFrame: 10 weeks
measure: Changes in the Number of Anti-epileptic Drugs Prescribed
timeFrame: 10 weeks
measure: Changes in Anti-Epileptic Drugs (AEDs) in patients with less than a 50% reduction in seizures
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Azmanov H, Ross EL, Ilan Y. Establishment of an Individualized Chronotherapy, Autonomic Nervous System, and Variability-Based Dynamic Platform for Overcoming the Loss of Response to Analgesics. Pain Physician. 2021 May;24(3):243-252.