Trial for Epilepsy Patients Non-responsive to AEDs Using Medical App

NCT ID: NCT03747705

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-11-12

Brief Summary

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

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tahel Ilan Ber

INDUSTRY

Sponsor Role: lead

Responsible Party

Tahel Ilan Ber

CMO

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Tahel Ilan Ber, MD

Role: CONTACT

tahel.ilanber@oberon-sci.com

+972-523803463

References

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.

Reference Type: DERIVED

PMID: 33988944 (View on PubMed)

Other Identifiers

Os-001

Identifier Type: -

Identifier Source: org_study_id