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

Epilepsy Clinical Trial

Official title:

A Controlled Trial for Prevention of Loss of the Effect of Epilepsy Drugs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03747705
• Other study ID #: Os-001
• Status: Not yet recruiting
• Start date: March 1, 2019
• Est. completion date: November 12, 2019

Study information

• Verified date: February 2019
• Source: Oberon Sciences LTD
• Contact: Tahel Ilan Ber, MD
• Phone: +972-523803463
• Email: tahel.ilanber[@]oberon-sci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tahel Ilan Ber

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in seizure frequency from baseline to the seizure count evaluation period		10 weeks
Secondary	Change in seizure frequency from baseline to the seizure count evaluation period		10 weeks
Secondary	Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment		10 weeks
Secondary	Changes in the Number of Anti-epileptic Drugs Prescribed		10 weeks
Secondary	Changes in Anti-Epileptic Drugs (AEDs) in patients with less than a 50% reduction in seizures		10 weeks