Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03747705
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Tahel Ilan Ber, Oberon Sciences LTD

Tracking Information
First Submitted Date November 17, 2018
First Posted Date November 20, 2018
Last Update Posted Date February 5, 2019
Estimated Study Start Date March 1, 2019
Estimated Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2018)
Change in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 10 weeks ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03747705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 19, 2018)
  • Change in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 10 weeks ]
  • Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment [ Time Frame: 10 weeks ]
  • Changes in the Number of Anti-epileptic Drugs Prescribed [ Time Frame: 10 weeks ]
  • Changes in Anti-Epileptic Drugs (AEDs) in patients with less than a 50% reduction in seizures [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Brief Summary Trial for epilepsy patients non-responsive to AEDs, using medical app reminding patients to take their physician-prescribed medications
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with drug-resistant epilepsy
Condition 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 19, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 12, 2019
Estimated Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tahel Ilan Ber, MD +972-523803463 tahel.ilanber@oberon-sci.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03747705
Other Study ID Numbers Os-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Tahel Ilan Ber, Oberon Sciences LTD
Study Sponsor Tahel Ilan Ber
Collaborators Not Provided
Investigators Not Provided
PRS Account Oberon Sciences LTD
Verification Date February 2019