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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

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

Condition or disease Intervention/treatment
Epilepsy Other: An App for reminding patients to take their medication

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Controlled Trial for Prevention of Loss of the Effect of Epilepsy Drugs
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : November 12, 2019
Estimated Study Completion Date : November 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention 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.


Primary Outcome Measures :
  1. Change in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Change in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 10 weeks ]
  2. 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 ]
  3. Changes in the Number of Anti-epileptic Drugs Prescribed [ Time Frame: 10 weeks ]
  4. Changes in Anti-Epileptic Drugs (AEDs) in patients with less than a 50% reduction in seizures [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with drug-resistant epilepsy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747705


Contacts
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Contact: Tahel Ilan Ber, MD +972-523803463 tahel.ilanber@oberon-sci.com

Sponsors and Collaborators
Tahel Ilan Ber

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Responsible Party: Tahel Ilan Ber, CMO, Oberon Sciences LTD
ClinicalTrials.gov Identifier: NCT03747705     History of Changes
Other Study ID Numbers: Os-001
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases