EpilepsyNCT03747705
Trial for Epilepsy Patients Non-responsive to AEDs Using Medical App
An observational study of Epilepsy, run by Tahel Ilan Ber.
Trial summary
Trial for epilepsy patients non-responsive to AEDs, using medical app reminding patients to take their physician-prescribed medications Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- An App for reminding patients to take their medication
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 12 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with drug-resistant epilepsy
Who may be able to join
- Patients in whom seizures are not controlled by their anti-seizure medication
- Must have at least 2 seizures per month
- 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)
- 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)]
- The subject to a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
- History of treatment with at least two AEDs, including one trial of a combination of at least two concomitant drugs, without successful seizure control
Show all 10Show fewer
- Subjects with vagal nerve stimulation system must be in stable settings for a minimum of 6 months prior to enrollment
- 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
- 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
- Anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.
Who cannot join
- Neurodegenerative or deteriorated neurological disease
- Psychosis or past psychotic event and/or anxiety disorder
- Current or history of drug abuse/addiction
- Abnormal creatinine
- Any chronic ophthalmology disease
- The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
Show all 12Show fewer
- Renal, hepatic [ALT/AST >2x upper limit of normal (ULN), bilirubin >2x ULN], pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
- The subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
- 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)
- Unable to comply with study visits/requirements
- Diagnosis of Dravet Syndrome, Lennox-Gastaut syndrome, or any other congenital or childhood syndrome will be excluded completely from this trial
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Controlled Trial for Prevention of Loss of the Effect of Epilepsy Drugs
Trial for epilepsy patients non-responsive to AEDs, using medical app reminding patients to take their physician-prescribed medications
- Conditions
- Epilepsy
- Being tested
- An App for reminding patients to take their medication
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An App for reminding patients to take their medicationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in seizure frequency from baseline to the seizure count evaluation period
Measured: 10 weeks
Secondary outcomes (4)
Change in seizure frequency from baseline to the seizure count evaluation period
Measured: 10 weeks
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Measured: 10 weeks
Changes in the Number of Anti-epileptic Drugs Prescribed
Measured: 10 weeks
Changes in Anti-Epileptic Drugs (AEDs) in patients with less than a 50% reduction in seizures
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Mar 2019 (estimated)
- Primary completion12 Nov 2019 (estimated)
- Study completion12 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tahel Ilan Ber
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Tahel Ilan Ber, Oberon Sciences LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747705
- Sponsor's protocol ID
- Os-001
- Status last verified
- Feb 2019
- First submitted
- 17 Nov 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33988944
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial for Prevention of Loss of the Effect of Epilepsy Drugs
- ClinicalTrials.gov ID
- NCT03747705
- Acronym / sponsor ID
- Os-001
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tahel Ilan BerIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 12 Nov 2019 (estimated)
- Study completion
- 12 Nov 2019 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial for epilepsy patients non-responsive to AEDs, using medical app reminding patients to take their physician-prescribed medications
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with drug-resistant epilepsy
Key inclusion criteria (10 listed)
- Patients in whom seizures are not controlled by their anti-seizure medication
- Must have at least 2 seizures per month
- 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)
- 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)]
- The subject to a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
Key exclusion criteria (12 listed)
- Neurodegenerative or deteriorated neurological disease
- Psychosis or past psychotic event and/or anxiety disorder
- Current or history of drug abuse/addiction
- Abnormal creatinine
- Any chronic ophthalmology disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An App for reminding patients to take their medicationOpen-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. | Other | – |
Primary outcome
Change in seizure frequency from baseline to the seizure count evaluation period
Time frame: 10 weeks
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 33988944Azmanov 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.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Tahel Ilan Ber.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tahel Ilan Ber, MD (+972-523803463, tahel.ilanber@oberon-sci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seizure frequency from baseline to the seizure count evaluation period (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.