EpilepsyECLIPSENCT06354868
A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy
An observational study of Epilepsy, run by Neuronostics Ltd.
Trial summary
This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the first seizure clinic, receive a routine EEG, receive a diagnosis of epilepsy and are commenced an ASM.
Who may be able to join
- Adult (age 18 and above) presenting with first suspected seizure(s).
- Able to give informed consent.
- Patient has received an initial epilepsy diagnosis.
- Patient accepts decision to commence ASM.
- Have an EEG prior to commencing ASMs.
- Participants under watchful waiting who subsequently return to clinic for an epilepsy diagnosis (following a second seizure or a positive EEG) can be included in the study. They must have had an EEG performed in the 12 months prior to be being included in the study (to be used as a baseline EEG) and not have been taking any ASMs at the time.
Who cannot join
- Participants unable to tolerate an EEG test so no EEG data were gathered.
- Participants with a known hepatic/renal encephalopathy.
- Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).
- Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative/observational studies are acceptable).
- Patient receiving low does ASMs for other conditions (migraines etc).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Observational Clinical Study to Investigate the Relationship Between Seizure Frequency and BioEP During ASM Titration in Newly Diagnosed Patients With Epilepsy, and to Assess the Utility of BioEP as an Early Prognostic Indicator of Anti-seizure Medication (ASM) Efficacy
This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy
Read the detailed description
The study will consist of a cohort of adult patients who present to first seizure clinics. The patients will have had an EEG performed as part of the clinical care pathway (this will act as their baseline reference BioEP value). They will also have received an epilepsy diagnosis and will be due to start ASM titration as part of their epilepsy treatment. One stop clinics shall be targeted primarily for their same day EEGs service, to allow a baseline EEG to be obtained prior to the patient starting ASMs in those who get an EEG diagnosis on the same day.
Patients who have initially seen a Neurologist in a first seizure clinic and are under a period of watchful waiting, and then return to the clinic a second time and receive an epilepsy diagnosis will be eligible to enter the trial. The second encounter with Neurology would usually be due to the occurrence of a second seizure or by a positive EEG being recorded as part of their usual care during the watch and wait period and the clinician deciding to start ASMS on that basis. The study will utilise their 1st EEG performed as the baseline EEG (provided this is performed within a 12-month window prior to their second Neurology encounter and during a period of no ASMs).
A baseline BioEP result shall be gathered from baseline EEG data prior to commencement of the ASM titration regime and a set of computational biomarkers (BioEP) shall be identified from relevant EEG segments free of IEDs. In addition to the clinical care pathway, participants will also receive additional routine EEGs at 1, 3 and 6 and 12 months after commencing treatment. The EEGs performed at 1, 3, 6 and 12 months duration shall also have their BioEP results identified at these specified time points.
Any patient who requires a ASM medication change during the first 6 months of the trial, an additional EEG will be collected at 9 months, and then again at the usual 12 months' time point.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between BioEP and seizure frequency.
Identify a ratio of change of BioEP result from baseline (prior to ASMs commencing) to maximal effects of the ASM intervention and seizure control.
Measured: 12 months
Secondary outcomes (1)
Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change
The investigators will examine the association between the 12-month change from baseline in BioEP score and reporting at least 'a little improved' on the 7-point patient global impression of change scale. Minimum value 1 = very much improved, maximum value 7 = very much worse A higher score means a worse outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuronostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cornwall Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Milaana Mainstone, Study director, Neuronostics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354868
- Sponsor's protocol ID
- NNBioEP004
- Acronym
- ECLIPSE
- Status last verified
- Aug 2024
- First submitted
- 3 Apr 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Clinical Study to Investigate the Relationship Between Seizure Frequency and BioEP During ASM Titration in Newly Diagnosed Patients With Epilepsy, and to Assess the Utility of BioEP as an Early Prognostic Indicator of Anti-seizure Medication (ASM) Efficacy
- ClinicalTrials.gov ID
- NCT06354868
- Acronym / sponsor ID
- ECLIPSE / NNBioEP004
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Neuronostics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cornwall Partnership NHS Foundation Trust
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Apr 2024 (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.
This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy
Detailed description
The study will consist of a cohort of adult patients who present to first seizure clinics. The patients will have had an EEG performed as part of the clinical care pathway (this will act as their baseline reference BioEP value). They will also have received an epilepsy diagnosis and will be due to start ASM titration as part of their epilepsy treatment. One stop clinics shall be targeted primarily for their same day EEGs service, to allow a baseline EEG to be obtained prior to the patient starting ASMs in those who get an EEG diagnosis on the same day.
Patients who have initially seen a Neurologist in a first seizure clinic and are under a period of watchful waiting, and then return to the clinic a second time and receive an epilepsy diagnosis will be eligible to enter the trial. The second encounter with Neurology would usually be due to the occurrence of a second seizure or by a positive EEG being recorded as part of their usual care during the watch and wait period and the clinician deciding to start ASMS on that basis. The study will utilise their 1st EEG performed as the baseline EEG (provided this is performed within a 12-month window prior to their second Neurology encounter and during a period of no ASMs).
A baseline BioEP result shall be gathered from baseline EEG data prior to commencement of the ASM titration regime and a set of computational biomarkers (BioEP) shall be identified from relevant EEG segments free of IEDs. In addition to the clinical care pathway, participants will also receive additional routine EEGs at 1, 3 and 6 and 12 months after commencing treatment. The EEGs performed at 1, 3, 6 and 12 months duration shall also have their BioEP results identified at these specified time points.
Any patient who requires a ASM medication change during the first 6 months of the trial, an additional EEG will be collected at 9 months, and then again at the usual 12 months' time point.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the first seizure clinic, receive a routine EEG, receive a diagnosis of epilepsy and are commenced an ASM.
Key inclusion criteria (6 listed)
- Adult (age 18 and above) presenting with first suspected seizure(s).
- Able to give informed consent.
- Patient has received an initial epilepsy diagnosis.
- Patient accepts decision to commence ASM.
- Have an EEG prior to commencing ASMs.
Key exclusion criteria (5 listed)
- Participants unable to tolerate an EEG test so no EEG data were gathered.
- Participants with a known hepatic/renal encephalopathy.
- Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).
- Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative/observational studies are acceptable).
- Patient receiving low does ASMs for other conditions (migraines etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between BioEP and seizure frequency.
Time frame: 12 months
Identify a ratio of change of BioEP result from baseline (prior to ASMs commencing) to maximal effects of the ASM intervention and seizure control.
1 secondary outcome
Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
Milaana Mainstone study director
Neuronostics Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Neuronostics Ltd.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milaana Mainstone (+44 (0)117 457 2292, m.mainstone@neuronostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between BioEP and seizure frequency. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.