A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy

Epilepsy Clinical Trial

— ECLIPSE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354868
• Other study ID #: NNBioEP004
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Neuronostics Ltd
• Contact: Milaana Mainstone
• Phone: +44 (0)117 457 2292
• Email: m.mainstone[@]neuronostics.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Neuronostics Ltd	Cornwall Partnership NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months