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

ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNeuronostics Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

Patients presenting to the first seizure clinic, receive a routine EEG, receive a diagnosis of epilepsy and are commenced an ASM.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neuronostics Ltd

Lead sponsor

Cornwall Partnership NHS Foundation Trust

Collaborator

This trial is not recruiting at the moment. You can still explore other options: