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

NCT06354868 | Not Yet Recruiting

• 1 other identifier: NNBioEP004
• Study Type: observational
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Epilepsy

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

• Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Neuronostics Ltd: lead
• Cornwall Partnership NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Milaana Mainstone

  Neuronostics Ltd

  STUDY DIRECTOR

Central Study Contacts

Milaana Mainstone

CONTACT

+44 (0)117 457 2292; m.mainstone@neuronostics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 13, 2024

Record last verified: 2024-08