NCT06354868Not yet recruiting
A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 158 (estimated)
- First submitted
- 3 Apr 2024
- Start date
- Sept 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Neuronostics Ltd
- Diseases
- Epilepsy
- NCT number
- NCT06354868
What you commit to
- Study type: Observational
- Planned participants: 158
- From Sept 2024 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient receiving low does ASMs for other conditions (migraines etc).
Other illness
- Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).
Other
- Participants unable to tolerate an EEG test so no EEG data were gathered.
- Participants with a known hepatic/renal encephalopathy.
- Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative/observational studies are acceptable).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.