EpilepsyNCT05632978
An Observational Study of Epilepsy: Biology and Outcomes Using Real-world Data
An observational study of Epilepsy, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to learn more about phenotypic, genetic, biochemical, neurophysiological and radiological patterns in epilepsy. Participants will be asked to consent to use of clinical and paraclinical data (obtained during standard care) for research, and will be asked to donate blood samples… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2023to Dec 2032
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All people over 16 years old being investigated or followed-up for epilepsy.
Who may be able to join
- Individual is being investigated for epilepsy and under the clinical care of the epilepsy unit at Cardiff \& Vale University Health Board or regional clinics in Cwm Taf.
- Individual is at least 16 years old.
- Informed consent sought and given by individual.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiff and Vale UHB
Cardiff
Khalid Hamandi
About this study
The goal of this observational study is to learn more about phenotypic, genetic, biochemical, neurophysiological and radiological patterns in epilepsy.
Participants will be asked to consent to use of clinical and paraclinical data (obtained during standard care) for research, and will be asked to donate blood samples at their routine clinic visits.
Read the detailed description
This is an observational study of people with epilepsy seen in South Wales, which will employ quantitative methods of analysis to meet the study aims. The study will build upon data already collected during routine clinical appointments from people with epilepsy who have come into contact with the National Health Service (NHS) epilepsy service at Cardiff \& Vale University Health Board. The epilepsy service has clinical data on over 5000 people with epilepsy, and biological samples on approximately 400 people through the Welsh Neuroscience Research Tissue Bank.
The investigators propose to approach individuals being seen in the epilepsy clinics to gain consent for access to their routinely collected clinical and paraclinical data, and prospective donation of biological samples (predominantly blood samples, though consent will be sought for surplus brain tissue and cerebrospinal fluid (CSF) if brain surgery or lumbar puncture are being performed as part of clinical care, as well as hair, nail, and urine in some circumstances). This will enable a comprehensive disease register of a population-based sample of people with epilepsy to be established.
Interrogating the clinical and paraclinical data will allow investigation into clinical phenotypes, short- and long-term outcomes in epilepsy, and the relationship of clinical, demographic and biological variables. Biological samples will allow biochemical and genetic analysis of potential markers of disease, clinical phenotype, and prediction of outcomes including treatment responses, and allow contribution to the Epi25 international collaborative (http://epi-25.org/).
Inclusion in the study will involve no change to the normal clinical care or treatment of participants (except where participants choose to provide biological samples), and additional clinic visits will not be required outside of standard NHS care.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish population-based cohort of people with epilepsy
Establish a population-based cohort of people with epilepsy and associated real-world clinical, paraclinical and biological data.
Measured: 10-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start24 Apr 2023
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Khalid Hamandi, Principal investigator, Cardiff & Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632978
- Sponsor's protocol ID
- 8345
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Epilepsy: Biology and Outcomes Using Real-world Data
- ClinicalTrials.gov ID
- NCT05632978
- Acronym / sponsor ID
- 8345
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 1 Dec 2022 (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.
The goal of this observational study is to learn more about phenotypic, genetic, biochemical, neurophysiological and radiological patterns in epilepsy.
Participants will be asked to consent to use of clinical and paraclinical data (obtained during standard care) for research, and will be asked to donate blood samples at their routine clinic visits.
Detailed description
This is an observational study of people with epilepsy seen in South Wales, which will employ quantitative methods of analysis to meet the study aims. The study will build upon data already collected during routine clinical appointments from people with epilepsy who have come into contact with the National Health Service (NHS) epilepsy service at Cardiff \& Vale University Health Board. The epilepsy service has clinical data on over 5000 people with epilepsy, and biological samples on approximately 400 people through the Welsh Neuroscience Research Tissue Bank.
The investigators propose to approach individuals being seen in the epilepsy clinics to gain consent for access to their routinely collected clinical and paraclinical data, and prospective donation of biological samples (predominantly blood samples, though consent will be sought for surplus brain tissue and cerebrospinal fluid (CSF) if brain surgery or lumbar puncture are being performed as part of clinical care, as well as hair, nail, and urine in some circumstances). This will enable a comprehensive disease register of a population-based sample of people with epilepsy to be established.
Interrogating the clinical and paraclinical data will allow investigation into clinical phenotypes, short- and long-term outcomes in epilepsy, and the relationship of clinical, demographic and biological variables. Biological samples will allow biochemical and genetic analysis of potential markers of disease, clinical phenotype, and prediction of outcomes including treatment responses, and allow contribution to the Epi25 international collaborative (http://epi-25.org/).
Inclusion in the study will involve no change to the normal clinical care or treatment of participants (except where participants choose to provide biological samples), and additional clinic visits will not be required outside of standard NHS care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All people over 16 years old being investigated or followed-up for epilepsy.
Key inclusion criteria (3 listed)
- Individual is being investigated for epilepsy and under the clinical care of the epilepsy unit at Cardiff \& Vale University Health Board or regional clinics in Cwm Taf.
- Individual is at least 16 years old.
- Informed consent sought and given by individual.
Key exclusion criteria (1 listed)
- None
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
Establish population-based cohort of people with epilepsy
Time frame: 10-years
Establish a population-based cohort of people with epilepsy and associated real-world clinical, paraclinical and biological data.
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 23 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Khalid Hamandi principal investigator
Cardiff & Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Khalid Hamandi (+44(0)2921843454, khalid.hamandi@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish population-based cohort of people with epilepsy (time frame: 10-years). 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 23 Oct 2026.