EpilepsyREFINENCT06780501
Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (REFINE)
An observational study of Epilepsy and Intellectual Disability, run by University of Plymouth at 3 sites in United Kingdom.
Trial summary
This study consists of two parts: Part One: De-identified Database The goal of this part is to establish a research database containing de-identified data about People with Intellectual Disabilities (PwID) and epilepsy, collected from three NHS sites across England and Wales. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Intellectual Disability, Learning Disability
- How many people
- 600 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 12 Sep 2024to 31 May 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a clinical diagnosis of an Intellectual Disability (ID) and epilepsy at participating sites.
Who may be able to join
- Clinical diagnosis of ID in medical records.
- Clinical diagnosis of epilepsy in medical records.
- Patient is over the age of 18 years old.
- Under the current care of specialist ID or epilepsy services at one of the three participating NHS Trusts.
- Clinical diagnosis of ID in medical records.
- Clinical diagnosis of epilepsy in medical records.
Show all 10Show fewer
- Under the current care of specialist ID or epilepsy services at one of the three participating NHS Trusts.
- Between the ages of 18 and 30 at the time of consent.
- Participant has the capacity to be able to provide consent for themselves, or a personal consultee is able to provide an opinion on the views and feelings of the potential participant.
- Patients (or personal consultee) must be able to communicate in English (or Welsh in Welsh site).
Who cannot join
- Other neurodevelopmental disorders without ID.
- Patient is recorded on the National Data Opt-out as not wishing their data to be used for research/audit.
- The research register:
- Other neurodevelopmental disorders without ID.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Cornwall Partnership NHS Foundation Trust
Bodmin
Sarah Lennard
Sarah Lennard
- Not yet recruiting
Royal Free London Hospitals NHS Trust
London
Heather Angus-Leppan
Heather Angus-Leppan
- Recruiting
Swansea Bay University Health Board
Swansea
Lance Watkins
Lance Watkins
About this study
This study consists of two parts:
Part One: De-identified Database
Read more
The goal of this part is to establish a research database containing de-identified data about People with Intellectual Disabilities (PwID) and epilepsy, collected from three NHS sites across England and Wales. Researchers will gather information from participants' medical records, including clinical details, epilepsy history, and medications, and will enter this data into a secure database where all identifying details are removed. This part of the study aims to determine whether it's possible to identify eligible participants, collect complete datasets for each participant, and identify any issues that may affect the quantity and quality of data. These findings will help inform a potential future study that could involve 20 or more sites.
Part Two: Research Register
The goal of this part is to create a research register of individuals with PwID and epilepsy. Participants will be approached and asked for their consent to collect their personal and clinical data, which will help identify those willing to take part in future ethically approved research projects. As in Part One, researchers will collect data from medical records. Participants who consent to be included in the register may be contacted by external researchers for future studies. The aim is to facilitate national collaboration by enabling data sharing between research projects, thereby improving the ability to answer more questions and enhance patient care. This part of the study will test whether it's possible to determine screening and recruitment rates at each site, develop and evaluate recruitment processes, and assess how researchers leading other approved studies can obtain permission to use the register. Additionally, it will evaluate whether it's possible to collect a complete dataset for each participant.
- Conditions
- Epilepsy, Intellectual Disability, Learning Disability
- Medical subject headings
- Epilepsy, Intellectual Disability, Learning Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
The set up of a research database consisting of de-identified data focused on People with Intellectual Disabilities (PwID) and epilepsy at three UK NHS sites across England and Wales.
De-identified database
Measured: End of study (May 2025)
The development of a research register of PwID and epilepsy. Participants will consent to the collection of their personal/clinical data, which will enable the identification of patients willing to take part in other ethically approved research projects.
Research register
Measured: End of study (May 2025)
Secondary outcomes (7)
Numbers of eligible patients identified at each site for data collection (De-identified database).
Feasibility objective
Measured: End of study (May 2025)
Completeness of clinical data collected (De-identified database)
Feasibility objective
Measured: End of study (May 2025)
Feedback collected from sites about any issues around identifying patients and locating the data required (De-identified database).
Feasibility objective
Measured: End of study (May 2025)
Screening and recruitment rates at each site (Research register).
Feasibility objective
Measured: End of study (May 2025)
Successful recruitment process in place at each site (Research register).
Feasibility objective
Measured: End of study (May 2025)
Set up of a formal process including the REFINE Study Oversight Committee to review requests for access to the participant register (Research register).
Feasibility objective
Measured: End of study (May 2025)
Completeness of clinical data collected (Research register).
Feasibility objective
Measured: End of study (May 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start12 Sep 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Rohit Shankar, University of Plymouth
- Investigators
- Lance Watkins, Principal investigator, Swansea Bay University Health BoardSarah Lennard, Principal investigator, Cornwall Partnership NHS Foundation TrustHeather Angus-Leppan, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780501
- Sponsor's protocol ID
- 5284
- Acronym
- REFINE
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Musicha C, Neilens H, Stanyard E, Allgar V, Lomax J, Ashford R, Hambly H, Aspinall P, O'Shaughnessy E, Rollinson C, Lennard S, Mclean B, Simpson A, Bowman P, Angus-Leppan H, Watkins L, Laugharne R, Allard J, Shankar R. Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol. BMJ Open. 2025 Nov 26;15(11):e108869. doi: 10.1136/bmjopen-2025-108869.
PubMed 41298255
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (REFINE)
- ClinicalTrials.gov ID
- NCT06780501
- Acronym / sponsor ID
- REFINE / 5284
- Conditions
- Epilepsy, Intellectual Disability, Learning Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 17 Jan 2025 (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.
This study consists of two parts:
Part One: De-identified Database
The goal of this part is to establish a research database containing de-identified data about People with Intellectual Disabilities (PwID) and epilepsy, collected from three NHS sites across England and Wales. Researchers will gather information from participants' medical records, including clinical details, epilepsy history, and medications, and will enter this data into a secure database where all identifying details are removed. This part of the study aims to determine whether it's possible to identify eligible participants, collect complete datasets for each participant, and identify any issues that may affect the quantity and quality of data. These findings will help inform a potential future study that could involve 20 or more sites.
Part Two: Research Register
The goal of this part is to create a research register of individuals with PwID and epilepsy. Participants will be approached and asked for their consent to collect their personal and clinical data, which will help identify those willing to take part in future ethically approved research projects. As in Part One, researchers will collect data from medical records. Participants who consent to be included in the register may be contacted by external researchers for future studies. The aim is to facilitate national collaboration by enabling data sharing between research projects, thereby improving the ability to answer more questions and enhance patient care. This part of the study will test whether it's possible to determine screening and recruitment rates at each site, develop and evaluate recruitment processes, and assess how researchers leading other approved studies can obtain permission to use the register. Additionally, it will evaluate whether it's possible to collect a complete dataset for each participant.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a clinical diagnosis of an Intellectual Disability (ID) and epilepsy at participating sites.
Key inclusion criteria (10 listed)
- Clinical diagnosis of ID in medical records.
- Clinical diagnosis of epilepsy in medical records.
- Patient is over the age of 18 years old.
- Under the current care of specialist ID or epilepsy services at one of the three participating NHS Trusts.
- Clinical diagnosis of ID in medical records.
Key exclusion criteria (4 listed)
- Other neurodevelopmental disorders without ID.
- Patient is recorded on the National Data Opt-out as not wishing their data to be used for research/audit.
- Other neurodevelopmental disorders without ID.
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
The set up of a research database consisting of de-identified data focused on People with Intellectual Disabilities (PwID) and epilepsy at three UK NHS sites across England and Wales.
Time frame: End of study (May 2025)
De-identified database
The development of a research register of PwID and epilepsy. Participants will consent to the collection of their personal/clinical data, which will enable the identification of patients willing to take part in other ethically approved research projects.
Time frame: End of study (May 2025)
Research register
7 secondary outcomes
Numbers of eligible patients identified at each site for data collection (De-identified database).
Time frame: End of study (May 2025)
Completeness of clinical data collected (De-identified database)
Time frame: End of study (May 2025)
Feedback collected from sites about any issues around identifying patients and locating the data required (De-identified database).
Time frame: End of study (May 2025)
Screening and recruitment rates at each site (Research register).
Time frame: End of study (May 2025)
Successful recruitment process in place at each site (Research register).
Time frame: End of study (May 2025)
Set up of a formal process including the REFINE Study Oversight Committee to review requests for access to the participant register (Research register).
Time frame: End of study (May 2025)
Completeness of clinical data collected (Research register).
Time frame: End of study (May 2025)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 41298255Musicha C, Neilens H, Stanyard E, Allgar V, Lomax J, Ashford R, Hambly H, Aspinall P, O'Shaughnessy E, Rollinson C, Lennard S, Mclean B, Simpson A, Bowman P, Angus-Leppan H, Watkins L, Laugharne R, Allard J, Shankar R. Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol. BMJ Open. 2025 Nov 26;15(11):e108869. doi: 10.1136/bmjopen-2025-108869.
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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. This study is not recruiting at the moment.
Lance Watkins principal investigator
Swansea Bay University Health Board
Sarah Lennard principal investigator
Cornwall Partnership NHS Foundation Trust
Heather Angus-Leppan principal investigator
Royal Free London NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Intellectual Disability, run by University of Plymouth at 3 sites 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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rohit Shankar (+44 (0) 1752 439831, rohit.shankar@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The set up of a research database consisting of de-identified data focused on People with Intellectual Disabilities (PwID) and epilepsy at three UK NHS sites across England and Wales. (time frame: End of study (May 2025)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780501, which also lists 1 linked publication.
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 17 Jan 2025.