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NCT06780501: REFINE

Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (REFINE)

Recruiting now Last updated 17 January 2025
What this trial tests

trial in Epilepsy in 600 participants. Currently enrolling.

Timeline
12 September 2024
Primary endpoint
31 May 2025
31 May 2025

Quick facts

Lead sponsorUniversity of Plymouth
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment600
Start date12 September 2024
Primary completion31 May 2025
Estimated completion31 May 2025
Sites3 locations across United Kingdom

Conditions studied

Sponsor

University of Plymouth

Who can join

18 and older, any sex, with Epilepsy or Intellectual Disability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol.
    Musicha C, Neilens H, Stanyard E, Allgar V, et al · · 2025 · PMID 41298255 · DOI 10.1136/bmjopen-2025-108869

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Other recruiting trials for Epilepsy

Currently open trials in the same condition.

Other University of Plymouth trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06780501.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing