(duplicate) (duplicate) A Register for Anti-Epileptic Drugs In ID/PDD

  • Research type

    Research Database

  • IRAS ID

    345110

  • Contact name

    Rohit Shankar

  • Contact email

    rohit.shankar@nhs.net

  • Research summary

    A register for collecting and measuring outcomes of licensed Anti-Epileptic drugs & epilepsy treatments in patients with Epilepsy and Intellectual Disability and/or Pervasive Developmental Disorders

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference

    24/SC/0221

  • Date of REC Opinion

    9 Oct 2024

  • REC opinion

    Further Information Favourable Opinion

  • Data collection arrangements

    Updated Summary (also attached with application)

    In 2014 we received ethical approval to develop a research database register for individuals with an intellectual disability (ID) and/or Pervasive Developmental Disorders (PDD) taking anti-epileptic drugs (AEDs). The purpose of this register is to ascertain the safety of anti-epileptic drugs and treatments. Individuals with an ID and/or PDD (such as Autism) tend to have various co-morbidities and as a result can respond differently to medications when compared with the general population. At the time no method existed for safely and effectively examining the safety of new and existing medications in this vulnerable population. Between 2014 and 2024 five AEDs were studied.

    The research database collects data which already exists in NHS patients’ records. Data from individuals with epilepsy and ID and/or PDD and data from individuals with epilepsy who do not, are compared. This provides valuable information to inform understanding as to whether individuals with ID and/or PDD respond differently. This in turn may inform future treatment guidance. Where an AED or treatment is prescribed for a specific ID population/s then data is collected and analysed in isolation

    NHS patients are asked to consent to confidential and anonymous data being collected from their medical records and shared with the database register research team

  • Research programme

    This project would help identify and clarify the role of newer AEDs (and epilepsy treatments) in patients with ID/PDD. Given the lack of available clinical evidence in this area it is paramount that this research happens. It would benefit all patients with epilepsy and ID. It would increase scientific awareness in AED prescribing.

  • Research database title

    A register for collecting and measuring outcomes of licensed Anti-Epileptic drugs & epilepsy treatments in patients with Epilepsy and Intellectual Disability and/or Pervasive Developmental Disorders

  • Establishment organisation

    Cornwall Partnership NHS Foundation Trust

  • Establishment organisation address

    Fairview House,

    Corporation Road, Bodmin

    PL31 1FB