Paternal Exposure Pilot Study
Research type
Research Study
Full title
Paternal Exposure Pilot: Neurodevelopmental outcomes in children and adolescents born to men with epilepsy
IRAS ID
331120
Contact name
Matthew Bluett-Duncan
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
The MHRA has recently introduced new guidance that restricts the prescribing of Sodium Valproate in men aged under 55 years. This is because of evidence from animal studies that there may be a risk of fertility issues in men taking valproate. There is also some evidence of risk to development in offspring of mice, but the data is at present too limited to understand the impact on the development of human children, either in sodium Valproate or other anti-seizure medications. It is important that we investigate so that we can better understand the neurodevelopmental outcomes of children born to men with epilepsy and whether they differ by the anti-seizure medications received. This study is a pilot study and will be completed to help us prepare for a larger study.
We will first investigate how many males with epilepsy that are attending one of the participating hospitals during the study period have biological children aged 6-15 years. We will then investigate how many of these patients and their children would be willing to participate in a study where their child would have a review of their development and will test how we would complete a full assessment in a small group of participants.
Men with epilepsy who had received their diagnosis before their children were conceived, with a child aged 6-15 years 11 months and 30 days, and who are receiving their health care at either the Walton Centre or Salford Royal Hospital will be eligible for participation in this pilot. Participants taking part in Stage 1 will complete a short online questionnaire (5 mins), and those participating in Stage 2 will complete a developmental assessment with their child, and the child's birth mother (1-2 hours). Assessments will be conducted at home, in hospital, or at school, depending on participant preference.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
23/WM/0238
Date of REC Opinion
11 Dec 2023
REC opinion
Further Information Favourable Opinion