First networked study in childhood epilepsy
Next-generation, digital observational study to learn more about the signs and symptoms of rare childhood epilepsy conditions
About the project
Patient group MedCan Support and scientific body Drug Science are proud to announce the launch of a next-generation, digital observational study to learn more about the signs and symptoms of rare childhood epilepsy conditions.
The study will be run using health technology company Alta Flora’s Eva Research Platform, with data submitted by caregivers and parents of children with epilepsy through the platform’s dedicated app, for analysis by Drug Science researchers.
There are over 35,000 children with refractory epilepsy in the UK, defined as epilepsy where a patient's seizures fail to come under control with treatment.
Researchers will gather data via validated clinical questionnaires delivered through a parent or caregivers mobile app on:
- Seizure frequency and intensity
- Prescribed and administered dosages of the drug
- Physiological and behavioural effects of the drug
- Financial costs
The data which will be collected through this observational study is in accordance with the NICE criteria for acceptance as high-quality RWE, and is expected to inform future clinical trial design and data collection methodology.
The study was launched on 13th February 2023 and will run for at least 12 months.
Process and developments
Imperial College researchers create study
Develop research study protocols in rare paediatric epilepsy conditions investigating the effects of new drugs on seizures
Medcan Support recruits, create protocols
Charity group Medcan Support recruits 50 families through their networks. Protocol development and data ownership shared
Recruitment and incentives
Funds required: £65,000 Status: Complete / Fully funded
Our childhood epilepsy study has recruited all participants and received full funding for the next phase. Our goal is to improve treatment for children with epilepsy. Thank you to participants and funders for their support. We look forward to sharing our findings.
Treatment and participant monitoring
Funds required: £125,000 Status: Ongoing / £35,000 total funds
The treatment or intervention phase is the next stage of a clinical trial study where the new treatment approach is administered to the recruited participants. The primary goal of this phase is to evaluate the safety and effectiveness of the treatment approach in a larger group of participants. The study closely monitors the participants' response to the treatment and analyzes the data to determine the treatment's overall impact.
Data analysis and reporting
Funds required: £55,000 Status: Not yet started / £2,000 total funds
At the end of a childhood epilepsy clinical trial study, a report will be prepared with findings and recommendations for future research. If the new treatment approach is deemed safe and effective, it may be approved for use in treating childhood epilepsy, potentially improving the quality of life for affected children and their families.
This study in childhood epilepsy aims to compile the largest data set globally on childhood epilepsy - a valuable asset worth $$$.
Globalising rare disease studies is crucial: families in Canada and Germany have already asked to join the study
We are working with early partners who need a Real World Data collection platform for their projects. If this is you, please get in touch with us.
We encourage you to become an early partner as we are still actively developing our platform and thus open to new ideas and features that may support your project and better patient engagement.