Two clinical trials are set to commence in the UK to investigate the potential benefits of cannabis-based medicines for individuals with epilepsy. These trials, involving 500 NHS patients, aim to provide robust evidence on the efficacy and safety of these treatments, which could pave the way for their wider availability within the National Health Service.
The trials are being led by researchers at University College London (UCL) and Great Ormond Street Hospital, with funding from the National Institute for Healthcare Research. One trial will focus on cannabis-based medicines for adults and children with epilepsies that begin in the first three years of life. The second trial will examine patients with genetic generalized epilepsies who have not responded to conventional treatments.
The primary objective of the trials is to determine whether these medicines are safe and effective in reducing the frequency of seizures. Researchers will also assess the impact of the treatments on various aspects of patients' lives, including learning, sleep, behavior, quality of life, stress, and anxiety.
Charlotte Caldwell, whose son Billy experienced a significant reduction in seizure frequency after starting medicinal cannabis, has been a long-time advocate for these trials. Billy used to have up to 300 seizures a day. She expressed hope that the trials' success could prevent other children with refractory epilepsy from enduring the challenges her son faced in accessing life-saving treatment.
Marie Siddans, whose son Harry has severe refractory epilepsy, also voiced her support for the trials. Harry's seizures decreased from a dozen a day to one or two a week after starting prescription cannabis in 2022. She highlighted the difficulties in obtaining consistent and reliable supplies of cannabis-based medicines through private channels.
Professor Helen Cross, co-chief investigator from UCL, emphasized the importance of these trials as a crucial step in determining the safety and efficacy of cannabis-based medicines for epilepsy. Dr. Jo Jones, a consultant pediatrician with a daughter with epilepsy, hailed the trials as a fantastic development that could benefit thousands of patients.
If the trials yield positive results, the data could be used to support the licensing of these products by the Medicines and Healthcare products Regulatory Agency (MHRA) and their subsequent approval for use within the NHS, provided they are deemed both clinically effective and cost-effective. This could offer a valuable new treatment option for individuals with epilepsy who have not found relief from existing therapies.
