Medicinal Cannabis Clinical Trials For Children With Severe Epilepsy
Medicinal Cannabis Clinical Trials For Children With Severe Epilepsy – Medical Practitioner Advice


Clinical Trial For Children With Severe Epilepsy

The NSW Government has committed $3.5 million to explore the use of cannabis products in providing relief for children with severe drug-resistant epilepsy.

These trials are part of the NSW Government’s commitment to develop a better understanding of how cannabis products can provide relief to children with severe drug-resistant epilepsy.

NSW researchers at the Sydney Children’s Hospitals Network, Dr John Lawson and Dr Deepak Gill, will lead the development and conduct of these trials using cannabis-derived products that are manufactured and supplied by GW Pharmaceuticals.

About the trials

Each trial will have a specific number of participants. This number will be carefully calculated to ensure the study can achieve the most accurate scientific result in the shortest possible time. All trials will be conducted in accordance with good practice for clinical trials and be subject to regulatory approval including review and approval by an appropriate Human Research Ethics Committee. Researchers will be designing the first of the trials over the coming months and are expected to advertise for participants in 2016.

Participating in the trials

The first trial is expected to commence in 2016 following ethics approval. At that stage researchers will advertise for interested participants and publish information on:

  • who can participate in the trial (eligibility criteria)
  • reasons why some children would not be able to participate (exclusion criteria)
  • how researchers will measure the outcomes (eg: by tests or seizure diaries).

Once advertising for participants occurs it is best to meet with your child’s doctor to discuss their condition and whether they might be suitable for participation in the trial.

This is a NSW based trial. Residents from other states and territories in Australia will need to await further information on potential study hospital sites and local involvement. It is best to talk to your local specialist doctor about whether your child may be able to participate. Further information will be available as the trials program is developed.

Compassionate access scheme for Epidiolex®

From 2016 the new partnership with GW Pharmaceuticals allows compassionate access for a small number of children to Epidiolex®. This scheme would be for a small number of children who are not able to participate in a clinical trial due to the unrelenting nature of their epilepsy which has not responded to proven treatments. Details on this scheme will be publicised as soon as available.