Becky Hutchinson, commercial director at Beckley Psytech
Beckley Psytech passed a huge milestone recently. We received Clinical Trial Authorisation from the UK Medicine and Healthcare Products Regulatory Agency (MHRA) to explore the effects of psilocybin for treating short-lasting unilateral neuralgiform headache attacks (SUNHA).
SUNHA is a disease belonging to a group of headache disorders called the Trigeminal Autonomic Cephalalgias (TACs), considered one of the most painful disorders known to mankind. It’s estimated to affect approximately 46,000 patients in the US, Canada and the G5 from Europe and there are currently no approved treatments. The condition is characterised by short-lasting headaches that range from severe to excruciating and may occur over 100 times a day.
Assessing the safety and tolerability of psilocybin
Our trial will explore the effects of ascending doses of psilocybin in patients with chronic SUNHA. Eligible SUNHA patients will initially enter a two week screening period during which they will record the frequency, severity and duration of their headaches.
Three low doses of increasing amounts of psilocybin, with five-day intervals between each dose, will be administered to patients. Patients will maintain headache diaries so we can determine the effects of psilocybin treatment on headache frequency, duration and severity. Patients will also complete a series of computer tests after psilocybin administration to evaluate the effects on cognition, such as changes in reaction time.
Ahead of the main study we are planning to run a small proof-of-concept study to evaluate the use of wearables for data capture. The wearable will be used to capture the frequency, duration and severity of attacks, and if the results are successful the wearable would replace the paper diaries in the phase 2 study.
The power of wearables
Data on attacks and episodes of conditions such as SUNHA is typically captured in paper diaries. However, some patients experience up to 200 attacks a day, which presents challenges to the accuracy of what they are able to record. We will be trialling the use of wearable devices (smart watches) so patients can simply tap to record the frequency, duration and severity of their attacks more efficiently.
We believe that overall we’ll be able to capture data more effectively, and this should lead to more robust data on the number and severity of headaches a patient experiences.
Wearables should also bring benefits for trial patients, as diaries can be laborious to complete. Additionally, a wearable can save the patient from having to engage with the condition for longer than is necessary when recording their experiences, reducing psychologically detrimental experiences. We see wearables not just as a useful technology for improving the accuracy of data, but a thoughtful way of creating a better patient experience.
In the long term we believe that digital technology in combination with wearables will be an important part of any patient support programme. By enabling a patient’s condition to be monitored via a wearable, generating both active and passive data in real-time should enable the delivery of more effective, personalised care interventions. Healthcare systems worldwide are still at relatively early stages of progress in terms of their use of wearables to personalise medicine, but we believe we will see significant innovation over the next 5-10 years and are excited to be a part of it.
Read more about our clinical trial authorisation for psilocybin research.