CLINICAL TRIALS
Celadon is the majority shareholder of LVL Health, which has highly innovative Medicines and Healthcare products Regulatory Agency (MHRA) conditionally approved clinical trial in UK for chronic pain using cannabis-based medicines (CBMPs).
A unique clinical trial
LVL’s CANPAIN trial is a Clinical Trial Investigating a Medicinal Product (CTIMP); this is slightly different from the typical three-phase clinical trial used for marketing authorisation, due to CBMPs being permitted under the UK Specials framework. LVL’s trial protocol was designed (and conditionally approved) in conjunction with UK regulators, such as the MHRA.
The trial is designed to generate robust data that may enable re-imbursement on the National Health Service (NHS), as well as giving doctors more data to prescribe.
Treating chronic pain
An estimated 8 million adults in the UK have moderate to severely disabling chronic pain. This covers a range of conditions, from fibromyalgia to musculoskeletal pain.
LVL’s study is designed to demonstrate the safety and efficacy of cannabinoids for chronic pain sufferers. This is more important than ever given the significant problems and side effects seen with opioid treatments in recent years. Moreover, it has been estimated that opioids only provide long term pain relief for 5-10% of patients1. In 2020, the UK’s National Institute for Health and Care Excellence (NICE) strongly advised against the use of opioids for chronic pain.
PRIMARY END POINT
pain levels
Secondary end points
quality of life, reduction in opioids, sleep improvement, back to work time
Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable1
Trial milestones
LVL’s clinical trial is in two stages:
Initial study
Study commenced in September 2022, allowing for 100 patients
Main trial
Patient numbers may be scaled to up to 5,000 once LVL has approval from Research Ethics Committee (REC) to launch the scaled trial
Ground breaking medicine
The trial uses a leading inhalation device from Ryah, which is connected to a mobile app to collect patient data in real time and deliver a defined dost of medicinal cannabis at a pre-set temperature (to ensure the usage and dosage is as prescribed by doctors). The medicinal cannabis product inside the cartridge is high quality, consistent and made to GMP standards; patients have access to LVL’s specialist pain doctors and 24/7 clinic access.
Promising early results
“Having been very active until two years ago, my condition caused me to be downcast and unhappy. Since starting the medication, I have reclaimed a large part of my life, being able to enjoy the outdoors again and re-gaining mobility. I am now happily walking up to an hour, walking dogs, swimming. Apart from the physical improvement, there has been a remarkable uplift of my mental wellbeing…It is just lovely to rediscover my sense of humour!
“I can truly say that the medication has changed my day-to-day life in a big way. I’ve cut down by over 60% on my opioid painkillers. The medication works far better for my pain than the tablets ever did. It really works well for my joint pains, which has helped a lot with my mobility. Sleep is another great thing…Now I’m getting a steady eight hours a night.”
“I've suffered with neuropathic pain for 20+ years. I have tried almost every other treatment, medication and/or supplement under the sun. None of which gave much improvement and the pain I was in meant I was unable to work or, at its worst, even perform simple day to day tasks. For years I was left unable to focus on anything other than being in severe pain. Cannabis subdues most of these symptoms...As a result I've been able to live a much more fulfilled life, I've been able to contribute to family life (I have a wife and three kids), and for the first time in years I've even been looking for part time work. I've also been able to reduce taking the strong painkillers which I've relied on for years. Thank you all at LVL Clinic…for giving me a lot of my life back.”
“I had to stop work at 33 because the pain was too much. It’s been very depressing. For fibromyalgia, there isn’t anything, no magical pill. I was taking up to 40 tablets a day, including 14 prescriptions such as opiate painkillers, as well as sleeping pills and laxatives to relieve the constipation caused by the painkillers. With LVL’s medicine, straight away my sleep was a million times better. I probably hadn’t had a proper night’s sleep since 2012. My pain levels have completely dropped as well. I am now back at work at the National Grid. I wouldn’t be doing what I’m doing now if it wasn’t for medical cannabis. It’s been life changing.”
How to register
If you have non-cancer chronic pain and are interested in participating in LVL’s treatment programme
