• CLINICAL TRIALS

CLINICAL TRIALS

AUTISM

Zelira has brought to market a range of proprietary products that were developed with the Autism community to address ongoing unmet needs.  Through our Launch, Learn and Develop model we continue to research and improve our products through clinical trials and real-world patient data collection.

Emerald Clinics – Observational Trial recruiting now

Zelira are sponsoring an observational study through Emerald Clinics to gather real world evidence to support the use of our proprietary medicinal cannabis based oral oils to improve autism behavioural symptoms such as mood changes, hyperactivity, aggression, self-injury, and meltdowns in people (ages 6 years and above) with autism.

The Observational Trial will be one of the largest medicinal cannabis studies ever undertaken involving a specific range of products in patients diagnosed with autism and will inform the design of future interventional clinical trials, reduce the risks and costs of development, and accelerate the path to regulatory approval.

To find out more about the Observational Trial or to register your interest in participating in the trial please click here or contact Emerald Clinics at 1300 436 363 or info@emeraldclinics.com.au.

Children’s Hospital of Philadelphia (CHOP)

Working with researchers at the Children’s Hospital of Philadelphia (CHOP) in the United States of America, Zelira Therapeutics sponsored an observational trial aimed at paediatric autism, studying the use of cannabinoid-based treatments in controlled clinical settings. The overall goal of the research was to describe the natural history of current use and disposition of medical cannabis products being administered to children as standard of care and understanding the pharmacokinetic and pharmacodynamics of medical cannabis products. Ultimately the trial will identify cannabinoid-based compounds that show effectiveness in the treatment of paediatric autism. Zelira’s proprietary formulations were included in the study. The study has provided a platform for future clinical trials and product development. Results have been submitted to a peer-reviewed journal.

Autism spectrum disorder (ASD) affects approximately 1 in 150 Australians, with its prevalence growing at a faster rate than any other disability.  ASD is defined as a group of complex neurodevelopment disorders characterised by repetitive and distinctive patterns of behaviour and difficulties with social communication and interaction. The symptoms are present from early childhood and affect daily functioning1,2.

INSOMNIA

Zelira’s clinical trial research program has led to the development of a proprietary pharmaceutical grade product with clinical data for chronic insomnia.   Zelira’s mission is to provide doctors and patients with the level of evidence necessary to give them confidence in each new treatment launched.

Zelira conducted a successful world first medicinal cannabis clinical trial targeting chronic insomnia.

Details on the successful results of the Phase 2A clinical trial can be viewed here.

The clinical trial studying patients with characteristic symptoms of chronic insomnia, including difficulty falling asleep, and staying asleep, on a long-term basis was undertaken by the prestigious University of Western Australia (UWA) Centre for Sleep Science (CSS).  The CSS has state-of-the-art research facilities and is directed by Professor Peter Eastwood, National Health and Medical Research Council Senior Research Fellow and Past President of the Australasian Sleep Association (ASA).

Zelira’s proprietary   formulation met both primary and secondary endpoints of the clinical trial, producing statistically significant and dose responsive improvements in Insomnia Severity Index (ISI) scores compared to placebo.  The clinical trial results indicated that treatment significantly improved objective and subjective measures of Total Sleep Time, Wake Time During the Night, Time to Sleep, Quality of Sleep and Feeling Rested after Sleep.  Treatment with the formulation also had no serious health effects and significantly improved subjective measures of stress, fatigue and social functioning.

Insomnia is a sleep disorder that affects approximately 30% of adults, with up to 10% developing chronic insomnia.  Current medicines on the market for insomnia have serious long term effects, providing a need for an effective alternate safe medicine. Zelira’s clinically trialled customised formulation for insomnia is approved for sale in Australia via prescription under the Special Access Scheme/Authorised Prescriber from a medical practitioner.  Zelira is committed to further clinical development of its proprietary formulation in order to achieve product registration.

CHRONIC PAIN

The epidemic of opioid addiction has clinicians looking for a non-drug treatment.  Zelira believes there is clear potential to use cannabinoids to reduce the use of opioids in patients requiring chronic pain management and is expanding its portfolio of cannabinoid-based products that target chronic pain.

Cannabinoid-based medication has the potential to provide an alternative treatment for chronic pain.  The usual treatment for chronic pain is prescription opioids, but these drugs can have serious side effects, including physical dependence.  The epidemic of opioid addiction has become a global crisis, with a high mortality and growing number of people being treated for dependence on painkillers. The rate of accidental deaths due to opioids has doubled for Australians aged 35 to 44 since 2007, with more than two-thirds of these deaths due to pharmaceutical opioids3.

Zelira Therapeutics successfully completed a Phase 1 dose escalation trial in chronic pain patients.  Partnering with the prestigious St Vincent’s Hospital, Melbourne in conjunction with Emerald Clinics in Perth, the clinical trial investigated the use of cannabinoid medications to help patients who are dependent on high doses of opioids to manage their chronic pain. 

Clinical trial results indicated that treatment was well tolerated with no serious adverse effects and there was a dose – responsive improvement in subjective measures of pain, stress, anxiety and depression.

Further details on the successful results of the Phase 1 clinical trial can be viewed here.

Zelira has also partnered with Levin Health, to undertake a clinical trial to assess the safety and efficacy of a proprietary cannabinoid formulation tailored for sports related chronic pain (retired athlete patients).