The clinical trial approval was granted from the Therapeutics Goods Administration and the Human Research Ethics Committee.
The trial will be undertaken by the prestigious University of Western Australia (UWA) Centre for Sleep Science (CSS), which has state of the art research facilities and is directed by Professor Peter Eastwood, National Health and Medical Research Council Senior Research Fellow.
Zelda’s clinical trial will target a sample population of people with characteristic symptoms of chronic insomnia, which include difficulty falling and staying asleep on a long-term basis.
A randomised, placebo controlled, cross over study design will be used, where patients are selected at random to be treated with Zelda’s medicinal cannabis formulation or a placebo formulation.
Harry Karelis, executive chairman for Zelda, commented: "This is a very exciting milestone for Zelda.
"We have been meticulously working our way through the regulatory framework to ensure we achieve all necessary approvals.
"This has been a very rigorous process and has taken some time but we are now very well positioned and are the first to undertake a clinical trial of this nature in Australia.
"We are very pleased to have partnered with the leading researchers in this field at the prestigious UWA Centre for Sleep Science, and are confident this clinical trial will deliver the high-quality data we need to further develop and commercialise our medicinal cannabis formulation."
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The company has been focused on targeting its medicinal cannabis formulations to treat a number of disease conditions, and progress its research to clinical trials, the first being chronic insomnia.
Professor Peter Eastwood, director, centre for sleep science, added:
"Australia has been a leader in sleep medicine for many years and our Western Australia based Centre comes equipped with state-of-the-art sleep recording and analysis equipment.
"For this trial we have assembled a team of experts including sleep physiologists, sleep physicians and clinical psychologists."
Zelda has access to patient data in the U.S. and Chile, which shows anecdotal evidence of benefit from medicinal cannabis when used to treat insomnia.
Based on this data and other studies on the safety of medicinal cannabis, the company has worked with the research team at UWA to develop a rigorous research trial protocol to study the clinical efficacy of its insomnia formulations.
It is anticipated that the clinical trial will formally commence in the first quarter of 2018, with patient recruitment expected to commence shortly.
Clinical trials are a key research tool for advancing medical knowledge and patient care.
Population-based data show that about one third of adults have regular difficulty getting to sleep or staying asleep.