The next phase of the study will commence shortly with patients undergoing baseline sleep measurements before commencing pharmaceutical dosing.
Positive results will mean Zelda will rapidly focus on commercialisation
Zelda’s executive chairman Harry Karelis said: “This is a significant achievement for Zelda and has the potential to introduce a safe, effective and affordable treatment for patients.
“It is no small feat to be progressing a pioneering study of this nature using medicinal cannabis and is a testament to the quality of people involved that we have reached this point in such a rapid time-frame.
“Positive results will mean Zelda will rapidly focus on commercialisation activities in markets where we have existing knowledge, relationships and access to patients.”
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.
The study will be undertaken by the prestigious University of Western Australia (UWA) Centre for Sleep Science (CSS).
Results expected in late 2018
The study will collect and analyse data to determine the effect of the Zelda formulation on the time of onset of sleep, sleep cycle duration and quality of sleep.
In addition, subjective feedback from patients via standard questionnaires will be collected and analysed alongside the analytical data collected.
It is anticipated that preliminary results from this clinical trial will be available in late 2018.