Australia-based Zelda Therapeutics has completed patient enrolment in a new trial to evaluate the company’s medicinal cannabis formulation for the treatment of insomnia.
The next phase of the study will involve patients undergoing baseline sleep measurements before pharmaceutical dosing.
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Under the randomised, cross over trial, patients will be treated with Zelda’s medicinal cannabis formulation manufactured by Netherlands’ Eurofins Sinensisor with a placebo formulation.
Zelda Therapeutics 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.
“Positive results will mean Zelda will rapidly focus on commercialisation activities in markets where we have existing knowledge, relationships and access to patients.”
The trial, which will be conducted by the University of Western Australia (UWA) Centre for Sleep Science (CSS), includes people with characteristic symptoms of chronic insomnia, which include difficulty falling and staying asleep on a long-term basis.
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By GlobalDataCSS will carry out various baseline measurements of the enrolled patients, who will receive wrist monitors to record sleep activity at home over a period of two weeks.
The trial will primarily collect and evaluate data to identify the effect of the Zelda formulation on the time of sleep onset, sleep cycle duration and quality of sleep.
Zelda will also collect subjective feedback from patients via standard questionnaires, which will be evaluated alongside analytical data collected during the trial.
Preliminary results from the trial are expected to be available later this year.
