Fifteen patients have been formally enrolled and first results are expected in the first half of 2019.
The trial, which is seeking to better understand the efficacy of medicinal cannabis treatment in existing patients, is being carried out at Children’s Hospital of Philadelphia (CHOP) in the USA.
“Diagnosis rates on the rise”
Zelda and CHOP will work closely with patient advocacy groups during the trial.
The company’s managing director Dr Richard Hopkins said, “We are excited to have this study underway and to be working alongside CHOP to conduct one of the first formal, robust studies of its type in the world.
“With studies showing that around one in 100 people have autism and with diagnosis rates on the rise, we’re focused on addressing a major unmet need for potential new therapies to help treat this condition.”
The study will utilise CHOP’s extensive research infrastructure and is designed to capture a number of key efficacy and safety measures, including clinical pharmacological data using a novel micro-sampling technique developed by CHOP.
Pediatric patients already being treated with medicinal cannabis formulations will be monitored.
Possible future clinical trial
It will lay the groundwork for a possible future clinical trial to generate high-quality, robust and acceptable data to validate the existing anecdotal data amongst patient populations.
The ultimate goal is to identify cannabinoid-based compounds that may demonstrate efficacy in the treatment of pediatric autism.
Developing cannabinoid-based formulations
Zelda is an Australian-based bio-pharmaceutical company focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions.
The company has a two-armed strategy comprising:
- A human clinical trial program focused on insomnia and autism with activities in Australia, Chile and the USA.
- A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer as well as research examining the potential for cannabinoids to treat diabetes-associated cognitive decline.
The company recently dosed the first patient in its medical cannabis insomnia clinical trial with results expected in the first half of 2019.
A randomised, placebo-controlled, crossover study design will be used to treat 24 patients with Zelda’s medicinal cannabis formulation.
The study will collect and analyse data to determine the effect of the formulation on the time it takes to fall asleep, time spent awake and asleep during the night and quality of sleep.
Another recent development has been a distribution and manufacturing strategic partnership with German medicinal cannabis group HAPA Medical.
Under this arrangement, HAPA has first rights to distribute and/or manufacture Zelda’s clinically validated formulations into the rapidly growing German market.