Marijuana trial takes off
Ground-breaking study tests effects of cannabis gel on epilepsy patients in NZ.
Amajor medical marijuana trial is under way in New Zealand — testing the effects of a new cannabis gel on epilepsy patients.
The Ministry of Health has given the green light for Kiwis to be part of the ground-breaking clinical trial, investigating the effects of the newly developed cannabidiol gel ZYN002 in stopping or reducing epileptic seizures.
Across Auckland, Wellington, Hamilton and Christchurch, 12-week trials are being conducted with the last wave of New Zealanders being recruited before the trial ends in late November.
Also running across 10 centres in Australia, a total of 210 adult patients will be involved.
As part of the trial, patients must rub the gel into their upper arms and shoulders every 12 hours.
However, the randomised test means neither the recruits, nor their doctors, know which of three gels they are using — high dose, low dose or a placebo.
It’s understood the gel’s cannabisderived contents will hit the brain more quickly and powerfully by being absorbed through the skin rather than being ingested orally.
Auckland City Hospital neurologist and epilepsy specialist Dr Peter Bergin is one of the medical experts overseeing the Kiwi trial. He says provisional research on animals indicates there may be significant results for the 40,000 New Zealanders whose lives are affected by epilepsy. “I tend to be a bit sceptical about treatments which are unproven, but there is good reason to believe that there are compounds from the marijuana plant which will be effective in preventing seizures,” Bergin said. “We are keen to get new treatments available and this is exactly the way we need to investigate cannabidiol, or indeed any other substance — to do a randomised, blind, controlled trial.” Bergin — also vice-president of Epilepsy New Zealand — said the gel’s cannabis extract was not expected to produce any form of psychoactive effect because the extract did not include the tetrahydrocannabinol (THC) compound found in marijuana. One Kiwi recruit, who asked to be identified only as Sandra, was diagnosed with epilepsy in 2012. She had watched her body adapt to traditional drugs and was desperate for a better quality of life. “A lot of people stand to benefit from this research,” Sandra said. “It might enable me to take less drugs and get my life back.”
According to the Ministry of Health, epilepsy affects one to two people in every 100. Some are born with the condition but it can also develop in children and adults, including after a head injury or a stroke.
Hearing, speech and memory can be affected and symptoms can include hallucinations, depression, screaming and convulsions.
Bergin said New Zealand was invited to take part in the clinical trial by Zynerba Pharmaceuticals, the United States developer of the cannabidiol gel.
A Ministry of Health spokeswoman said as long as the appropriate licences and approvals were obtained, cannabis-based products could be prescribed legally and could be used in clinical trials.
“The Associate Minister of Health [Peter Dunne] has made it clear that he is in favour of clinical trials of cannabis-based products to obtain good evidence as to whether these products have the medicinal benefits that many people claim.”
In addition, Dunne has approved applications to prescribe and import non-pharmaceutical grade products for the treatment of three patients.