A phase 2 clinical trial has found a CBD capsule can reduce the frequency of seizures in children with epilepsy.
Harvest One, through its subsidiary Satipharm has announced positive results with CBD Gelpell® capsules in the management of treatment resistant epilepsy (TRE).
The results have been published in Epilepsy & Behaviour, a bimonthly peer-reviewed medical journal covering behavioural aspects of epilepsy.
The median reduction of monthly seizures was -82% in the 12-week treatment period in treatment-resistant children when added to current medications.
A total of 56% who started the treatment had a reduction of at least 50% in total number of seizures during the entire treatment period, compared to observation.
73% were rated as “very much improved/improved” in overall condition on the Caregiver Global Impression of Improvement scale and 82% were rated as “very much reduced/reduced”.
Two patients were fully seizure-free within five weeks of treatment.
“The significant reductions in seizure frequency… in these very difficult to treat patients, have the potential to be a life-altering event “
Professor Uri Kramer
“The results of our second stage of clinical trials on our Satipharm 50mg CBD GelPell products are very encouraging for the patients we serve, our shareholders and our company,” said Grant Froese, Chief Executive Officer of Harvest One.
“We continue to be focused on the best in class health, wellness, and self-care products at Harvest One and we believe that our unique products, including the proprietary GelPell, will be highly sought after as cannabis legalisation takes hold around the world.”
Epilepsy encompasses a wide range of chronic syndromes characterised by recurrent, unprovoked, and unpredictable seizures. The disease is estimated to affect over 65 million people worldwide, including approximately 0.6% of children under the age of 18
Professor Uri Kramer, director of Pediatric Epilepsy Service, Tel Aviv Sourasky Medical Centre and principal investigator of the trial, says the results compare favourably to other similar studies of cannabidiol.
He added: “Importantly, the significant reductions in seizure frequency, while demonstrating satisfactory safety and tolerability profile in these very difficult to treat patients, have the potential to be a life-altering event for these patients and their families.
“I would be greatly interested in prescribing such a standardised and clinically tested product as Satipharm’s 50mg CBD GelPell.”