Health and wellbeing company Satipharm has completed the second phase of their clinical trial into the effects of CBD on seizure frequency. The wholly-owned subsidiary of Canadian Cannabis company, HarvestOne, discovered an overall reduction in seizures among 16 paediatric patients.
Clinicians observed an average seizure reduction of 73.4%, with two patients becoming seizure-free in five weeks. A further seven patients experienced a reduction of more than 50%.
Phase 1 of the trial focused on the efficacy of Satipharmâ€™s CBD GelpellÂ® capsule. The capsule contains a 50mg dose of full-spectrum Hemp extract CBD in a large number of soluble gelatine beads. These beads are then placed inside a hard gastro-resistant capsule, to ensure the release of the CBD in the small intestine.
The evidence collected from phase 1 of the trial proved that the Gelpell capsules increased the bioavailability of the CBD. This is because of the hard casing and the emulsion formed by the CBD and gelatine. The hard casing allows the Cannabidiol to reach the small intestine, where it can be absorbed more effectively.
The trial was open to paediatric patients of treatment-resistant Epilepsy (TRE), who had experienced little effect from at least four treatment options. Patients were given the Gelpell capsules, on an open-label basis, over a 12 week period. Eleven of the patients completed the full treatment program.
â€śThis work demonstrated the potent seizure-reducing effect of relatively low doses among pediatric patients with TRE over a 12-week period.â€ť
Following the 12 weeks of treatment, 73% of patients were rated as â€śvery much improved/improvedâ€ť, on the Caregiver Global Impression of Improvement scale.
The results from Satipharmâ€™s trial adds to the existing literature of the effects of CBD on seizure frequency. In the UK, Cannabis was rescheduled, last year, to allow it to be prescribed in rare medical cases. This was largely due to pressure from parents of epileptic children who had seen a benefit from using Cannabis oils.
However, the oils used by the parents contained THC, as well as CBD. Satipharmâ€™s Gelpell capsules contain no THC. Despite this trial providing positive insight into the effects of CBD on seizures, the authors recommend that further trials be carried out.