Phase 2 Clinical Trial In Paediatric Treatment-Resistant Epilepsy (TRE) Patients
Treatment-resistant epilepsy (TRE) affects ~30% of epilepsy patients and is associated with cognitive, behavioural, motor and neurodevelopmental delays among children. The anti-epileptic potential of cannabidiol (CBD), one of the two major neuroactive components of Cannabis plants has been reported. This study aimed to access the safety and efficacy of an oral CBD capsule (PTL-101) in paediatric treatment-resistant epilepsy (TRE).
In July 2018, we completed our phase 2 clinical study to test Satipharm’s proprietary 50mg CBD Gelpell® capsules in sixteen paediatric patients with very severe, uncontrolled, treatment-resistant epilepsy. This prospective, open-label study demonstrated a marked therapeutic effect of a 12-week treatment period on seizure frequencies among the trial patients.
Key findings of the trial
- Satipharm’s CBD capsules significantly reduced monthly seizures in treatment-resistant children when added to current medications. The median reduction was -82% in the 12-week treatment period
- 9/16 patients (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
- Following 12 weeks of treatment, 8/11 patients (73%) were rated as “very much improved/improved” in overall condition on the Caregiver Global Impression of Improvement scale and 9/11 patients (82%) were rated as “very much reduced/reduced” on that scale
- A mean 73.4% reduction from baseline monthly seizure frequencies was observed
- Two patients fully seizure-free within 5 weeks of treatment
- An additional seven patients reported >50% seizure frequency reduction
Satipharm capsules were safe for use and demonstrated a potent seizure-reducing effect among paediatric TRE patients. This result was achieved with Satipharm CBD 50mg Gelpell® capsules that do not contain the psychoactive cannabinoid THC. This is an important consideration for a treatment where patients may need to take the treatment for some months or years.
Accessing 50mg Gelpell® Capsules
Satipharm CBD 50mg Gelpell® capsules are available in Australia through the Therapeutic Goods Administration (TGA) Special Access Scheme (Category B) or through the Authorised Prescriber Scheme. Patients wishing to access medicinal cannabis products should discuss access with their physician and make themselves familiar with the processes by reading the TGA advice at www.tga.gov.au